Process Development Senior Principal Scientist
About The Position
Amgen is seeking a Senior Principal Scientist in its Process Development organization, within the Drug Product Technologies unit. The role leads commercial drug product programs as a Drug Product Team Leader (DPTL) and leads a scientific team supporting the advancement of commercial drug product programs. DPTLs serve as the single point of accountability for technical activities across individual drug product programs, including formulation, aseptic drug product process design and validation, combination product development, process improvements, lifecycle changes, regulatory submissions, and annual product reviews. The position leads the planning, design, execution, and documentation of laboratory studies for drug product design, formulation, and process development supporting commercialization and lifecycle management of parenteral presentations. It also leads late-stage drug product process development and technology transfer, and supports clinical and commercial fill/finish operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments. The Senior Principal Scientist drives continuous improvement through technological innovation and first-principles process engineering; participates in global, cross-functional teams; authors and reviews technical and regulatory documentation; and communicates program progress and needs to management. The role uses advanced information systems, historical data, large data sets, and statistical analysis to improve drug product design. Domestic and international travel may be required up to 10% of the time.
Requirements
- Doctorate degree (PhD, PharmD, or MD, and relevant postdoctoral experience where applicable) plus 3 years of engineering or science experience; or a master’s degree plus 6 years of engineering or science experience; or a bachelor’s degree plus 8 years of engineering or science experience.
- Ability to travel domestically and internationally up to 10% of the time.
Nice To Haves
- Advanced degree in Pharmaceutics, Biotechnology, Engineering, or a related discipline, with industry experience in pharmaceuticals or biotechnology.
- Demonstrated knowledge of drug product commercialization and integrated combination product development, with hands-on end-to-end development experience for liquid, lyophilized, and/or oral solid dosage drug products in various presentations.
- Demonstrated experience in process transfers, control strategy, authoring marketing authorization submissions, developing robust responses to regulatory questions, supporting validation activities, and supporting pre-approval inspections at commercial sites.
- Understanding of the physical and chemical stability of proteins and how process-related stress affects product quality, specifically the impact of freezing and drying on short- and long-term stability.
- Strong knowledge of developing processes with single-use manufacturing equipment.
- Aseptic processing experience and familiarity with cGMPs and ICH guidelines.
- Experience with elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control, and statistical design and analysis of experiments.
- Strong problem-solving and effective cross-functional communication skills.
- Proven ability to learn and act on dynamic information rapidly.
- Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change and efficiency and build strong cross-functional relationships.
Responsibilities
- Serve as a leader on Drug Product Commercialization Teams, planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development for commercialization and lifecycle management of parenteral presentations.
- Lead a team of scientists focused on late-stage drug product process development and technology transfer, coaching staff with an emphasis on people-centered leadership.
- Support clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes or improvements.
- Drive continuous improvement in drug product development through technological innovation and application of first principles in process engineering.
- Participate in and lead global cross-functional teams to influence and drive change and efficiency and foster strong relationships in a highly matrixed environment.
- Author and review guideline documents, technical protocols and reports, product impact assessments, and regulatory submissions; develop responses to regulatory questions.
- Deliver progress reports and presentations to keep management informed and engaged on program status, progress, and future program and functional needs.
- Use advanced information systems to improve drug product design through faster data availability, historical information, large data-set analysis, and statistical analysis.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and savings plans with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
