Bristol-Myers Squibb Company

  • Bristol-Myers Squibb Corporate Headquarters 430 E. 29th Street, 14th Floor, New York, NY 10016
  • https://www.bms.com
Bristol-Myers Squibb Company New Brunswick, NJ, USA
Mar 15, 2019
Full time
Responsible for the commissioning, qualification, and validation activities across areas of Clinical Supply Operations(Parenteral, Oral Solid Dosage, Packaging and Logistics) and Research and Development External Operations Kilo Lab facilities by utilizing experience in quality, safety, and computerized system regulations applied to Clinical Supply Operations and Bulk Pharmaceuticals. The individual must possess strong commissioning, qualification, and validation fundamentals; and a strong understanding of equipment, facilities, and systems within pharmaceutical and bio-pharmaceutical areas. Duties include planning and executing temperature mappings, sterilization, decontamination, and SIP/CIP studies; controls and instrumentation protocols; project management. Knowledge of cGMPs, EU guidelines, USP, ISO, GAMP, Electronic Records, and Data Integrity industry practices; and proficiency in managing external resources to lead a multi-disciplinary team on the execution of commissioning, qualification and validation activities. Collaborate with various groups within product development & technical operations, to complete shared objectives. Act as a lead role in discussions with quality and regulatory compliance and be comfortable debating differences of philosophy. Generate, review, and execute commissioning, qualification, and validation documents. Provide validation support of equipment re-qualifications and periodic review activities. Maintain GMP facilities in a qualified state at all times. Maintain validation life cycle and validation master plans. Generate risk-based impact assessments, validation project plans, and schedules. Prepare and respond to audits, including audit findings. Required: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Chemistry or a related field plus 5 years of experience reflecting demonstrable ability in the skill set described above. Other Qualifications: In lieu of Bachelor's degree plus 5 years of relevant experience the employer will accept a Master's degree in Chemical Engineering, Mechanical Engineering, Chemistry or a related field plus 3 years of experience reflecting demonstrable ability in the skill set described above.
Bristol-Myers Squibb Company Massachusetts, USA
Mar 15, 2019
Full time
The Assistant Automation Shift Engineer is an entry-level Automation/IT position within Bristol-Myers Squibb at Devens, MA. The role will serve as an individual contributor participating in initiatives that support 24/7 manufacturing operations. As such, this Assistant Automation Shift Engineer will be assigned to the first or second shift. Individual will be expected to cover some weekend shifts as required by business needs. Hours and shift schedule are subject to change as dictated by work force plans. MAJOR DUTIES AND RESONSI-BILITIES Support 24/7 manufacturing operations that includes need based shift coverage and weekend coverages. Participate in Run the Business initiatives such as change implementation, investigations, corrective actions, and manufacturing support. Implement system modifications by following appropriate standard operating procedures. Troubleshoot and remediate system configuration/infrastructure issues. Collaborate in investigations of proprietary automation software/hardware problems with vendors. Communicate proactively with supervisor and colleagues, highlighting issues and proposing solutions. Follow applicable standard operating procedures while working in validated systems. Be the site point of contact for IT/Automation planned/ unplanned outages and coordinate outage executions. Position Requirement: Bachelor's degree in Chemical Engineering, Electrical Engineering or equivalent combination of education and technical experience. 0 - 2 years working experience with control systems or manufacturing systems Preferred Emerson DeltaV, Emerson Syncade, OSISoft PI, or Rockwell Logix Theoretical and applied knowledge of computerized systems and Systems Development Life Cycle. Working knowledge in computerized systems (Preferred Emerson DeltaV, Emerson Syncade, OSISoft PI, or Rockwell Logix). Understanding of expectations working in regulated industries such as Biotech, Pharmaceutical, Medical Device or Food-Beverage is a plus. Must demonstrate an ability to understand and apply software solutions. Must demonstrate an ability to troubleshoot complex problems on highly automated equipment. Must be able to successfully work independently and within teams. Must be able to work in a fast paced multi-tasking environment. Must have strong interpersonal skills and ability to work in a team environment. Excellent verbal and written communication skills.
Bristol-Myers Squibb Company Princeton, NJ, USA
Mar 15, 2019
Full time
Principal Scientist in Cellular Immunology Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Job Responsibilities The successful candidate will be responsible for leading independent project(s) in the areas of immunological intervention of autoimmune diseases. As a part of the matrix team leadership in this area, this leader will be a key immunology representative on various pre-clinical small and large molecule drug discovery teams. She/he will advise and execute the in vitro and ex-vivo discovery immunology experimental plans. As part a larger project, s/he will also interface with other key functions, such as DMPK, Tox, Chemistry, antibody and protein discovery etc. Responsibilities also include scientific management of and working closely with her/his direct report immunology scientists. This individual will report to Immunology Group director; required to lead independently with minimal scientific supervision. Job Requirements The successful candidate will have a PhD in Immunology with 10-15 years of postgraduate work experience, substantial portion of which would be in biotech, Pharma or biopharma setting. At least 3-4 years of post-doctoral training in reputed immunology lab, and publications in key immunology journals are required. Specific expertise in one or more areas of adaptive and innate cellular immunology: such as myeloid biology or immune tolerance expertise will be important characteristics to have. This position requires extensive technical experience with primary immune cell-based functional assays such as primary cell differentiation, proliferation, cytokine measurements, receptor binding and occupancy, and cellular signaling using appropriate biochemical and pharmacological techniques. This position requires extensive technical experience using latest flow-cytometry analysis and sorting techniques, and a working knowledge of bioinformatics. Evidence of supervisory responsibility in academia or industry, and/or project leadership, with crisp communication skills and evidence of a publication record in peer reviewed immunology journals will be key differentiators in candidate selection.
Bristol-Myers Squibb Company Princeton, NJ, USA
Mar 11, 2019
Full time
Innovative Medicines (IM) is an integrated Clinical Development and Commercial organization that leads our Cardiovascular, Fibrosis, and Immunosciences business. The IM portfolio, which consists of a broad and compelling R&D pipeline and marketed products such as Eliquis and Orencia, is a critical component of BMS's current and future business. Summary The IM Business Operations Lead will be part of IM Strategy & Operations and will have a wide-ranging set of responsibilities to support our R&D priorities. These responsibilities may include but are likely not to be limited to: Leading a portfolio of initiatives to optimize IM's R&D operating model and enabling capabilities. Fostering an effective partnerships key external/internal partners and IM's anchor CRO. Measuring performance through KPIs and developing actionable plans to improve execution. Ensuring a robust Quality Management System and Learning Strategy for IM. Scanning for innovation and converting ideas into actionable plans for our IM model. Providing strategic planning, budget, and headcount management support. Cultivating a culture of high performance, excellence, and innovation. Supporting the annual strategic plan and budget process within IM. The successful candidate will have a proven track record of (1) leading a wide-array of strategic and/or operational projects which delivered measurable value, (2) leading cross-functional teams to establish and achieve a shared set of goals, (3) guiding through ambiguity to define an actionable plan of action, (4) fostering effective relationships with executives, management, and peers, and (5) crafting and delivering clear, concise, and compelling communications. Required Skills BA/BS degree required; advanced degree preferred. 7-10 years drug/clinical development experience preferred, ideally with global experience. Experience in project management with the ability to develop clear action plans and execute. Highly effective written and verbal communication and interpersonal skills. Experience collaborating with Senior Management. Ability to build relationships and influence, and drive organizational engagement.
Bristol-Myers Squibb Company New Brunswick, NJ, USA
Mar 10, 2019
Full time
This position is needed to manufacture clinical supplies. Tasks for the function: Adheres to the established manufacturing schedule for all assigned batches from start to completion. Assists in the manufacture of pharmaceutical oral dosage products for use in clinical studies. Follows all written procedures, SOPs, cGMP regulations and safety requirements during manufacturing. Carries out operations with strict adherence to cGMP and OSHA requirements. Participates in all manufacturing activities of assigned batches and completes all required documentation. Performs equipment setup, batch execution including completion of associated batch documentation and equipment logs and equipment cleaning. Enters data into computer terminals when required. Education Requirements: Two-year Associate Degree in Science related to pharmaceutical development or equivalent. Proficiency in use of computer programs/systems is essential. Technicians must maintain their skills and knowledge current with advances in the field of pharmaceutical development. Incumbents may attend internal or external training courses as approved by management.
Bristol-Myers Squibb Company Princeton, NJ, USA
Mar 08, 2019
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Responsibilities: As lead for NVAF strategy, the incumbent will partner closely with key internal stakeholders, including WW Medical, US and WW Commercial and the Alliance Partner to develop strategic plans and to execute medical plan related to NVAF. Manages 1-2 Eliquis Medical Scientists Cooperates with cross-functional medical team members to deliver key medical activities related to NVAF, including advisory boards, congresses, proactive messaging, reactive medical communication, publication strategy. Anticipates needs of field medical team, including training and content Effectively partners with commercial organization on both strategy and execution related to NVAF and in light of evolving healthcare landscape. Engages with external Thought Leaders to gather insight into unmet medical needs and educational gaps related to diagnosis and treatment of NVAF. Leads the annual medical strategy planning process and works closely with Medical Lead to ensure coordinated execution of the plan by members of the extended US Medical matrix team. Qualifications: MD/PharmD/PhD or equivalent degree with experience in cardiovascular disease and/or thromboembolic disease. At least 10 years of clinical experience in cardiovascular or thromboembolic disease or industry experience in research and development or medical affairs is preferred. Experience working within an Alliance or Joint Venture would be extremely desirable. Critical thinking skills related to data are a must. Strong interpersonal and communication skills. Proven leadership in managing complex interactions and gaining alignment of stakeholders.
Bristol-Myers Squibb Company Princeton, NJ, USA
Mar 08, 2019
Full time
The BMS Medical organization strives to be recognized throughout the world as the most accomplished and respected BioPharma Medical organization. In BMS Medical, you will have the ability to impact the lives of patients by developing and ensuring the safe and appropriate use of our medicines. The Medical organization plays a valuable and unique role in unlocking the full potential of our scientific and medical innovation. Medical bridges clinical development with clinical practice and gains broader knowledge of the healthcare industry. The US I-O Medical Scientist and tumor lead for GI cancers plays a critical role in forging broadly aligned tumor strategies, translating them into tactical plans, and leading the execution of these plans. Critical Responsibilities include Demonstrate forward thinking by understanding emerging trends, anticipate future obstacles, risks, and business opportunities, and proactively create strategies, tactics, and contingency plans Collaborate with GI Development and Headquarter Medical teams in the development of long-term tumor strategies Lead the US cross-functional medical matrix teams in the development and execution of US medical plan Partner with US Commercial & Access organizations to integrate medical perspectives into the commercialization process and ensure appropriate alignment between commercial and medical Contribute to shaping the competitive strategies by communicating the US perspective for the target product profile, label language and value considerations Be the content expert of the assigned tumor, lead the development of field resources, and conduct effective training for field teams Identify data gaps, develop strategies for US non-registrational data generation, and lead the review, approval, and timely execution of investigator sponsored research Develop and maintain long-term, trusted relationship with external thought leaders and investigators Requirements Advanced scientific degree (MD, PhD, PharmD) Prior pharmaceutical industry experience in medical or clinical research Familiarity with all phases of oncology drug development, including clinical development, regulatory and life cycle management, is desirable Therapeutic area scientific & clinical expertise is desirable Experience in leading complex projects and diverse, high performance teams Strong interpersonal skills to navigate complex situations and build alignment with key stakeholders Demonstrated ability to execute and deliver results in a deadline-driven environment Clear and effective verbal & written communication skills Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D Qualifications Experience in pharmaceutical industry.
Bristol-Myers Squibb Company Cambridge, MA, USA
Mar 08, 2019
Full time
This Principal Scientist position will join the Cancer Resistance Biology Research Team at Bristol-Myers Squibb in Cambridge, MA to lead preclinical drug development against therapeutic targets at the intersection of intrinsic tumor genetics and the extrinsic tumor microenvironment. Summary The qualified candidate is a highly motivated, interactive, and creative individual who possesses substantial experience in studying tumor biology and genetics, and experience or strong interest as to how these features impact immune responses to the tumor. The candidate will be an experienced program team leader and drug hunter. S/he will be an effective manager and mentor to more junior PhDs and associates. Since BMS is a matrixed organization, the candidate will be expected to effectively collaborate with colleagues in supportive line functions (including oncology, immuno-oncology and immunology, medicinal chemistry, candidate optimization and translational medicine) to advance preclinical development of therapeutic candidates to early clinical development. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams, senior management and at external scientific meetings. The candidate will develop external partnerships/collaborations to advance internal programs, as appropriate. Similar they will be involved in the evaluation of partnering and other business development opportunities. S/he will be responsible for building and supervising a group of up to 2 PhD Investigators and 4-6 research Scientists/Associates. There will be less than 10-20% travel. Qualifications Required A Ph.D. degree with 8- 10 years of relevant industrial experience in cancer biology and genetics, immnuo-oncology or a closely related field Industry experience with demonstrated abilities to drive preclinical development from target ID to clinical candidate selection, especially experience in small molecule drug discovery A proven track record in the field of cancer biology and genetics, as evidenced by publication record Demonstrated expertise to independently apply bioinformatics and data mining through multi-variate analysis; ability to effectively interact with core bioinformatics colleagues, as well as to use desktop tools/interfaces and public databases Management/supervisory experience is essential. Excellent oral and written communication skills, as well as the ability to effectively present scientific data and concepts to international standards. Preferred Experience or the ability to innovate in novel preclinical in vitro , in vivo and ex vivo oncology model development that enables bridging from tumor biology to host immunity Experience in studying the tumor stromal compartment Ability to effectively interact with core bioinformatics colleagues, as well as with translational research scientists to generate testable hypotheses for targetable nodes that drive cancer resistance to current immuno-therapies. Reports 1-2 PhD Investigators, 4-6 Research Scientists/Associates
Bristol-Myers Squibb Company Princeton, NJ, USA
Mar 07, 2019
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. JOB DESCRIPTION Work with the BMS ONO I-O Joint Development Team Leader and JDT matrix team members to enable the global oncology strategy to be executed in Japan, Korea and Taiwan. Review and communication of strategy, medical data, trial designs, protocol amendments, regulatory updates, study timelines and other information relevant to the BMS-ONO oncology book of work Work consistently in a matrix environment MD, PhD, Pharm D or other health related degree in scientific field with an understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge. The position is based in the Princeton, NJ area. JOB REQUIREMENTS ROLE IMPERATIVES This role will be a key contributor to BMS/ONO I-O joint development in Japan, South Korea, and Taiwan of collaboration assets including regular development meetings, management of collaboration book of work, and regional specific strategy. Active member of JDT matrix core team, which includes Clinical, Operations, Project Management, Regulatory, Alliance Management and Finance, including responsibility with project manager for action items and key follow-up activities. Work with Program Leads, team members and internal governance bodies to translate the FDT strategy into trial options, protocols and action plans Work with Program Leads and CTLs on tumor teams to prepare and regionally tailor materials for external JDT and other BMS-Ono governance and interactive forums A close relationship with BMS's Japan, Korea and Taiwan R&D will be important. This individual will work closely with Translational Medicine (TM), a rapidly expanding area of growth in connectivity between Ono and BMS; particularly as it relates to pan-tumor, pan-trial, and exploratory activities including but not limited to TMB, PD-L1, GEP and other emerging biomarkers and CDx. Help organize BMS-Ono events including face-to-face clinical forums (e.g. design agenda, prepare materials with clinical teams, logistics coordination) As needed, support Program leads to produce clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview; support generation and coordination of clinical documents and deliverables in support of regulatory filings The role may also include support of general contributions to OCD (PSC, CTL Forum, etc.) May require some travel to Japan and the region as required in support of this close partnership and in support of key joint development committees. The role will report directly to the BMS ONO I-O Joint Development Team Leader ESSENTIAL LEADERSHIP BEHAVIORS Maintain a strong medical/scientific reputation across oncology Build and maintain strong relationships across BMS matrix, including general understanding of non-clinical components of development teams (regulatory, operations, etc.) Share specific clinical strategies with other clinical teams Study-specific clinical design and execution Manage communication with key stakeholders DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE Understanding of the fundamentals of clinical development (including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock) Clinical research experience (or related function, including those like Medical or Commercial who partner with clinical) Has a history of handling multiple, complex, studies in parallel Plans strategically - Anticipates, identifies and addresses issues in a proactive way and then partners on cross-functional teams to come up with solutions. Has a history of strong interactions with external stakeholders Performs as an individual contributor with some comfort working independently Identifies when an issue is present and begins to address Translates strategic input into concrete options. Participates or leads an above project work stream Peer mentors and contributes to onboarding of new talent Exhibits elements of BMS leadership capabilities
Bristol-Myers Squibb Company Cambridge, MA, USA
Mar 07, 2019
Full time
The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling activities. The candidate will be expected to effectively collaborate with colleagues in the Discovery Oncology, immunology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams and key stakeholders. Candidate requirements A B.S. with a minimum of 7 years, or an M.S. with a minimum of 5 years of industrial experience with strong scientific knowledge and research experience in in vivo pharmacology, cancer biology, immuno-oncology, or immunology is highly desirable. Extensive knowledge of preclinical drug development including demonstrated knowledge of independently designing, executing, and analyzing data from in vivo studies with tumor bearing mice is required. Experience with syngeneic tumor models is preferred; experience with GEMMs is a plus. Required skills include: tumor model development, tumor implantation, animal identification and randomization, dosing via IV, IP, SC, I-TUMOR and PO routes, tumor measurements by caliper, blood draws by tail vessel micro-sampling, cardiac puncture and tissue/tumor collection at necropsy including fixation, freezing and tissue disaggregation to support ex vivo analyses. Experience utilizing multi-color FACS to characterize tumor infiltrating lymphocytes is desirable. Proficiency in cell culture and ex vivo techniques such as qPCR, ELISA (MSD), or WB is required. Experience with surgical procedures to enable development of orthotopic tumor models and using ultrasound to monitor orthotopic tumor growth is desirable. Experience conducting in vivo pooled genetic screens is desirable. Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required. Ability to mentor junior scientists and colleagues on best practices in the laboratory would be highly valued. Attention to detail with excellent organizational and record keeping skills is a requirement. Ability to thrive as a member of a diverse and motivated team of researchers spanning across the Oncology Discovery group is a requirement. Responsibilities include Independently design and conduct mouse in vivo pharmacology experiments, including but not limited to model development, tumor implantation, animal identification and randomization, dosing via IV, IP, SC, I-TUMOR and PO routes, tumor measurements by caliper, weighing, health monitoring, tissue sampling by fine needle biopsy and core needle biopsy, peritoneal lavage, blood draws by retro-orbital, tail vessel micro-sampling, cardiac puncture and tissue/tumor collection at necropsy including fixation, freezing and tissue disaggregation to support ex vivo analyses. Mentor junior associates on best practices (in vivo and ex vivo). Establish complex orthotopic tumor models. Utilize ELISAs (MSD), qPCR, or WB to monitor biomarkers in harvested tissues. Contribute to the utilization of multi-color flow cytometry to profile the immune infiltrate in harvested mouse tissues. Accurately maintain proper scientific documentation associated with pharmacology studies in an electronic lab notebook. Effectively communicate and present summaries of research results to team members or to a multidisciplinary team of researchers. Work as a member of a diverse and motivated team of researchers spanning across the Oncology Discovery group and other line functions. Rotating weekend, holiday and off-hour on-site responsibilities to support BID/QD dosing will be expected of this position. This position is located in Cambridge, MA. There will be less than 10% travel.
Bristol-Myers Squibb Company Cambridge, MA, USA
Mar 07, 2019
Full time
The Research Scientist Biology will join the Oncology Resistance Biology group at Bristol-Myers Squibb in Cambridge, MA and support the preclinical drug discovery and development of early stage therapeutic targets at the intersection of tumor genetics and tumor immunobiology. The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling activities. The candidate will be expected to effectively collaborate with colleagues in the oncology, immunology, immuno-oncology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams and key stakeholders. Qualifications A B.S. with a minimum of 7 years, or an M.S. with a minimum of 5 years of industrial experience with strong scientific knowledge and research experience in cancer biology/cellular and molecular biology is required. Experience in immune-oncology research is a plus. Demonstrated independence in experimental design, execution, data analysis and troubleshooting is required. Knowledge of preclinical drug development including knowledge of designing assays and flowcharts to identify and optimize drug candidates is required. Hands on experience with a wide range of in-vitro cellular and biochemical assays such as cell culture, cell line engineering, western blotting, immunoprecipitation, ELISAs (MSD), reporter assays, and high content imaging Experience with multi-color FACS or ex vivo pharmacology (e.g. histoculture) is highly desirable. Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required. Ability to mentor more junior scientists and colleagues on best practices in the laboratory would be highly valued. Attention to detail with excellent organizational and record keeping skills is a requirement. Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required. This position is located in Cambridge, MA. There will be less than 10% travel.
Bristol-Myers Squibb Company Rico, CO 81332, USA
Mar 06, 2019
Full time
Summary: Accountable for the design, performance and documentation of validation studies for products manufactured at the pharmaceutical manufacturing sites. This includes the processes, formulation and equipment used in the manufacture of solid and Parenteral products and all related systems, utilities, and services needed to support the manufacturing activities. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Major Duties and Responsibilities: 1. Prepares well-documented protocols for all processes to be qualified/validated based on corporate guidelines, procedures, FDA Regulations, and Industry current practices. 2. Coordinates the validation activities with related departments (Engineering, Manufacturing, QC/QA, Technical groups) 3. Develops and controls detailed time and event schedules for all studies/projects assigned. 4. Performs qualification/validation studies as per established protocol. 5. Reports in an accurate and timely manner all the studies/project assigned in accordance with the designed protocol. 6. Evaluates process/equipment performance during the studies in order to determine acceptability, reproducibility, and control. 7. Provides timely and efficient technical support to user on qualified/validated systems/processes. 8. Maintains all documentation records in accordance with cGMP's, company policies and FDA regulations. 9. Maintains an understanding of the current technical and regulatory trends in the pharmaceutical industry. 10. Proposes and formalize alternatives for enhancement to validate a process. 11. Maintains validation programs in conformance with department standards and government/corporate regulation/specification. 12. Utilizes statistical tools and other techniques to assess performance of validation studies. 13. Assists management during FDA inspections by interacting with FDA/auditors during inspection or audits. 14. Provides annual revision of the validation programs covered in the validation Master Plan. 15. Update Operational procedure of equipment/system validated according to actual results. 16. Train impacted personnel by updated operational procedure. 17. Collaborates with internal /external clients as requested and or permitted by immediate supervisor. 18. Provides backup support to the section Associate Director during his/her absence and makes section decision as needed. Knowledge/Skill/Education: • Bachelor Degree in Pharmacy, Chemistry or Chemical / Mechanical Engineering or any other related Science field. • Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for Parenteral and biological dosage forms. • Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting. • Proficient knowledge of biopharmaceutical formulation processes, Parenteral filling and syringe filling processes. • Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations. • Detailed understanding of how Parenteral manufacturing processes are controlled and validated. • Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to technology transfer and scale-up activities. • Strong project management skills. • Proficient time management skills, planning and organization capabilities. • Proven ability to influence and work with people at different levels and departments. • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups. • Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management • Proven assessment, analytical and problem-solving skills. • Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish) • Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry. Cleaning validation for manufacturing equipment in-depth knowledge and experience is required
Bristol-Myers Squibb Company Cambridge, MA, USA
Mar 06, 2019
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. We seek an experienced, talented, highly motivated and detail-oriented Proteomics Research Scientist with proven track record to join the Proteomics group within the Discovery Research organization at BMS. This is a laboratory based position, reports directly to the Proteomics Principal Investigator and ultimately to the Head of Proteomics within the Genomics organization. The candidate is expected to work effectively in a highly collaborative matrixed environment, interfacing with oncology, cardiovascular, and fibrosis discovery to bring to bear proteomics techniques to tackle complex biological questions. The candidate needs to have a proven track record and experience in successfully applying proteomics to either discovery or translational space. Hands on laboratory experience in utilizing proteomics methodologies as well as contextual optimization methods to fit study needs is required. Experience with latest proteomics mass spectrometry techniques / workflows to characterize complex proteomes to enable translational and clinical research activities is absolutely necessary. Experience with effective utilization (including basic maintenance) of proteomics analytical instrumentation (latest generation, nano-chromatography and mass spectrometry) and associated data handling software interfaces is a must. Experience with proteome level post-translational modification analyses (e.g. glycosylation, acetylation/methylation) would be a plus but is not necessary. Experience or working knowledge of proteomics design of experiments, LC/MS proteomics data processing and subsequent data analyses is required. Experience with automation and laboratory instrument data management is desirable. Deep proficiency in applying classical protein biochemical techniques as well as updated proteomics techniques (protein fractionations, chromatography etc.) is absolutely necessary. Familiarity with basic cell culture techniques and standard molecular biology techniques is highly desirable. Additionally, experience with handling human as well as animal biomatrices (including tissues, plasma ...) is highly desirable. Overall, excellent lab skills and lab etiquette are crucial and required to be successful in this position. The candidate must have expertise with clearly drafting lab work practices and maintain regular scientific records in terms of laboratory notebooks. The candidate should be proficient with workplace software tools (word processing, excel, presentation etc.). Qualifications B.S. /M.S. in Biochemistry, Analytical Chemistry, Life Sciences, or related field including a minimum of 4 to 8 years of relevant proteomics experience. Scientific creativity, innovation and resilience are absolutely necessary to be successful in this position. A record of scientific productivity documented in peer reviewed journals is highly desirable. The candidate should have a strong interest in drug discovery research. The individual should possess ability to handle multiple projects, closely collaborate & matrix with scientists within the group and across Translational Medicine and Discovery organization. The candidate should have effective organization and presentation skills; be reliable, highly motivated, have strong interpersonal communication skills and embrace working in a team/matrix environment. The candidate should possess strong personal attributes of integrity, perseverance in face of challenges, and ability to tackle complex problems.
Bristol-Myers Squibb Company Newark, NJ, USA
Mar 03, 2019
Full time
Bristol-Myers Squibb is looking for a Senior Territory Business Manager for the Newark,, NJ territory in the MID-ATLANTIC District. Understands and applies knowledge of health care industry, trends, applicable laws and regulations, market conditions, and the managed health care environment into business plans and in daily execution of sales calls within compliance guidelines. Develops and implements territory plans that properly identify and prioritize activities to accomplish short and long term business plan goals. Demonstrates clear and thorough understanding of disease states, BMS products and relevant competitor products, including their mechanisms of action, indications, efficacy, safety, etc. Collaborates with territory matrix team on identifying opportunities and developing appropriate tactics and strategies. Builds and maintains strong professional relationships with physicians in private practice, medical group practices and or hospitals, office staffs and others in the patient care continuum. Fosters team effectiveness and accomplishment of shared goals by sharing knowledge, experience, and information. Drives market share growth and maximizes sales performance within the indicated use and for the approved patients. Infusions & injectable, the Buy and Bill office model and Medicare Part B Reimbursement is a significant plus . The successful candidate must have a bachelor's degree or equivalent with minimum of 3 years of Pharmaceutical Sales Representative experience.Drives market share growth and maximizes sales performance within the indicated use and for the approved patients. Demonstrated strong sales performance track record. Demonstrated understanding of the business drivers, dynamics, regulations and managed health care within the pharmaceutical industry. Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network. Effectively use active listening, probing and other selling skills to enhance communication, build and influence key customers. Demonstrated ability to analyze, develop and execute business plans. Demonstrated ability to work in matrix teams. Demonstrated track record of developing self to drive and enhance performance. As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of "Qualified Driver," as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver's license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company. Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate. In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies: Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning.
Bristol-Myers Squibb Company Nashville, TN, USA
Mar 03, 2019
Full time
The preference is that the successful candidates will live within their respective District geographies. The territory for the Tennessee Valley district includes: Alabama, Kentucky and Tennessee. Who you will work with The District Business Manager (DBM) role reports to an Orencia Regional Business Director and works with a team of Territory Business Managers (TBMs) to provide strong leadership, ensure flawless execution, build a winning culture, and deliver on sales expectations. In addition, you will be responsible to work with a dynamic matrix team to help address customer needs and ensure we deliver on our objective of demonstrating value to our customers. The primary responsibilities Mobilize a District of Territory Business Managers around the BMS mission and pledge, the business unit, and the Orencia brand vision and strategy. Provide input on sales organization issues, opportunities and direction and fulfill strategic brand and non-brand point responsibilities as assigned. Ensure superior execution of business unit and brand strategy within the District by translating strategy into District specific goals, objectives and business plans that take into account unique characteristics of the District, e.g., geography, payer landscape, customer mix, etc. Develop, review and modify the District business plan on a proactive basis. Interpret and integrate data to develop communication strategies to drive performance and productivity within the District. Identify and secure necessary resources and facilitate alignment with matrix team members to successfully execute the District business plan. Ensure execution of robust District and Territory-level business plans Explore and develop new relationships and effectively maintain existing relationships with key contacts and opinion leaders across the customer base, e.g., providers, healthcare systems, advocacy groups. Effectively lead and embrace change within the organization, serve as champion for change efforts and ensure understanding and alignment around changes. Manage the District's operational and brand product budget and ensure appropriate allocation of budget against identified priorities. Set specific and measurable objectives and track and analyze performance and productivity data against these measurements for District team. Meet or exceed sales goals utilizing approved materials and programs. Recruit, select and develop individuals with the talent necessary to achieve competitive superiority in the market. Hold yourself and the team accountable for business results and demonstration of the BMS BioPharma Behaviors. Serve as a role model for best-in-class Compliance and hold the District accountable for Compliance by ensuring all practices within the District are compliant with the BMS Compliance Code of Conduct, PhRMA Code, OIG Guidelines, PDMA Policies and Procedures and all other applicable laws, regulations, policies & procedures. Qualifications and Experience we look for in a candidate Minimum of 3 years of pharmaceutical field sales experience. Prior specialty sales experience, including buy and bill, and other pharmaceutical functional experience is preferred. Examples: sales management, operations, sales learning, finance, marketing, market access, etc. Bachelors Degree or equivalent. Working knowledge of the rheumatoid arthritis (RA) biologic market, geographic conditions, customer base, etc. Understanding of environmental and industry trends, and impact on business. Experience building and leading high performance teams. Participation in the development and implementation of strategy on a geographic or product basis. Ability to travel up to 75-80% of the time including periodic travel to our NJ headquarters.
Bristol-Myers Squibb Company Oakland, CA, USA
Mar 03, 2019
Full time
This position is for Eliquis, Specialty Retail Sales Representative located in Oakland, Ca. Summary Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines. Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals. An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum. Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time. Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers. Excellent communication skills- verbal and written- including the ability to present to groups. Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners. Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types. Possess a high level of ethics and integrity. Adhere to all applicable laws, regulations, and BMS policies. Requirements Bachelor's degree or equivalent is required. Minimum of 5 years of sales experience is preferred. Demonstrated success in medical profession is advantageous. A strong customer focus and analytical skills to identify and prioritize business opportunities is required. Proven track record in delivering results and developing innovative approaches in evolving markets. Previous new product or concept launch experience desired. Ability to learn, apply, and grow disease state knowledge is required. Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings. Technical aptitude to learn and apply new technologies to manage a territory is required. Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate. In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies: Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning. As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of "Qualified Driver," as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver's license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.
Bristol-Myers Squibb Company Princeton, NJ, USA
Mar 02, 2019
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. The Discovery Chemistry team is looking for a hands-on analytical scientist to provide separation support for discovery of synthetic drug molecules in a team environment. The position will involve performing chromatographic separations for analysis and purification of synthetic molecules in a drug discovery environment, including the use of a variety of chromatographic and detection methods. Primary responsibilities will include: Performing chromatographic method development and analytical separation using HPLC, SFC, CE and GC, including maintenance and utilization of sophisticated parallel SFC and HPLC systems from a variety of vendors including Agilent, Shimadzu, and Waters. Performing preparative scale separation of challenging drug molecules and metabolites using preparative-HPLC or SFC with UV and MS detectors from a variety of vendors including Agilent, Shimadzu, and Waters. Use and maintain specialized separation and detection instruments that including2D UPLC/ToF MS; HPLC/Chemiluminescence Nitrogen Detector (CLND), UPLC/FLD, SEC/MALS/RI, and parallel SFC/UV/CD. In addition, the chosen candidate will assist senior scientists to develop and implement innovative chromatographic and spectroscopic solutions for non-routine problems such as chiral interconversion kinetics and thermodynamics, biomarker assay development, and other special projects. Requirements: The candidate will have a Ph.D. in Analytical Chemistry or a related field with 1-3 years demonstrated experience in relevant biopharmaceutical applications. The following qualifications are required or preferred: Hands on experience in separation science is required, including both analysis and purification using HPLC and/or SFC with a variety of detection methods (UV and MS required). Familiarity with chromatography instrument hardware and software from major vendors (Agilent, Waters and/or Shimadzu) with skills at diagnosis and correction of instrumental and methodological problems. Familiarity with the concepts of modern chromatography, including method development, mobile and stationary phase selection, method optimization, and data interpretation is required. Demonstrated ability to succeed in a highly matrixed multitasking environment, including time management and prioritization is required. Evidence of using strong written and oral communication skills to effectively interface with customers and collaborators with diverse areas of expertise is required. Hands-on experience in maintaining, automating and customizing chromatographic and spectroscopic instrumentation is desirable but not required. Skills in computer programming, modeling and statistical analysis are desirable but not required.
Bristol-Myers Squibb Company New Brunswick, NJ, USA
Mar 01, 2019
Full time
Job description Advice department on the design of testing laboratory processes and activities for enhanced compliance. Accelerate implementation of practice changes in testing laboratories brought by procedure revisions and change management. Apply GMP regulations in an environment that bridges development and commercial manufacturing of active ingredient and medicinal products. Function as expert in laboratory procedures through understanding of their application and authoring. Conduct laboratory investigations and design corrective/preventive actions and grow the laboratory investigator community through measurement. Conduct efforts that build investigation expertise. Drive audit readiness of GMP laboratories. Perform as a department leader in support of the Quality Management System and Quality Risk Management program. Sustain partnership between the GMP laboratories, the Quality Unit and other laboratory collaborators. Desired Experience Required: BS or MS in science, engineering or related field with 5+ years' experience GMP laboratories or QA function. Demonstrated ability to influence across departments and sites. Experienced in authoring and revision of procedures Experience with periodic review, change management, supporting audits, and quality management system such as TrackWise. Experience in commercial pharma/biologics manufacturing environment preferred. Experience with tools for root cause identification and best practices in development of corrective actions. Ideal Candidate will also have: Experience with risk assessments associated with data integrity and/or process analytical technology. Advanced user of with Microsoft applications and experience with Share Point Online. Six Sigma certification or analytics software experience is a plus.
Bristol-Myers Squibb Company Syracuse, NY, USA
Mar 01, 2019
Full time
The Plant Engineering team is responsible for the compliant operation of GMP critical utilities (such as cleanroom HVAC, high-purity water systems, and process gases) and the reliable operation of essential support utilities (such as electricity, glycol, compressed air, and process waste). This group executes projects to improve the safety, efficiency, reliability, and compliance of these systems. They oversee maintenance activities, coordinate system shutdowns, and lead investigations related to these systems. Members of this team serve as subject matter experts (SMEs) for these systems on project teams and during regulatory inspections. The members of this team are expected to cross-train on facility systems, but each individual will maintain specialized expertise. The Associate Plant Engineer role is an entry-level plant engineering position that provides an early-career development opportunity to make joint and independent contributions to the plant engineering group. This role will support more senior plant engineers as required and manage independent responsibilities (projects, system ownership, investigations, etc.). The incumbent is expected to become more independent as he/she learns the systems and responsibilities of the plant engineering group. Responsibilities: • Work in collaboration with more senior plant engineers and independently to ensure reliable, compliant operation of plant systems • Represent plant engineering at tiered meetings and communicate system status at tiered meetings • Issue or contribute to safety permits and job hazard analyses (JHAs) to ensure the safe execution of projects or maintenance activities. • Manage engineering projects to improve plant utility systems. Seek out and apply novel engineering approaches. • Coordinate projects and maintenance activities with operations in order to minimize disruption. • Provide technical guidance for maintenance technicians, outside service providers, and operations users. • Engage with Facilities & Engineering (F&E), Global Engineering, and external resources to engineer solutions. • Review and approve drawings and other technical documentation to ensure that it remains current. • Ensure compliance of GMP critical utilities with GMPs, industry best practices, and BMS directives. • Investigate adverse trends, and implement corrective actions. • Create or contribute to quality plans that ensure orderly service interruptions and smooth return to service. • Collaborate with other functions such as quality assurance or safety to resolve compliance issues. • Remain informed about the current industry practices and guidelines for critical utilities. • Respond to unplanned outages in order to minimize disruption to manufacturing operations. • Ensure inspection-readiness of key systems. Develop responses and action plans to correct any deficiencies. Serve as back-up SME as required. • Leverage appropriate resources from our site integrated facilities management (IFM) provider. • Identify continuous improvement, energy conservation, and cost savings opportunities. • Apply modern reliability concepts to ensure effective maintenance and prevent failures. • Maintain and revise standard operating procedures (SOPs) governing system operation and maintenance. Train in-house technicians and contractors as required. Qualifications: • Bachelor of science degree in Engineering (chemical/mechanical) with strong academic credentials. • 0-3 years experience in an engineering role • Some knowledge of pharmaceutical utility operation, cleanrooms, and building systems. • Experience with (or ability to learn) Maximo CMMS, Ariba purchasing, and SAP cost center functions. • Demonstrated ability to work across organizational boundaries to resolve a range of technical and compliance issues. • Experience safely managing multiple projects and balancing priorities. • Strong analytical and problem solving skills, especially as applied in a team environment. • Willingness to provide on-call, off-hours support as needed to assist with planned activities or respond to unplanned problems. • Understanding of (or ability to quickly learn) applicable regulations (GMP, OSHA, DEC, etc.). Familiarity with quality systems governing GMP utilities (change control, SOPs, investigations, CAPAs). • Interest in modern maintenance management and reliability concepts. • Ability to compose sound technical and compliance documents, including thorough investigations, meaningful corrective action plans, and justifiable change controls. • Ability to articulate complex technical issues and communicate in a variety of forums to stakeholders and site leadership. • Experience working in a GMP environment is a plus.
Bristol-Myers Squibb Company Syracuse, NY, USA
Feb 28, 2019
Full time
Plant Engineer (Pharm Water Systems) RESPONSIBILITIES • This plant engineering position will have primary responsibility for pharmaceutical water systems, including water for injection (WFI), reverse osmosis (RO), de-ionized water systems (DI), and clean steam. • Issue or contribute to safety permits and job hazard analyses (JHAs) to ensure the safe execution of projects or maintenance activities. • Manage engineering projects to improve plant utility systems. Seek out and apply novel engineering approaches. • Coordinate projects and maintenance activities with operations in order to minimize disruption. • Provide technical guidance for maintenance technicians, outside service providers, and operations users. • Engage with Facilities & Engineering (F&E), Global Engineering, and external resources to engineer solutions. • Review and approve drawings and other technical documentation to ensure that it remains current. • Ensure compliance of GMP critical utilities with GMPs, industry best practices, and BMS directives. • Investigate adverse trends, and implement corrective actions. • Create or contribute to quality plans that ensure orderly service interruptions and smooth return to service. • Collaborate with other functions such as quality assurance or safety to resolve compliance issues. • Remain informed about the current industry practices and guidelines for critical utilities. • Respond to unplanned outages in order to minimize disruption to manufacturing operations. • Serve as a site SME for critical utility systems and interact with regulatory authorities or internal auditors. Ensure inspection-readiness of key systems. Develop responses and action plans to correct any deficiencies. • Leverage appropriate resources from our site integrated facilities management (IFM) provider. • Identify continuous improvement, energy conservation, and cost savings opportunities. • Apply modern reliability concepts to ensure effective maintenance and prevent failures. • Maintain and revise standard operating procedures (SOPs) governing system operation and maintenance. Train in-house technicians and contractors as required. QUALIFICATIONS • Bachelor of science degree in Engineering. • Knowledge of pharmaceutical utility operation, cleanrooms, and building systems. • Experience with (or ability to learn) Maximo CMMS, Ariba purchasing, and SAP cost center functions. • Demonstrated ability to work across organizational boundaries to resolve a range of technical and compliance issues. • Strong technical knowledge in a focus area such as pharmaceutical water systems, HVAC, or electrical engineering. • Experience safely managing multiple projects and balancing priorities. • Strong analytical and problem solving skills, especially as applied in a team environment. • Willingness to provide on-call, off-hours support as needed to assist with planned activities or respond to unplanned problems. • Understanding of applicable regulations (GMP, OSHA, DEC, etc.). Familiarity with quality systems governing GMP utilities (change control, SOPs, investigations, CAPAs). • Familiarity with modern maintenance management and reliability concepts. • Ability to compose sound technical and compliance documents, including thorough investigations, meaningful corrective action plans, and justifiable change controls. • Ability to articulate complex technical issues and communicate in a variety of forums to stakeholders and site leadership. • Experience working in a GMP environment is a plus.