Job Description: A Process Safety Scientist works with a high degree of independence and is a high performer in the laboratory. Adept at designing and executing experimental procedures and able to gather calorimetry information to evaluate thermal hazards of a proposed chemical process and completes work in a resourceful, self-sufficient manner. The Process Safety Scientist will collaborate with process chemists, engineers, and manufacturing personnel to develop an acceptable basis for safety to support scale-up and technology transfer of new chemical processes to both internal and external manufacturing facilities. The scope of work includes the development and execution of process safety testing plans following established guidelines, best practices, and scientific judgment and providing recommendations for safe execution. Instrumentation used in the analysis of process safety includes, but is not limited to, Differential Scanning Calorimetry (DSC), Accelerating Rate Calorimetry (ARC), Thermal Screening Unit (TSU), and reaction calorimetry. In addition, the candidate may be required to flex between the Process Safety, Process Chemistry and Engineering group depending on workload and pipeline prioritization. Key Responsibilities: Working with process chemists and engineers, lead the careful and thorough evaluation of all known and potential hazards for the safe scale-up of chemical processes for preparing pharmaceutical intermediates and active products Develop a safety test plan suitable for the potential process hazards and perform all required process safety testing. Typical testing includes DSC, ARC, TSU, and reaction calorimetry to identify and characterize all thermal and pressure events of the intended and unintended processes Identify all requirements for external safety testing (e.g. dust explosivity) and lead engagement with external vendors and coordinate all interactions Identify and characterize reaction off-gas composition and rates Analyze and interpret experimental data to develop a basis for safety following departmental guidelines, professional judgment, and best practices. Consult and provide recommendations to responsible parties on changes required to ensure an acceptable basis of safety Enter all experimental data and calculations in an electronic laboratory notebook and in collaboration with other process safety colleagues, complete review and witnessing of all experiments. Summarize and document results in process safety test reports Support technology development and workflow initiatives to implement new capabilities and improve efficiency Remain current on process safety science and technology. Maintain active involvement in key professional societies through conference participation, presentations and publications Independently prepares presentations containing experimental data and presents conclusions and recommendations Maintains SOP training compliance requirements Performs other duties as assigned #LI-BS1 Qualification: BS or MS in Chemistry or Chemical Engineering or related scientific field, 0-6 plus years experience. Entry-level candidates will be considered who demonstrate a broad knowledge of analytical instrumentation, particularly for thermal characterization and analysis of energetic materials and have practical experience in organic synthesis and a fundamental understanding of chemical engineering fundamentals. Strong experimentalist who requires no oversight in setting up and performing laboratory duties in running experiments and obtaining calorimetry data Effective self-sufficient communication skills, especially in internal presentations and ability to clearly disseminate ideas Recognized as a technical resource within Vertex Process Chemistry
Job Description: The Senior Director/Head of Regulatory Toxicology and will report directly to the Head of Preclinical Safety Assessment. This dynamic individual will be responsible for the management of the Regulatory Toxicology Group and will have oversight of all regulated safety programs in addition to the expectation of serving at the individual project team level to support progression of novel therapeutic agents through the drug development process. A strong background in Regulatory Toxicology including extensive knowledge and understanding of Good Laboratory Practices (GLPs), ICH Guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences and Dossiers is required. Key Responsibilities: Management and oversight of up to 4 intermediate to senior level regulatory toxicologists Oversight of design, conduct, interpretation, and reporting of all regulatory toxicity studies including resulting risk assessments Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery toxicologists, and affiliated preclinical and clinical development functions, as necessary Coordinate toxicological/preclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners Responsible for lead authorship of pertinent sections of internal and external regulatory documents (IBs, CTXs, INDs, NDAs, RMPs, Expert Reports, etc.) Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety. Build strong scientific collaborations with external groups within both the academic and industrial sectors with the intent of enhancing Vertex's Preclinical Safety Assessment capabilities. #LI-BS1 Qualification: Ph.D. in Toxicology or relevant field; DABT Board certification preferred. A minimum of 12 years of experience in the Pharmaceutical Industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage personnel and multiple scientific projects, and make sound scientific interpretations and risk assessments Proficient knowledge of general toxicology is required, demonstrated expertise in inhalation toxicology an added bonus In depth understanding and working knowledge of regulatory toxicology, GLPs, and US and International Regulatory Guidelines Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
Job Description: Vertex Pharmaceuticals is seeking a Senior Director, Global Marketing for the Pain Program. This individual will be the global brand lead for the Pain Program responsible for the overall launch strategy, collaboration with Research, Clinical Development and Commercial colleagues to ensure commercial success of the program. This individual will possess a desire for team success in a highly innovative company aimed at redefining health and transforming lives with new medicines. The position reports to the Vice President of Global Marketing. Key Responsibilities: Partner with Research, Development & Commercial colleagues to create and communicate the vision and launch strategy to optimize the success of the Pain Program worldwide Provide commercial input into the Clinical Development plan and Regulatory strategy to optimize launch success Co-lead the Pain Late Stage Project Team with Clinical Development across multiple functions to ensure successful execution of the Pain program for launch as well as creation of a clear Life Cycle strategies. Lead the Global Commercial Team to create & execute the Global Commercialization Strategy Ensure global launch readiness through preparation and support of regions and countries Ensure integration and geographic alignment of commercial strategies Partner with Research, Development & Commercial colleagues to create and communicate the vision, strategy, and key global initiatives that will prepare pain assets for launch and lifetime value maximization Lead the Global Commercial Brand. Gather competitive insights in pain and assess impact on Vertex's competitive position Develop global sales forecasts for Pain franchise within the long-range plan, identify key levers in the forecast and create strategies and global tactics to drive success. Partner with the Global Market Access & Value team on the development of value propositions for Pain assets across all age ranges. #LI-SO1 Qualification: Bachelor's degree 10-15+ years of experience in the pharmaceutical, biopharmaceutical or consulting arena, including some combination of marketing, sales, or market research and new product planning. Global or country experience an advantage Preferred Qualifications: An entrepreneurial spirit and ability to develop creative solutions to complex problems. Excellent communication skills coupled with the ability to clearly distill commercial strategies into understandable, and actionable recommendations. Ability to drive disruptive innovation in a category. Thought leadership and team leadership skills. Results oriented and strong analytical skills Ability to manage complexity and ambiguity in a highly matrixed environment Demonstrated ability to manage initiatives that require collaboration across multiple functional areas. An MBA or advanced science/medical degree Launch experience in the Pain market in the US or EU is ideal Global experience working across regions and countries a plus. A strong understanding of the legal and regulatory environment Display solid ethics and demonstrated integrity on the job
Job Description: This role provides technical support for Release and Stability Laboratory (RSL) department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values. Key Responsibilities: Assist in overseeing of RSL method validations and/or method transfer activities to support project timelines. Serve as RSL representative in cross-functional, cross-departmental working teams May execute method validations and/or transfers as needed Support in the managing of RSL change controls, deviations, and investigations. Authors laboratory OOS/OOT investigations and deviations. Helps identify corrective actions to prevent reoccurrence Assist in troubleshooting of analytical methods when necessary Authors and reviews data, SOPs, analytical methods, protocols and reports Participates in compliance related teams working towards the goal of continuous improvement. #LI-BS1 Qualification: A minimum of a Bachelor Degree in science or related discipline is required. 4+ years of experience in pharmaceutical/biopharmaceutical industry with at least 1 year of method validation/transfer experience. Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections. Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements Strong attention to detail Effective communication skills, both verbal and written.
Job Description: The Associate Director will perform scientific statistical functions in support of the company's Global Medicines Development and Affairs (GMDA) area with some guidance and mentoring on new and complex issues. He/She will complete assigned work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. He/she should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. Key Responsibilities. The Principal Biostatistician works under the supervision of the Biostatistics project or program lead. The Principal Biostatistician: Is responsible for all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations. Possesses an advanced understanding of modern drug discovery and development processes. Represents Biostatistics as a member of clinical trial teams, providing strategic input and expert technical guidance to team members. Directs own technical leadership and project teams to more meaningful and/or productive ends. Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results. Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality. Contributes to external interactions with regulators, payers, review boards, etc. Develops statistical section of protocols, including sample size estimates and randomization plan. Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review. Leads implementation of innovative designs and analysis methods at the study level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others. Contributes to departmental working group efforts on various technical and operational issues. Qualification: Minimum Qualifications Ph.D. in Biostatistics and 7+ years of relevant work experience, or M.S. in Biostatistics and 9+ years of relevant work experience Preferred Qualifications: Competence with SAS and R statistical software Demonstrated understanding of statistical methods used in drug development Ability to show critical thinking with logical problem-solving Excellent written and verbal communication skills Excels in a team environment Collaborates well with non-statisticians
Job Description: Vertex Pharmaceuticals Incorporated is a leading biotechnology company that creates new possibilities in medicine to cure diseases and improve people's lives. We currently have three transformative drugs on the market that treat the underlying cause of cystic fibrosis; these drugs represent a revolution in the way cystic fibrosis is treated. We have also developed a deep pipeline, investing billions of dollars into R&D over the past two decades - including more than 70% of our revenues over the past five years - because we are going all in for cures to serious diseases. We are seeking a seasoned, strategic, solutions-oriented, and highly intelligent employment attorney with extensive global experience to join its Legal and Compliance Department at our world headquarters in Boston. The Department is committed to a trusting, collaborative and inclusive culture where we value growth and development. We engage proactively with our business colleagues to truly understand their opportunities and challenges and to drive better outcomes for our company and for patients. The successful candidate will partner closely with Human Resources to support and help drive the company's various global business initiatives by providing practical and sound legal counsel on issues relating to labor and employment law. The candidate will work extensively with the company's Chief Risk and Compliance Officer and Chief Human Resources Officer. Responsibilities will include: Serving as the primary employment law resource for the company. Providing legal counsel to Human Resources and management on employment matters and compliance, including employee relations, recruitment and hiring, performance management, wage and hour, non-disclosure/non-competition, corrective actions, employment agreements, compensation and employee benefits. Responding to and managing employment litigation, audits and investigations. Engaging with Human Resources to develop, revise and implement local and global employment-related policies and procedures. Drafting, reviewing and negotiating employment agreements and contracts. Conducting training on a variety of employment law topics. Participating in various Legal and Compliance Department projects and initiatives (e.g., Culture Committee, Pro Bono and Community Engagement Committee, Talent and Development Committee, offsite planning, strategic planning). #LI-RS1 Qualification: Law degree from a nationally recognized law school and current admission to a state bar. A minimum of 12 years of legal experience as a labor and employment attorney, including experience advising clients on a wide array of employment law issues. A minimum of 5 years of in-house legal experience at a global public company with 2,500+ employees in the pharmaceutical or technology industry, leading an employment law group or being the sole employment lawyer. A deep understanding of non-compete laws and confidentiality protections in the US and globally and experience enforcing employment agreements. Knowledge of employee compensation and benefits, including ERISA. Experience representing companies in threatened or active legal proceedings. Experience investigating and helping to resolve employee relations issues and complaints. Experience with drafting employee handbooks, policies, forms and agreements. Experience training employees on a variety of employment law topics. Effective interpersonal skills and a strong ability to communicate in both verbal and written form with employees throughout the company. Excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex, sensitive and confidential issues. Preference to candidates with experience with UK, French, German, Spanish, Brazilian and/or other jurisdictions' employment laws. Preference to candidates with proficiency in French, German, Spanish, or Portuguese.
Job Description: The Manager - Automation is an exciting opportunity to join Vertex's growing Technical Operations team and facilitate rapid commercialization of new products utilizing continuous manufacturing technology while working with first-in-class commercial operations and external suppliers in an industry-leading Quality by Design (QbD) environment. Vertex Pharmaceuticals currently has three significant commercial products in addition to a robust pipeline with multiple new molecules in various stages of clinical development. The Manager delivers reliably and responsibly on independent activities and is responsible for execution and oversight of internal and external commercial manufacturing operations in technical areas (e.g. Systems, Engineering, Analytical, Drug Product Process). The Manager is a key participant on internal and external cross-functional teams within their technical area for one or more supplier(s). The Manager assists in maintaining effective interactions with suppliers and other key stakeholders. KEY RESPONSIBILITIES: Designs and oversees communication path for data for each external and internal commercial manufacturing operations. Assists Technical Operations personnel in removing repetitive tasks related to data collection, retrieval, and trending. Oversees development strategies to support fast turnaround of industrial / automation related computer issues. Implement streamlined data path of all external and internal partner's Vertex data to one central collection platform. Assess automation / OT needs of Technical Operations, prioritize schedule and executed projects. Qualification: TECHNICAL AND COMMUNICATION SKILLS: Demonstrated experience managing projects in the field of life sciences automation. Demonstrated ability to collaborate with Engineering, IT, and Quality Proficiency in cGMP and Part 11 compliance. Proven ability to lead and influence others in team environment Strong knowledge of manufacturing system integration. PREFERRED EDUCATION AND EXPERIENCE: Preferred Education and Industry Experience includes: A degree in engineering, computer science or related field: BS and 5+ years, MS 3+ years or PhD with 2+ years of relevant work experience. 2+ years of supporting automated manufacturing systems in a regulated pharmaceutical environment. 5 or more years of experience total in engineering or IT experience with manufacturing systems. Preferred Automation Engineering Experience Includes: Working knowledge of Siemens PLC's. Experience with SQL queries, stored procedures, and SSRS reporting. Experience with Industrial Historian development, especially OSISoft PI. Experience working with networked servers and clients, virtualization, remote desktop, and interfacing with corporate IT
San Diego, CA, USA
Job Description: Intern, Discovery Core The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex community. Not only will interns learn about their day-to-day tasks through their specific work assignments, but they will interact and have exposure to our organizational leaders and their teams through a series of Professional Development Workshops. Be FEARLESS... Join us and help kick start the path to your career! Job Description Vertex Pharmaceuticals is looking for a motivated, organized and detail oriented intern to join its large scale cell culture group. The successful candidate will be responsible for supporting activities in the tissue culture lab and learn to operate and troubleshoot lab automation. Qualification: Undergraduate Biology student (entering Sophomore or Junior year) The successful applicant should be able to work approximately 20 hours/week during school and approximately 40 hours/week during the summer. Comfortable working independently as well as in team settings. The ability to follow detailed protocols and strong problem-solving skills are a must. The intern should possess an interest in utilizing and maintaining automated liquid handling systems, and an interest in cell culture. Detail oriented with the ability to manage multiple priorities while meeting expected deadlines Excellent verbal and written communication skills Highly motivated and have an excellent work ethic Ability to work in a fast paced environment Adaptable to change Proficient in Microsoft Suite Must be currently enrolled as an undergraduate in a college/university Wet lab experience is preferred Minimum grade point average of 3.0 is preferred
Job Description: We are seeking a seasoned life sciences attorney to lead our small but mighty FDA Regulatory Law group and to join our whip-smart and highly respected Legal and Compliance Department at the company's world headquarters in Boston, MA. The Department is committed to a trusting and collaborative culture where we value growth and development. We engage proactively with our business colleagues to truly understand them and to deliver results for our company and for patients. If you thrive in a fast-paced, hands-on, and team-oriented environment where you can have a big impact on the organization, we'd love to talk to you! The individual in this position will be the point person for providing strategic and solutions-oriented legal advice to a broad spectrum of internal clients, including senior leadership, from the following functions: Clinical Development, Real World Evidence, Clinical Trial Transparency, Translational Medicine, Publications, Managed Access, Quality, Regulatory Strategy, Regulatory Policy, Safety, and Global Marketing. This role will be highly visible and will have the opportunity to directly contribute to Vertex's success, and thus candidates must display a high level of executive presence and leadership competencies. The position has one direct report (an attorney) as well as responsibility for managing a budget. This position will report to the Vice President of Commercial and Regulatory Legal. Key Responsibilities Advising business leaders on strategies and tactics in a way that advances the company's business while addressing legal risks and protecting the company's integrity and reputation. Providing practical and timely advice on various corporate initiatives and activities, such as clinical development of investigational compounds (including design of studies to support regulatory approval), regulatory strategy for new products and line extensions, Hatch Waxman issues and life cycle management, design and use of real-world studies to support regulatory submissions, investigator meetings, expanded access programs, publication issues, FDA inspections, GxP compliance, recalls, clinical trial reporting, EMA Policy 70, and clinical trial data sharing. Helping to draft responses to proposed laws and regulations, FDA guidance documents, and industry group policy positions. Providing regulatory law support for transactions, including conducting regulatory due diligence, negotiating key regulatory terms, and supporting post-transaction integration activities. Providing regulatory law support to brand attorneys on advertising and promotion issues. Keeping abreast of regulatory developments affecting clients (e.g., cell and gene therapies, mobile medical applications, track and trace) and anticipating potential obstacles in obtaining desired regulatory outcomes. Providing oversight and guidance on matters handled by direct report. Participating in various Legal & Compliance Department projects and initiatives (e.g., Culture Committee, Pro Bono & Community Engagement Committee, Talent & Development Committee, Diversity Committee, offsite planning, strategic planning). #LI-RS1 Qualification: JD from an ABA accredited law school and member of a state bar. Minimum of 12 years' experience providing FDA regulatory advice to pharmaceutical, biotechnology, or medical device companies, whether in-house or at a law firm with a nationally recognized FDA life sciences practice Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, promotion and scientific exchange, Hatch-Waxman, Orphan Drug Act, DQSA, clinicaltrials.gov reporting, and fraud and abuse. Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products, including FCPA, competition law; OIG guidelines and opinions; Sunshine Act/transparency laws; privacy laws, product liability, and industry standards (e.g., PhRMA guidelines, ICMJE and GPP standards, ACCME guidelines). Skills/Abilities Consummate team player with excellent judgment and interpersonal skills. Ability to constructively counsel and influence clients in making the right decisions, and to make tough calls. Capacity to simultaneously handle a variety of complex legal matters with minimal guidance Demonstrable experience taking ownership of issues and providing timely, actionable advice. Exceptional written, oral and presentation skills.
Job Description: Vertex's Technical Operations Drug Product team has an exciting and challenging opportunity for you to facilitate rapid commercialization of new products utilizing traditional and continuous manufacturing technology in our industry-leading Quality by Design (QbD) environment. Vertex has three significant commercial products in addition to multiple new molecules in various stages of clinical development. The successful candidate will have the opportunity to add significant value in several areas: Process Validation and New Product Launch Develop and execute process validation strategies under quick timelines by working with cross-functional teams including formulation development, analytical, quality, supply chain and regulatory to ensure creative and efficient implementation. Formulate validation master plans, validation protocols, validation reports, continued process monitoring plans and statistical sampling plans, among other important strategic documents. Commercial Production Support ongoing internal and external commercial manufacturing activities Resolve complex commercial manufacturing issues Conduct commercial continued process monitoring and process improvements. This includes the opportunity to apply statistical process control to recognize data trends and then implement improvements. Technology Transfer Direct technology transfer to enable both continuous and traditional manufacturing at external suppliers. Provide technical input to Supply Chain, Quality, and Regulatory to formulate global regulatory strategy for qualification of new manufacturing sites. The candidate must be an excellent collaborator and proven technical leader with experience in a cGMP pharmaceutical drug product manufacturing environment. The successful candidate will have a solid background in solid oral dosage form manufacturing. Experience with spray dried dispersion technology (and its related processes and unit operations) is a plus. Qualification: Minimum Qualifications: Degree in a pharmaceutical science or engineering discipline: BS and 5+ years, MS 3+ years or PhD with 2+ years of relevant work experience Experience in cGMP manufacture of commercial or late phase clinical products. Experience with technology transfer and scale up is a plus. Process Development of solid oral dosage forms and a sound understanding of the pharmaceutical development process. Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach Proficiency with Quality by Design (QbD) concepts and design of experiments required. Familiarity with statistical process control (SPC), complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.) is a plus. Must be a committed team player and collaborator Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment Willingness and Ability to travel up to 30% of the time. Preferred Qualifications: Experience with Process Validation Experience with commercial manufacturing of biologics and/or parenteral products is a plus but not required.
Job Description: As part of the Business Development Transactions team, this individual will be responsible for supporting the negotiation and execution of a range of business development transactions, including collaborations, licenses, financings, mergers and acquisitions, all aimed at helping Vertex achieve its strategic objectives and create sustained revenue and earnings growth. S/he will work closely with and report to the Head of Transactions. Key Responsibilities: Working collaboratively with relevant stakeholders to develop proposals for structuring and negotiating a range of deals Soliciting internal feedback on deal issues and ensuring feedback is incorporated into deal documents in a manner that addresses Vertex's business needs Actively tracking issues in deal documents and developing thoughtful solutions Helping to develop negotiation strategy and leading or supporting counterparty negotiations Preparing supporting documentation for transactions (including external presentations, opportunity reports, management presentations, Board memos and other deal communication materials) Working seamlessly with the External Innovation team in their identification and technical evaluation of potential opportunities and the Alliance Management team in their integration and management of collaborative relationships Contributing positively to the culture of a small, mission-oriented, collegial team Some travel required #LI-RS1 Qualification: 5-10 years business development experience, preferably in a transactional law practice; deal sheet demonstrating experience and specific roles Advanced degree required, JD preferred In-depth knowledge of the drug research and development process and the regulatory, reimbursement and commercial environments Ability to simplify complex ideas/concepts and synthesize and summarize a complex set of facts Ability to develop creative solutions to complex problems Adept at handling multiple projects and tight deadlines in a fast-paced environment while maintaining attention to detail Comfortable reading and understanding complex legal agreements Ability to work cross-functionally within and beyond the Business Development organization -- Experience working with both internal and external multidisciplinary teams including R&D, Commercial, Legal, IP, Finance and Operations Excellent written and verbal communication skills and ability to "think on your feet" High emotional intelligence and ability to forge relationships internally, as well as externally. A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases