Principal Scientist, PMS&T DP Development To Launch

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.

Summary:

You will provide technical leadership and have technical accountability for oral solid dosage (OSD) drug products transitioning from development to commercial launch. This includes participating in development teams for late-phase assets, commercial site selection, design and evaluate tech transfer studies, generation and execution of process performance qualification (PPQ) studies, and writing/reviewing important sections of regulatory dossiers.

• Work with the drug product team and manufacturing site technical leads to develop and communicate a tech transfer plan
• Serve as a technical expert in at least one relevant drug product manufacturing unit operation
• Act as the technical lead and project lead in tech transfer or other technical projects
• Ensure a high level of current technical knowledge is maintained within the MS&T group
• Provide leadership support and technical consultation to Commercial DP PMS&T DtL Lead
• Lead teams of MS&T Managers where required

Responsibilities:

Maintain technical leadership in manufacturing sciences in the areas of raw material characterization, formulation science, oral solid dosage processing, and other relevant drug product manufacturing technologies. Serve as the DP Pharma Manufacturing Science & Technology (PMS&T) representative on OSD drug product development to launch teams directing all tech transfer-related activities from and to all Bristol Myers Squibb and CMO manufacturing sites. Participate in lead sourcing due diligence, process fit/gap assessment between sending and receiving sites, tech transfer planning, setting specifications, creating robustness space, development risk assessments, writing sections for regulatory filings, and process and cleaning validation strategies. Provide on-site support for tech transfer and PPQ activities.

Collaborate with API teams to align on requirements to ensure delivery of a robust DP manufacturing process. Perform risk assessments to evaluate the probability and impact of risks. Provide input and maintain the product risk registers, and establish mitigation strategies to reduce or eliminate risk. Ensure QbD standards are followed during development and tech transfer. Make certain key and critical process parameters are identified and appropriate robustness monitoring programs and controls are in place.

Monitor DP performance with respect to changes in material properties or processes. Initiate and assess change controls associated with introducing new products to the site and changes associated with the process after PPQ is complete. Provide input as a technical leader on manufacturing processes and applicable technology platforms to other teams. As needed, lead or support significant technical investigations at manufacturing sites. Provide technical expertise in troubleshooting product/process issues.

Education/Skills

• Bachelor’s Degree in Industrial Pharmacy or Engineering (Chemical, Electrical, or Mechanical) with a minimum of eight (8) years of directly related experience in a Technical Services function within the pharmaceutical industry including strong proven work experience in pharmaceutical drug product technology transfers, process development, and technical support.
• Candidates with a Master’s or degree in Pharmacy or Engineering will be considered with four to six (4 – 6) years of directly related experience in a Technical Services function within the Pharmaceutical industry including strong proven work experience.

• Requires advanced knowledge of the standards and concepts applicable to a wide range of work in oral solid dosage processing including the areas of formulation development, tech transfer, commercial manufacturing, and unit operations
• Designs complex technical projects or investigations interprets diverse data and results, recommends next steps
• Leads multiple projects of moderate or high complexity within or across departments, and leads complex multi-site/function investigations if applicable
• Makes decisions that frequently require developing new options to Decisions impact the ability of a workgroup/team or department to accomplish its goals and meet the needs of the team
• Regularly adapts standard methods and techniques. Plays a significant role in continuous improvement efforts within a department/function
• Highly proficient in writing formal reports/documents, technical presentations, articles for publication, and scientific publications or patents
• Actively mentors others to promote the growth of less experienced scientists. Emerging as a functional leader who influences culture and values
• Complete knowledge of global regulatory requirements related to the design and control of pharmaceutical manufacturing processes
• Detailed knowledge of OSD drug product process validation and cleaning validation
• Experience in working with OSD drug product continuous manufacturing and spray dried dispersion
• Experienced with the use of statistical software to design DOEs and analyze process-related data

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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