At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

This position is in the Biologics GxP Raw Materials Group that maintains a highly versatile, analytical method development and GMP testing laboratory within the Product Development division at the Bristol Myers Squibb New Brunswick, NJ site. The team is seeking a hardworking, results-focused analytical chemist to lead global project teams and manage lab personnel in support of biologics pharmaceutical programs to bring a world-class R&D portfolio to market. The position will require strong inter-personal skills, the ability to lead individuals as well as matrix teams, and an advanced technical expertise in analytical method development, validation, transfers and testing for raw materials used in the manufacturing of clinical Biologic drug substances and drug products. This position will have multiple lab analysts as direct reports and will itself report directly to a Senior Manager within the GxP Raw Materials Group of the Analytical Strategy & Operations (ASO) Biologics department.

DUTIES & RESPONSIBILITIES:

Essential Duties and Responsibilities include, but are not limited to, the following:

• Directly manage a group of lab analysts tasked with the responsibility of developing phase-appropriate, robust, and reproducible analytical methods for use in a GMP clinical laboratory. As the manager, the primary responsibility in this aspect is directing and contributing to the study design for laboratory research, investigations, and execution of protocol related activities.
• Responsible for establishing milestones and directing the development of goals and objectives for direct reports. Includes preparing promotion and compensation proposals during year end evaluations.
• Demonstrate advanced knowledge of principles, concepts, and methodologies appliable to the development of phase-appropriate, robust, and reproducible analytical methods for use in a GMP clinical and commercial laboratories.
• Demonstrate the ability to independently develop test methods for and execute a wide range of analytical techniques. Applicable instrumentation and test methods include but are not limited to vibrational (IR, NIR, Raman) and UV-Vis spectroscopies, HPLC, Karl Fischer, polarimetry, color and appearance (physical description testing), pH measurements, compendial methods, and wet chemistry analytical techniques.
• Serve as group’s main project manager and primary contact on global matrix teams with the objective of delivering complete and thorough analytical work packages to manufacturing teams and QC laboratories. Key stakeholders from the global QC network include QC testing labs, Materials Science and Technology, Process Development, Microbiology, and Quality Assurance.
• Plans and directs the development of Master Transfer Plans to align deliverables towards analytical method qualifications, validations, and transfers with overall project timelines. The Transfer Plans direct the execution of laboratory protocol related studies and investigations. Contribute to study design and the authoring of analytical methods, specifications, protocols, and reports.
• Provide high-level technical leadership to the QC laboratories, including the development and provision of training courses on methods and instrumentation, leading and/or contributing to investigations that occur during validation/transfer activities, as well as release testing.
• Influence tactical and strategic decisions and lead initiatives related to continuous improvement or development of new approaches to address method and technological improvements and advancements.
• Oversee method lifecycle to contribute to sustained, long term raw material release capabilities at global biologic manufacturing sites.
• Mentor and guide junior analysts in analytical method development, validation, and transfer execution.
• Maintain clear, complete, accurate and GMP-compliant documentation for executed experiments and investigational reports.
• Proactively provide clear, timely communication of potential issues to management.
• Organize and present data for internal and external scientific meetings.

Professional Qualifications:

• The candidate must have a B.S. or equivalent with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent with at least eight (8) years industry experience, or M.S. in similar fields of study with at least six (6) years industry experience.
• At least five (5) years of experience in a GMP analytical laboratory environment is strongly preferred.
• The ability to exhibit a thorough understanding of cGMP/GLP and GDPs practices and EHS requirements is essential.
• Compliance with all applicable SOPs, internal ADT requirements, and external regulations is a must.
• Proficient knowledge of the drug development processes and broad expertise/experience in scientific/technical writing.
• Strong written and oral communication skills, exhibiting the ability to lead internal and cross-functional teams.
• The candidate must be able to deliver when working under assigned timelines and demonstrate good communication skills, particularly in documentation of data and writing reports and methods. Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.
• Expertise in MS Office applications, in particular MS Word and Excel, is required.
• Familiarity with electronic documentation systems (e.g., Qumas, Infinity, Syncade-DCA) for routing method development and investigational documentation is a plus.
• Experience in use of scientific reporting applications and ELN software, e.g., VelQuest, Symyx and LIMS, is preferred.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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