Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Vertex is seeking a talented, experienced process analytical technology scientist. Working directly with our contract manufacturing organizations and our internal partners at Vertex, you will solve complex problems encountered in commercial production/manufacturing of drug products utilizing data analytics, spectroscopy, chemometrics, and wet chemistry analytical techniques. You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design, Continuous Manufacturing and PAT. To be considered for this position, the applicant will need to be a collaborative, experienced and competent spectroscopist and data scientist with a history of developing, implementing and troubleshooting spectroscopic methods and technologies in the pharmaceutical industry. A successful candidate will have the ability to influence colleagues and possess strong communication and negotiation skills. The scientist will need traditional lab experience to support research, investigations and continuous improvement, and must be able to creatively devise experiments to advance product and process understanding. In addition to chemometrics, the scientist must also have a strong background in statistical data analysis across pharmaceutical applications. Key Responsibilities Spectroscopic method development/validation/implementation/revalidation and model maintenance (in-house and working with CMO/CRO) On-going support of commercial manufacturing activities utilizing continuous manufacturing processes and real-time release testing Organization and analysis of PAT and continuous manufacturing process data for process insight, investigations and trending Experimental design to support new product commercialization and root cause analysis for existing products Execution of wet chemistry and PAT based experiments for continuous improvement and process and product understanding Data collection, interpretation, trending and statistical process control Method transfers to new CMOs and analytical support for second-source activities Required Education and Experience Ph.D. in relevant discipline and 3+ years of direct work experience, or MS in relevant discipline and 5+ years of direct work experience, or BS in relevant discipline and 8+ years of direct work experience Experience in the pharmaceutical industry, proficient in an analytical development role High emotional intelligence and strong negotiating skills Strong communication and technical writing skills are required Fluent and experienced in spectroscopic method development (NIR, Mid-IR, Raman, laser diffraction) Experienced with chemometrics and multivariate modeling across spectroscopic techniques Expert in a chemometrics software package such as Unscrambler, Matlab, PLS Toolbox, SIMCA, or native instrument software Familiar with pharmaceutical manufacturing operations and online PAT measurements Desired Qualifications: Experience with GUI development for custom software solutions to data analysis and visualization, preferably in Matlab Background in using analytical measurement systems to support development or to find root cause of manufacturing issues, including both PAT and wet chemistry techniques Experience supporting commercial drug product analytical development activities Experience in using on-line and at-line measurements to support QbD and on-going c continuous Improvement Understanding of physical characterization method development (XRPD, laser diffraction, vision analysis, powder flow analysis, etc)
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. We are looking for a researcher who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to innovate new medicines for patients. Key Responsibilities: Develop and execute analytical methods for release and characterization of AAV gene therapy vectors Participate in assay validation and technology transfer to CMO Effectively collaborate with a fully integrated team to facilitate the success of projects Requirements: A Bachelors or Masters degree in Biology, Biochemistry, Cell & Molecular Biology, Genetics or related discipline and 1-3 years of industry experience Industry experience developing cell or molecular-based assays (qPCR, potency, SDS-PAGE, Western Blot) Excellent communication skillswiththe provenability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
We are looking for a dynamic leader with proven success in driving change initiatives to lead the establishment and implementation of the GxP Process Operation Center (GPOC) within Global Quality. This new function is being established with a vision to centralize, simplify, standardize and transform the management, administration and oversight of GxP controlled procedural documents (e.g. Standard Operating Procedures, Work Instructions) and associated GxP training and education. The Senior Director, GPOC will have a passion for quality by design and process simplification, a record of partnering with stakeholders at all levels for delivery of business-enabling processes and demonstrated team leadership, talent development and organizational performance. This individual will report to the Vice President, Global Quality and will lead the implementation of this new function in designing and implementing efficient and scalable models, systems, tools and processes for Controlled Documents and Training/ Education across GxP business areas/processes. This newly established role is critical to transforming our GxP Controlled Documents and Training model for sustainability and effectiveness supporting Vertex growth and expansion across new areas of science, modalities, operations, countries/regions and partnership models (e.g. with third parties). The Senior Director, GPOC will lead a team of approx. 15 colleagues comprised of business-facing partners, process administration/operations, and technical writing and process design/mapping specialists. This role will have overall ownership and accountability of the processes, infrastructure and operations for GxP controlled documents and training. The initial phase of this role (3-6 months) will focus on establishing the GPOC organization, including developing the strategy for transforming the GxP controlled documents and training processes and systems, and introducing the new GPOC model in a phased manner aligned to organizational business priorities and enabling expansion into new areas (e.g. new modalities). Ability to balance both long and short-term objectives, as well as to effectively engage the GPOC team and GxP business stakeholders for value-added impact and change management, will be key to success in this role. This individual will ensure organizational capabilities for process development, education and continual improvement (e.g. Lean/Six Sigma) practices/methodologies in enabling deployment of progressive, effective and fit-for-purpose Controlled Documents and Training models across GxP areas. This individual will partner directly with, and represent GPOC as a member of, the Global Quality Leadership Team as well as Quality governance bodies (e.g. Executive Quality Leadership Team); s/he will also serve as lead/chair or representative to other quality governance (e.g. policies, training) or management review committees as applicable. This individual will partner with management and stakeholders as needed to ensure alignment of strategic and operational QMS goals with priorities of the business and QA for delivery of results necessary to the attainment of our Vertex commitments to serving the patients that need transformational medicines. This individual will demonstrate Vertex Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development and transparency. RESPONSIBILITIES: Broad responsibilities include: QUALITY OVERSIGHT & MANAGEMENT : Oversees and provides strategic leadership of the GxP Process Operations Center (GPOC). Provides strategic direction and management across the design, transformation, and deployment of global models for pan-GxP quality standards (controlled procedural documents) and training. Ensures effectiveness of quality standards and infrastructure (i.e. process design, procedural framework, training/education deployment) in enabling quality outcomes, regulatory compliance and quality improvement across the QMS EXECUTION : Actively champions and technically guides Quality/GPOC and operating staff to translate strategy into results ALIGNMENT : Engages the organization through direct line-of-sight of their work to Vertex's V/S/M and QMS design, deployment, effectiveness and continual improvement ROLE MODELLING: Consistently demonstrates an ongoing commitment to achievement of Vertex and Quality goals, as well as the success of all team members consistent with the Vertex Leadership Model Specific responsibilities include : The responsibilities of this position may include, but are not limited to, the following: GxP Controlled Documents/Standard Operating Procedures and Training Process Ownership and Oversight Provides strategic leadership and oversight to development, deployment and effectiveness of GxP model and infrastructure for standards, procedures and controlled document management ensuring systems (e.g. standards, procedures) are in place to meet applicable GxP regulatory requirements (and guidances, etc.) Ensures capabilities and strategic direction of organization for partnering with GxP business owners (including QA) for deployment/application of SOP and Training processes/models for quality, efficiency and effectiveness Provides strategic leadership and oversight to development, deployment and effectiveness of GxP model and infrastructure for GxP training ensuring effectiveness of programs to educate GxP staff for operational execution enabling compliance, risk management, and quality outcomes Provides strategic guidance and oversight to GxP Standards/Controlled Documents and Training Process Owners in ensuring effectiveness of model design, procedures, tools, templates, systems and training, as well as monitoring of process performance/adherence andleveraging this monitoring and analysis to drive ongoing improvement in training programs and initiatives. Establishes and deploys, in partnership with business leaders/stakeholders, GxP SOP and Training governance mechanisms for ensuring strategic oversight, direction and excellence in execution. Partners with QA and business stakeholders/leaders across GxP areas to ensure models and processes that are fit-for-purpose, effective and sustainable across the QMS Partners with QA and business stakeholders as applicable for ensuring consistency of standards with 3rd parties (vendors, partners, etc.) within the QMS GxP Process Operations Center (GPOC) Establishment and Leadership Provides strategic direction and leadership in translating the GPOC vision into organizational and operational strategies for excellence; i.e. centralized, simplified, standardized excellence in the management, administration and oversight of GxP controlled procedural documents and training Establishes GPOC organization and deploys new operating model in alignment with business objectives and priorities Establishes organizational structure/roles and onboards team to meet capabilities and operational needs for new business model Provides strategic leadership and direction to GPOC model deployment establishing business partner liaison model, and enabling project management, operations management and process administration capabilities Develops and implements strategic plan and objectives for full implementation of GPOC model for delivery of short-term and long-term results in line with GPOC vision and goals Collaborates with stakeholders, process owners and business partners across GxP business areas for effective and proactive management across GxP SOPs and Training processes and support model enabling efficiencies and effectiveness in support of quality outcomes and inspection readiness GxP SOP/Training Model Transformation Provides thought leadership and strategic direction in the development and implementation of pan-GxP roadmap for transforming the models, standards and processes for GxP controlled documents and training as a strategic lever for enabling quality outcomes through leading practices for GxP procedural requirements/SOPs and education Provides strategic change management and leadership to development and implementation of risk-based approaches to streamlining and transformation of existing controlled documents and training Partners with business stakeholders and QA leaders to develop fit-for-purpose models and standards for regulatory compliance, simplicity and flexibility across GxP areas, modalities (e.g. gene/cell therapy, medical devices)/product areas and business models (e.g. third parties, partnerships) GPOC Leadership and Quality Assurance Leadership Team (QALT) Membership Responsibilities Leads and engages GPOC function (12-15 colleagues) for excellence in delivery of organizational and operational strategies and goals in support of Vertex business objectives Responsible for overall delivery and effectiveness of business objectives for team, including budget adherence, staff/team continuity and sustainability and collaboration with QA peers for overall delivery of Quality/QMS strategic and operational objectives Creates a culture of inclusiveness, partnership, opportunity, development, engagement and performance for GPOC team and more broadly across full Quality organization Models leadership, transparency, openness, respect and partnership across interactions with staff, peers, customers and stakeholder groups Partners effectively with QALT members for ensuring a collaborative, progressive and productive culture across quality that engages, develops, retains, and advances staff..... click apply for full job details
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Vertex is actively seeking a Supervisor, Manufacturing Operations. This is an exciting opportunity to lead our second shift in our state of the art manufacturing facility. Responsible for daily GMP operations in the Vertex Drug Product Facility, including the set-up, assembly, operation, disassembly, and cleaning of process equipment. Responsible for daily operation and staff allocations for second shift personnel. Oversees daily work of second shift personnel. Hours are second shift (2-10pm) Monday through Friday. Occasional availability to work on first shift may be necessary for onboarding and training. Key Responsibilities include but are not limited to: Excellent understanding of and strict adherence to cGMP requirements including: Compliance with all on-going training requirements. Following SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility. Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility. Execute and witness batch record instructions during cGMP operations. Maintain facility in an audit ready state. Interface with relevant cross functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product. Supervision of manufacturing personnel Educational Requirements High School or Vocational School Diploma with 10+ years relevant work experience. Basic Qualifications (Min Requirements) Ability to follow verbal and written instructions in English. Visual Acuity. Ability to distinguish between the colors red, yellow, blue and green. Ability to lift up to 50lbs. High mechanical aptitude and the ability to assemble precise equipment with basic and complex tools. Strong organizational skills. Strong communication skills, as well as excellent documentation skills. A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment. Basic computer skills and demonstrated ability to learn new systems and understand new technologies. Supervisory experience Desired Skills Experience with manufacturing systems utilizing advanced computerized control systems and HMIs. Experience with continuous manufacturing. Experience with solid oral dosage manufacturing processes. #LI-BS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Our Internal Audit department is looking for an IT Internal Audit Senior Analyst to join our dynamic and growing team. This individual will conduct technology focused audits, including integrated audits. He or she will be responsible for evaluating risks and controls for our IT infrastructure, applications and systems, information security, and key business processes and operations. Furthermore, he or she will perform oversight of the companys audit of Internal Controls by providing guidance related to IT controls and managing internal and external relationships. Key Responsibilities: Performs IT General Computer controls audits, infrastructure audits, and integrated reviews as prescribed in the annual Internal Audit Plan Perform risk assessments to identify risks relevant to the applicable audit and determine the extent of testing procedures to be performed based on the level of risk defined. Identify opportunities to enhance operational efficiencies Tracks remediation of audit issues noted in internal audit reports Serves as the liaison with IT for IT external auditors and co-sourced consultants Effectively communicates audit results, both verbally and in writing, so they are persuasive, placed in the appropriate context, and understood by the recipient Effectively interacts with IT personnel, external auditors, consultants, and other company personnel including some interaction with higher level employees Performs special projects which are appropriate and relevant to the Internal Audit Department Charter Aids business-focused Internal Audit team members with IT testing as necessary Strong knowledge of industry standards/frameworks (e.g., SOC/SSAE, COSO, COBIT, NIST, etc.,) and leading industry business practices. Minimum Qualifications : Understanding of the technological, operational, financial, and compliance risks that affect information systems design, modification, and processing activities Knowledge of applications, databases, and operating systems. Familiarity with networking, intrusion detection systems and firewalls Information systems auditing skills including ITGCs Strong decision-making capabilities, with a proven ability to weigh the relative costs and benefits of potential actions and identify the most appropriate one An ability to effectively influence others to modify their opinions, plans, or behaviors An understanding of business needs and commitment to delivering high-quality, prompt, and efficient service to the business An understanding of organizational mission, values, and goals and consistent application of this knowledge An ability to train business-focused Internal Audit team members on ITGCs and other relevant IT testing criteria Experience : BS or MS in Information Technology, Computer Science, or a related field Certified Information Systems Auditor (CISA) or CISSP certification preferred. 4+ years of experience in IT Audit, Information Security, or a related field Consulting and/or pharmaceutical industry experience is preferred. #LI-JF1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Responsible for the day-to-day administration and support of the Vertex Data Loss Prevention (DLP) system. Works with Vertex business units to identify critical Vertex data and define new DLP policies to ensure maximum protection. Documents and investigates all suspicious activities escalated by Vertex Information Security tools. Generates metrics for senior leadership on data protection trending and investigations. Coordinate with Vertex business units to identify and protect critical Vertex data. Provide day-to-day support for the Vertex Data Loss Prevention platform. Investigate alerts triggered by the DLP toolset and escalates when necessary. Refines DLP policies to improve data protection. Creates documentation and training material for the DLP platform. Generates metrics for senior leadership. Contributes to the annual budget planning process. Configuration and support of Microsoft Azure Information Protection. Expected to join 24x7 support rotation. Other tasks as defined by management. Requirements: Must have superior communication skills. Must be able to communicate with all levels in an organization. Must have 1-3 years experience directly interfacing with the Symantec DLP platform (DLP, CASB, etc.). Must have 1-3 years experience supporting Microsoft Azure Information Protection. Demonstrated experience dealing with highly confidential and sensitive data. Demonstrated success working with separation-of-duties in a team environment.
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. We are looking for a leader who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to innovate new medicines for patients. We seek an experienced leader who can operate strategically and tactically at the senior director level and is fully committed to advancing manufacturing sciences for advanced medicines. KEY RESPONSIBILITIES Develop analytical strategy for release and characterization of AAV gene therapy vectors, efficiently and independently Establish team responsible for implementation of molecular and cell-based assay platforms to support rapid advancement of multiple programs Accountable for the development, qualification, and transfer of robust assays for release and characterization of early stage AAV products Generate hypotheses and creative solutions to pursue Project goals, set new experimental directions, and overcome obstacles Establish product specifications and contribute to regulatory filings Effectively collaborate with a fully integrated team to facilitate the success of projects, as well as, assists other outside of own project with troubleshooting and methods development Provides technical recommendations broadly within the company regarding own field and plays a key Project Role REQUIREMENTS PhD in Biochemistry, Cell & Molecular Biology, Genetics or related discipline and greater than 8 years experience or Masters degree and 11+ years experience will be considered Direct industry experience leading teams responsible developing release assays and/or work in a Quality Control lab Extensive practical knowledge of a broad range of analytic tools for quantification and characterization of AAV vectors Experience contributing to CMC strategy through participation on global development team Demonstrates advanced judgment balancing technical feasibility, opportunity, and impact Demonstrates initiative and ability to capitalize on scientific creativity and insights Excellent communication skillswiththe provenability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team #LI-JS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
The Continuous Manufacturing Automation Engineer will be responsible for developing and implementing automation solutions for Vertex under the supervision of senior automation engineers. The engineer will support PLC, SCADA and data historian systems. The candidate will develop an understanding of our manufacturing and development processes in order to assist manufacturing and improve efficiencies through automation enhancements. In order to support the development, implementation, commissioning, and validation activities, the candidate will need to read and understand system life cycle documents, such as User Requirements Specifications and Functional Specifications, piping and instrumentation diagrams (P&IDs), and electrical control system and wiring drawings. The desired candidate has experience with GMP manufacturing environments and exposure to automation system programming, data historians, P&IDs, wiring diagrams and/or I/O configuration, system networking, field devices, and/or Ethernet networking and security. Minimum Requirements: Bachelor's degree in Chemical Engineering, Computer Sciences or related field with appropriate industrial experience 2-4 yrs. automation engineering or GMP manufacturing experience Solid oral and written communication skills and ability to appropriately escalate operational issues Experience with at least one of the following platforms: WinCC SCADA, Siemens PLC, Rockwell RSLogix, OSISoft PI historian, Profibus, Instrumentation and control panel hardware Understanding of change control process and system lifecycle documentation Technical writing experience Preferred Requirements: Experience with multiple automation platforms/systems in a pharmaceutical setting Demonstrated ability to develop solutions to complex problems with a creative and innovative approach Determined self-starter with a can-do attitude, comfortable and successful working in undefined and novel areas Effective collaborator with experience being part of large Matrix technical teams to reach successful outcomes under accelerated timelines
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
The Infrastructure Project Manager is responsible for management and implementation of IT infrastructure and information security initiatives aligned with Vertexs business and technology strategy. This is a key role that will require strong understanding of infrastructure technologies and exhibit core project management capabilities in project/resource planning, risk/issue management, and financial management. The project manager will contribute and follow delivery models defined by the Program Management Office. The project manager is expected to build and maintain healthy working relationships and partnerships with business partners, vendors, and peers. Good communication and interpersonal skills are a must to the success of this role. Key Responsibilities: Manage all aspects of project and program engagement including facilitating the definition of the project scope, milestones, goals, deliverables, and budget Defining project tasks, timelines, and resource requirements with input from various internal teams with an understanding of GxP or other compliance requirements Partnering with other business stakeholders, when needed, to develop business cases, process flows, and requirements Adjusts project scope and timing as needed by instituting and applying established best practices and project management methodologies. Develop communication plans and interface with matrix teams, IT leadership, business leadership, and external vendors/partners to execute on responsibilities Building consensus with senior cross-department stakeholders, deliver status reports, requirements documents and presentations to various audiences (technical and non-technical teams) Tracking project against plananticipating events that may require a contingency plan, recommending corrective action, and ensuring that stakeholders are kept informed Managing multiple large projects or a program in a fast-paced environment without compromising on quality and integrity Qualifications A minimum of 7+ years of project management experience, including 3 or more years in leading large complex infrastructure projects Expertise in the use of Project Management methodologies and tools, PMP certification a plus Good understanding of IT infrastructure domains (data center technologies, end user technologies, voice and data networks, and information security) Demonstrated ability to positively manage projects through strong critical thinking, analytical, communication, teamwork, and interpersonal skills Experience in delivering projects in a regulated environment
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
The Senior Statistical Programmer will be responsible for providing hands-on support and technical guidance on clinical project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. This individual will participate in departmental and cross functional technology development and process improvement initiatives. Key Responsibilities: Effectively designs and codes SAS programs for assigned clinical projects(s), consistently meeting objectives of the study Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e. g. , macros or graphical user interface applications) Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives May conduct briefings and participates in technical meetings for internal and external representatives (e. g. , IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA) on assigned projects Performs tasks with minimal instruction from supervisor Minimum Qualifications: B. S. in Biostatistics, Statistics or Computer Science 3+ years of experience w/SAS in the pharmaceutical industry Preferred Qualifications: Masters Degree or PhD in Biostatistics, Statistics or Computer Science 3+ years of experience w/SAS in the pharmaceutical industry Proven record of effective and successful project management tasks and skills Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Demonstrates advanced knowledge of electronic submissions and CDlSC Displays highly advanced knowledge regarding software validation and system development life cycle concepts Communicates effectively in verbal presentations and written technical reports to both internal and external customers
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Vertex Pharmaceuticals, Inc. is seeking an enthusiastic, driven and dynamic Travel Manager to oversee the operations of the global travel program including management of our TMC and Concur Travel globally. This role will also assist in management of the global T&E and Card Programs, daily interactions with our travel partners (hotel, airline, car, etc.) and provide support for our Travel and Expenses Dashboard; identifying trends, implementing updates and managing access as needed. This position reports into the Associate Director, Corporate Services and Head of Global Travel and will provide direct travel support to the Vertex organization. The ideal candidate will have 5+ years experience in a similar role and will have strong analytical, project management, customer service and communication skills. S/he must be highly organized, flexible, and have the ability to thrive in a fast paced environment and handle multiple projects with tight deadlines. In addition, the candidate will have the ability to interface with business stakeholders globally and understand the nuances of interacting with different cultures in a global organization. The position will need to partner and work collaboratively with other members of the Corporate Services Team (Meetings & Events and Card Program Teams) to deliver a high standard of excellence and customer service to the Vertex organization. Data Analytics are an important part of this role, the right candidate must be detailed oriented and have the ability to analyze and identify trends and opportunities for improvement within large datasets. The position will need to work collaboratively with the Associate Director, Corporate Services and Head of Global Travel to identify and action areas of strategic focus. In addition to sound and proven technical capabilities, the role requires strong and mature interpersonal skills and requires a significant amount of collaboration throughout all levels of the organization. S/he should understand the business, corporate culture and be able to keep up with evolving priorities. S/he will be a valuable member of the Corporate Services team and expected to contribute to the broader department strategies and goals. Responsibilities: Oversee the Global Travel Program including smooth operation and consistent service delivery globally Oversee day to day operations of Concur Travel globally Analyze monthly travel data to identify trends and areas of strategic focus Improve engagement and visibility of travel data dashboards across the organization Support the roll out of new Dashboard functionality including training of stakeholders / business partners Implement travel strategy / share shifting as needed Produce Quarterly Travel Newsletters Oversee On-line Booking Tool maintenance globally Monitor and address global travel issues that may arise Support Quarterly Business reviews with TMC, Vendors and Senior Executives Support sourcing RFP initiatives Support and help drive the achievement of Cost Savings Targets Qualifications: Strong analytical skills and ability to manipulate datasets and draw conclusions / identify areas of strategic focus 5+ Years of Travel Management Experience Strong written / verbal communication Strong organization and time management skills Proven experience administering Concur Travel, an understanding of Concur Expense a plus Ability to work autonomously / independently as well as with a team Exceptional customer service skills Proficient in Microsoft Office with a strong emphasis on Excel Ability to collaborate well with all levels of the organization including C-Level Executives and their admins. Respond positively to direction / feedback and take initiative in planning a timely course to project completion Ability to think creatively and strategically to move projects through completion Ability to travel at least 10% of the time - US and abroad Bachelors Degree
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
The Analytical & Purification team within the Medicinal Chemistry Group is seeking an energetic, results-oriented individual with a passion for learning, strong communication and organizational skills as well as a sense of creativity and a mind for the technical. This individual will support the liquid chromatography purification platform within the medicinal chemistry group. This individual will propose and develop improvements in the purification workflow along with implementation of new methods and technologies for high throughput separations. In addition, the successful applicant will possess broad analytical chemistry skills and be able to contribute analytical chemistry solutions to challenges facing drug discovery teams. Key Responsibilities: Purification of medicinal chemistry compounds in a high throughput automated environment Developing and optimizing purification methods for specific compounds and classes of compounds Operating and troubleshooting laboratory and open access instrumentation Consulting with medicinal chemists to develop optimal solutions in accord with project goals Understanding of the drug discovery and medicinal chemistry process Analysis of complex mixtures and developing separation methods Introduction of new methodologies in support of compound purification and lab operations Active participation in discussions in chemistry team meetings Presentation of results to chemistry and project teams Minimum Qualifications: Masters with 0-2 or Bachelors Degree with 0-5 years industrial experience in a relevant setting Preferred Qualifications Experience in chemical compound purification Experience in automation and instrumentation Strong background in informatics and automation, or a willingness to learn Ability to multi-task and deliver on multiple projects and targets simultaneously Advanced knowledge of operation of standard laboratory instrumentation (e.g. liquid handlers, MS, automated chromatography, SFC, chiral chromatography, etc.), as well as demonstrated capabilities in modern methods of synthesis and analysis Positive attitude, customer-oriented focus and an attention to detail are critical to success in this position Track record evidenced by a strong publication or patent record #LI-BS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
We seek a highly independent and innovative scientist to join the Human Assay Technologies group at Vertex. The ideal candidate will be self-motivated with experience in generating novel molecular biology, protein switches and sensors, and chemogenetic tools. This individual will work as part of a collaborative group of cellular/molecular biologists, chemical biologists, and protein biochemists to develop tools and assays for the interrogation of novel genetic therapies for multiple rare, genetic diseases. Preference will be giving to candidates with a track record of success in collaborative environments and innovation in the field. The Human Assay Technologies group supports multiple disease areas in the Vertex drug discovery portfolio at the Boston site. Key Responsibilities: Lead the development of novel tools for gene and protein regulation Independently execute experiments including protein switches and sensors, saturations mutagenesis and small molecule library screens, and targeted protein degradation Analyze, critically interpret and present data to cross-functional project teams, and recommend courses of action based on datasets and discussions with biologists and chemists Be a key member of the Human Assay Technologies team and serve as a strong representative on interdisciplinary project teams Minimal Requirements : PhD (or equivalent degree) with 3+ years post-graduate experience in a relevant discipline (Synthetic Biology, Chemical Biology, Cell/Molecular Biology, Biochemistry/Biophysics) Experience with generating novel protein switches and sensors, peptide library generation, saturation mutagenesis screens, and next-generation sequencing Self-motivation, independence, organization, effective communication and presentation skills; adept in solving/troubleshooting complex problems as well as the ability to navigate a fast-paced work environment A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society #LI-BS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
The Administrative Assistant provides high level administrative support in an efficient, professional manner for 7-10 members of the CF/AAT clinical development medical director group. Responsibilities include establishing work-flow priority based on assessment of tasks and consideration of interdepartmental needs. The work is generally non-routine in nature and is performed using individual discretion under minimal supervision. The Admin Associate III interacts with both internal and external contacts to coordinate the accomplishment of departmental business needs. KEY RESPONSIBILITIES: Prepares and processes departmental paperwork, including non-routine correspondence, complex presentations, and detailed reports requiring analysis of data Initiates administrative procedures for department Coordinates, schedules and manages travel, meetings, seminars series, speaking engagements and conferences for most senior members of the clinical development group. Assists all members of the group with these tasks. May track and distribute updated time-off schedules Handles details of a confidential and critical nature Reviews and edits departmental documents for grammar, style and formatting Ensures the accurate filing and tracking of all departmental documentation, including memos, correspondence, presentations and reports Prepares reports and statistics based on information compiled from various sources on a regular basis Prioritizes and manages managers schedule to include conferences, speaking engagements, travel, and daily meetings Independently coordinates multiple on-going conferenced for departmental staff Plans, schedules and coordinates departmental off-site meetings and events Represents head of department and department staff to internal and external clients Regularly interacts with internal and external contacts to coordinate department/manager business needs May supervise other administrative staff Performs other duties as assigned COMMUNICATIVE AND INTERPERSONAL SKILLS: Exercises independent judgment to optimize internal processes and procedures Demonstrates excellent communication, verbal and written, and interpersonal skills Demonstrates advances proficiency in Microsoft Office Suite Provides guidance to more junior administrative staff Displays ability to independently interpret policies and solve non-routine, complex issues Possesses thorough understanding of departmental and company policies and procedures
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
The Oracle eBS Business Analyst will provide functional and technical support for the Enterprise Business Systems team at Vertex, working primarily with the Oracle Process Manufacturing (OPM) platform and supporting business stakeholders in the Supply Chain business function. Major activities include collaborating with business partners to identify and prioritize areas for opportunity, gathering and refining requirements, determining options for solution design, delivering enhancements, and contributing to technology-driven projects and initiatives KEY RESPONSIBILITIES: Collaborate with business stakeholders to understand their current and future state strategy, needs and requirements from a global perspective Proactively offer solution ideas and potential business process improvements in pursuit of driving efficiencies and meeting business needs Develop and document functional and technical aspects for integrations to the OPM platform Design, perform and document system configurations within OPM Partner with offshore team members and GIS peers for platform and database support, as well as technical development for enhancements and projects Work closely with GIS Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with Sarbanes-Oxley (SOX) and GxP regulations, as well as our GIS system lifecycle and change management requirements REQUIRED SKILLS: Deep experience with OPM - functional and technical ability with configurations, solutions and technical documentation Demonstrated ability to translate business needs and functional requirements into technical or process-driven solutions Strong communication, interpersonal and collaborative skills Solid analytical and problem-solving abilities Experience in GxP environments and the relevant testing requirements PREFERRED EDUCATION AND EXPERIENCE: B.S. and 5+ years of relevant work experience Functional/Technical knowledge in supply chain planning and manufacturing concepts Biotech or pharmaceutical industry and contract manufacturing experience Experience working with SaaS solutions in the SCM discipline Experience with systems integrations with the OPM platform #LI-RS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
We are seeking an exceptional corporate attorney to join the corporate law team at the companys world headquarters in Boston, Massachusetts. The team is committed to a trusting and collaborative culture where we value excellence, professionalism, growth and development. We engage proactively with our business colleagues and their challenges and goals to truly understand them to deliver results for our company and our patients. The individual in this position will be responsible for providing legal support to the companys global research and supply chain organizations and providing support to a number for company-wide contracting initiatives. Key responsibilities of this position include: Draft, negotiate and review contracts for the companys research organization to support multiple internal research programs in a range of disease areas across multiple research sites in the US and Europe. Contracts include sponsored research agreements, service agreements, project statements, material transfer agreements and non-disclosure agreements. Draft, negotiate and review contracts, including supply agreements and process development service agreements for small molecules and genetic therapies, in support of the companys pharmaceutical development and supply chain groups. Interpret existing contracts and advise on contract interpretation issues. Support ongoing company-wide contracting initiatives, including policy development, template standardization and adoption of contract-related technologies. Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align and achieve business strategic goals. Ensure compliance with company policies, procedures and guidelines. Minimum Qualifications : 2-5 years of experience with commercial contracts including in-house, at an academic technology transfer office or law firm. Experience working with IP-rich contracts and in the pharmaceutical and biotechnology industries a plus. JD from accredited law school and license to practice in at least one US jurisdiction. Excellent drafting and negotiating skills. Ability to work independently with minimal supervision. Exceptional organizational and time management skills. Ability to provide internal clients with practical, risk-appropriate and timely legal advice and support. Ability to prioritize competing projects and priorities. Strong oral and written communication skills. #LI-RS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Title: Vice President, Enterprise Architecture Position Summary: Vertex is seeking a unique talent that can play a role at the intersection of science, data and technology to enable life changing impacts to peoples lives. We seek a leader who can work with our business and scientific strategists and drive an enterprise technology architecture that matches high ambitions. Vertex is a fast-moving organization which depends upon multiple technologies to compel our mission forward. Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission, enable Vertex to grow in scale and be a be on the forefront of science and medicine. This position provides leadership and direction to the Information Technology organization related to architecture and innovation. This includes assessing existing, new and emerging technologies, working closely with business areas in understanding business needs and ensure products and platforms are architected in a forward-thinking, scalable, rapid and innovative manner. This position requires a strong sense of urgency and be ability to plan and deliver high quality architectures and solutions in a fast-paced environment. They will define an architecture current state and a future state that aligns with business strategy, and manages gaps, risk, and technical debt. The role will stay on the leading edge of thought/technology in bringing relevant emerging technologies, vendors, best practice engineering practices and innovation to Vertex. This role will help drive the development of short, medium, and long-term plans to achieve strategic objectives. Regularly interacts across functional areas with senior executives to ensure objectives are met. The ability to influence thinking or gain acceptance of others in sensitive situations is important. The VP will require top-tier leadership skills and the ability to recruit and maintain a high-performing organization that achieves significant business impact through technology driven products. Key Responsibilities : Drive technology strategy and influence business stakeholders on strategic product direction Develop and maintain a current/future state architecture that achieves business goals Ability to lead a diverse, multidisciplinary team of systems, cloud, solution and application architects Develop a technology governance model and implement by leading architecture reviews of technology initiatives Lead team through application rationalization Demonstrate and ensure customer focus and align technical solutions with business strategy and objectives Develop in-depth knowledge of strategic, tactical and operational business requirements and develop effective architectures and designs Ability to conceptualize and develop alternative solution approaches, articulating the benefits and tradeoffs of each solution Investigate and understand industry trends and emerging technologies, and plan for adoption where appropriate Proven track record in consistent and timely delivery of high-quality products and services within budget Demonstrated leadership and influence skills across organizational levels and functions Proven track record leading highly effective teams in strategic planning, enterprise and systems architectures and design/development of strategic business solutions Positive thinking, can-do attitude, initiative, and ability to see the whole picture and integrate multiple points of view for the optimal overall Present company evolution based on industry trends Qualifications: Strong knowledge of current digital trends, disruptive forces, and modern technology concepts and expertise in cloud architectures and concepts Minimum of 5 years senior leadership experience, preferably as a VP or comparable level responsibility in a large, global organization architecting and designing technology solutions in an innovative and realistic manner that focuses on delivery Ability to balance high-level identification of innovation opportunities with oversight of technical development processes Demonstrated technical and business aptitude that allows you to understand, translate, and guide discussions and decisions at a strategic enterprise level as well as at a detailed execution level Demonstrated ability for development of global strategic plans including analysis, strategic priorities, capabilities and multi-year plans with supporting operating plans. Ability to translate complex business strategies and needs into strategic priorities that leverage industry trends and emerging technologies while integrating existing architectures, platforms and data. Ability to consolidate complex existing environmental descriptions into an existing Architecture for a current state architecture and the development of an ongoing future state Architecture. Proven track record re-platforming highly-complex and large scale legacy systems for global customers. Experience in leading development of Micro services and containerized application (Docker images or Kubernetes) with expertise in distributed cache and load balancing. Experience with SOA, design patterns, web services technologies, APIs, Applications, Application Ecosystem, and Micro API's. Experience in architecting solutions with information security built-in and that account for and incorporate relevant security governance in the ongoing lifecycle of design and engineering Must have relevant cloud experience and assist in the transition to a "cloud-first" and cloud-platform direction for the company products Ability to build and maintain trusted relationships with customers and stakeholders. Must possess a unique blend of business and technical savvy; a big-picture vision, and the drive to make that vision a reality. A hands-on leader; broadly shares responsibility and accountability of both routine and important tasks and decisions. Holds others accountable by monitoring progress and results and giving effective feedback; able to make tough decisions when appropriate. Professional with a high degree of integrity and honesty. Thrives in a high pressure, fast-paced environment.
Vertex Pharmaceuticals San Diego, CA, USA
Feb 17, 2020
Full time
We are seeking a motivated Computational Genomics Scientist with expertise in NGS data analytics including single-cell analyses and/or methods development to join Vertexs research site in San Diego, CA. A unique feature of Vertex is our focus on understanding the underlying disease biology in relevant primary human tissues and our reliance on developing screening assays using cell cultures developed directly from these tissues. Much of our genomic work supports characterizing the disease phenotype in primary tissue, elucidating the underlying genetic mechanisms of disease, and assessing our cultures and screening assays to ensure they represent in vivo conditions with high fidelity. To these ends, experience in one or more of the following areas is highly desired: single-cell characterization (sc/snRNA-Seq) statistical genetics (GWAS/PheWAS/Fine mapping/Gene burden testing) gene expression analysis (RNA-Seq, eQTL, Pathway analysis) evolutionary/population genetic sequence analysis (Population structure, Homology/Conservation inference) bioinformatics engineering (programming, analytical pipeline development, data visualization, high-performance computing) machine learning (decision theory, clustering, network analysis, text mining) This position is part of a growing global Computational Genomics team focused on delivering on the power of genomics to accelerate all areas of the drug discovery lifecycle. Your key tasks will be to collaborate with cross-functional project teams to design studies, analyze and interpret large-scale genomics data, and communicate results that will have critical impact on the development of cutting-edge, transformative therapies. You will play a key role in bringing together the needs of project teams with state-of-the-art computational biology tools, which will require proactive communication and seamless collaboration with both computational and experimental team members. Key responsibilities: Collaborate with project teams, acting as the computational biology expert, to identify key needs and questions that can be addressed using genomics, sequencing, or bioinformatics Plan studies leveraging genetic and genomic data to answer critical biological questions and accelerate the development of transformational therapies Execute and iterate on analysis of large-scale sequencing data, in partnership with computational and experimental team members Visualize, summarize, and communicate findings to project teams and other key stakeholders Follow relevant cutting-edge advancements in the fast-paced field of genomics, bringing developments in-house or building upon them as appropriate Partner with team members to improve or expand computational methods and develop best-practice, easy-to-use analytical workflows to answer common genomics questions Minimum Qualifications: PhD or exceptional MS with experience in computational biology, statistical genetics, population genetics, bioinformatics, bioengineering, machine learning or a related field A proven track record in the analysis, visualization, and interpretation of genomic and next-generation sequencing (NGS) data Demonstrated ability to work closely with project teams and/or experimental collaborators to design studies and develop analyses to answer scientific questions Familiarity with applying computational methods and bioinformatics tools to large- scale data including proficiency with Linux/Unix systems and high-performance computing environments Familiarity with relevant analytical approaches and underlying assumptions Detail-oriented and self-motivated approach to problem solving with excellent reasoning skills A team-oriented growth mindset that welcomes feedback from others and supports other team members; strong collaboration skills to work across teams and functions A positive attitude that enthusiastically tackles and overcomes challenges Strong organizational and time-management skills to prioritize needs and get things done Excellent presentation and communication skills, including the ability to tailor scientific content to audiences with different backgrounds Preferred Additional Qualifications: Solid scientific understanding of the role of genetic variation in human disease, molecular biology, and cellular biology including specialized knowledge in one or more disease areas Expertise with developing analysis pipelines including coding proficiency with R, Python, or a related high-performance language. Strong foundation in relevant statistical principles underlying analytical approaches including some experience in methods development
Vertex Pharmaceuticals Watertown, MA, USA
Feb 17, 2020
Full time
In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. KEY RESPONSIBILITIES Perform molecular and biochemical assays to support sample analysis from preclinical studies. Assays to be performed include (but are not limited to): Protein extraction, western blot, ELISA, and immunostaining. Coordinate sample storage and analysis. Support assay development using new technologies as required. Execute assays using good documentation practices. Effectively collaborate with a fully integrated team to facilitate the success of projects. REQUIREMENTS Bachelor's (B.S) or Master's (M.S.) degree in biochemistry, cell biology, or related discipline Demonstrated experience in standard in vitro techniques, assay development, and data analysis. Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team. Excellent organizational skills and documentation practices. #LI-JS1
Vertex Pharmaceuticals Boston, MA, USA
Feb 17, 2020
Full time
Vertex is seeking a unique individual with deep experience and passion for cutting-edge, cloud-based serverless data technology. We are looking to help define and implement a step change in science and our ability to help address human disease. Vertex is seeking a unique talent that can play a role at the intersection of science, data and technology to enable life changing impacts to people around the world. We seek a leader who can work with our business and scientific strategists and drive a cloud technology architecture that matches high ambitions. Vertex is a fast-moving organization which depends upon multiple technologies to compel our mission forward. Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission, enable Vertex to grow in scale and be a be on the forefront of science and medicine. This position provides leadership and direction to our newly formed cloud & data function that will help revolutionize the way Vertex leverages data and the cloud to build new learning models in both our scientific and enterprise endeavors. Vertex is looking to embrace serverless as a core principle and enable microservice development as well as the ability to enable learning (ML/DL/AI.) We seek an experienced thought leader who is looking to leverage their deep technology abilities to catapult our mission as a biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. This role will be a founding member and need to process the spirit of a critical thought leader combined with the drive to build and deliver. You will drive the cloud/data team to establish a new platform architecture that enables data to be a strategic source of innovation. You will collaborate and guide our cloud architects a demonstrate an innovative and iterative design, develop and deploy capability. Key Responsibilities : A strong understanding of cloud computing solutions across stacks. Hands-on technical expert and have past experience working as a subject matter expert on cloud technologies. A mix of advanced technology and strategic business acumen as well as a demonstrated ability to engage in senior level technology decision maker discussions related to the business value of services and emerging capabilities A background of deep technical expertise various technology areas such as; Cloud Adoption; Cloud migration and deployment; Digital Transformation; Database and Middleware management; full lifecycle enterprise Software Development; DevOps pipeline build and management; An understanding of enterprise software development tools and methodologies, including typical enterprise application architectures and the ability to write basic scripted or compiled code. Demonstrated ability to think strategically about business, product, and technical challenges. Provide global thought leadership on the serverless application lifecycle Design solutions that are practical, flexible, scalable, reusable, strategic and are achieved through the application of industry proven architectural principles, standards and governance. Technology architects to work with technical leads and developers on component detailed designs and technical specifications to ensure alignment with overall solution designs. Responsible for project level application architecture metrics. Qualifications: Expertise in leading large-scale serverless delivery projects Expertise in experience working with event-driven or microservices architectures Demonstrated industry leadership in the fields of application development, agile delivery and dev/ops Ability to work in a polyglot environment flexibility around learning new programming languages and tools Track record of implementing AWS services and wider serverless ecosystem of tools including Amazon DynamoDB, Amazon Cognito, AWS Step Functions, Amazon SQS and SNS, Amazon Kinesis, AWS IoT, Amazon S3, etc. Understanding of application, server, web services and network security is highly desired Technical degrees in computer science, software engineering, or math highly desired; working knowledge of modern software development practices and technologies such as agile methodologies and DevOps is highly desired AWS Professional Certification, eg. AWS Solutions Architect Professional 10+years development experience with one of the following object oriented languages Java, C# Or C++ 7+ years of application delivery experience 5+years scripting in Linux scripting languages such as Shell or Python and scripting in Node.JS or GO Self organizes and takes action Inspires technical excellence through Continuous learning and knowledge sharing Inspires others and is an avid change agent Leverages broad perspective and innovative thinking to create solutions to problems; Questions assumptions and imagines future possibilities Effectively communicates the recommendation models up to a Leadership / SLT level Proactively acts on ideas to deliver relevant directions and recommendations Understands how to look at an aggregate series of systems and work back to determine critical failure points and non-performant areas