Principal Process Scientist/Engineer – Technology Transfer, Commercial Operations Support (R1553391-en-us)
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 the principle subject matter expert and process owner for the end to end manufacturing process for liquids and lyophilized parenteral products at Bristol Myers Squibb Phoenix. Ensures processes are designed and validated per applicable cGMPs, site procedures, and that processes are defined consistent with regulatory filings. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review of key CMC submissions, along with setting relevant standards and procedures.
This position will report into the Associate Director of Manufacturing Technology, Parenteral MS&T and is located in Phoenix, Arizona USA.
- Leads parenteral technology transfer projects for key lifecycle biologic parenteral products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.
- Development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
- Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
- Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental and/or authoring plans and/or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes.
- Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage. Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process.
- Representative on global supply strategy groups/site forums and to relevant stakeholders across the company.
- Leads, motivates, mentors, and develops team members to meet and exceed plant and company goals and objectives.
- Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities.
- Responsible to review and co-author key CMC sections.
- Requires approximately ~10% travel.
- Bachelor’s degree in Pharmacy, Biochemistry, Chemical Engineering or related Pharmaceutical sciences.
- Seven (7) years of directly related experience in Technical Services work within the pharmaceutical industry.
- Three (3) years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.
- Subject matter expert in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology, lyophilization, pre-filled syringe operations. Strong knowledge of global regulatory requirements related to the design and control of these processes.
- Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment.
- Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes.
- Strong oral and written communication skills.
- Ability to work within and lead cross-functional technical teams.
- Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
- Strong understanding of project management systems and tools is preferred.
- Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
- Ability to work in a fast paced, complex and changing environment.
- Excellent analytical, technical and strategic thinking skills and experiences.
- Demonstrated management, interpersonal and teamwork skills. Strong mentor, with excellent people development skills and track record.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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