The Upstream Process Development team at BioMarin Pharmaceutical is seeking a Principal Scientist to lead and grow a 5+ member team. Reporting to the Head of Upstream Process Development, the Principal Scientist will be a senior leader in the Drug Substance Technologies division of Technical Development, and partner with key colleagues in Manufacturing Sciences and Technologies, Quality, and Manufacturing.
They will coordinate goals, support resourcing, ensure input with participating groups inside and out of BioMarin, and lead research projects through their various stages of development. This individual will be responsible for overseeing the activities and professional development of a group of junior scientists and research associates as they develop, characterize, and transfer upstream biomanufacturing processes for our biologics pipeline programs from preclinical studies through commercialization. Activities of the team include design and execution of experiments in the laboratory, utilizing and refining bench-top and pilot scale bioreactor process models, and purification or analytics of intermediate samples to assess performance. The team leads or participates in process transfer, monitoring, and support efforts to one or more manufacturing sites. The team also expands technical capabilities through evaluation and development of new manufacturing processes, equipment, monitoring instrumentation, and data analytics in conjunction with partners across the organization.
Experience with clinical process development phases, cGMP operations, and regulatory expectations is essential for success. Bioreactor scale-up and development experience is strongly desired, including understanding of the underlying engineering principles. This individual must be competent with design of experiments, statistical tools for analysis and interpretation of data, and electronic data management systems. The ideal candidate will also have familiarity with different biologics modalities and large-scale production systems for manufacture of therapeutic proteins and gene therapy vectors.
- Leading team of scientist and RAs for upstream development activities; support coaching and mentoring
- Oversee experimental, tech transfer, and manufacturing support activities devoted to advancing clinical stage CMC programs
- Author or review relevant CMC-related sections of regulatory filings and responses to health authority requests
- Participate in efforts to define, manage, and/or complete innovation projects that advance technical capabilities, refine & establish platform manufacturing processes
- Track team progress against project timelines, generate regular status updates and communicate progress, resourcing needs and issues to leadership
- Foster strong collaborations with partners within Technical Development (Analytical Sciences, Chemical, Device & Drug Product Technologies, CMC Integration), Quality, and Manufacturing Sciences
- Represent Upstream Process Development on cross-functional initiatives, e.g. establishing strategies & best practices, providing feedback to partners
- Design, setup, and oversee evaluation of new process or analytical equipment
- Generate documentation for experimental reports to support technology transfer and regulatory filings (development and technical report writing).
- Attend scientific meetings and training courses to gather knowledge on best practices in industry
Ph.D. in Chemical/Bioengineering, Biochemistry, Biology, or other related scientific discipline, plus 10+ years relevant industry experience; or M.S. with 15+ years, or B.S. with 18+ years.
- Experience with biologics upstream process development and product lifecycle through at least Phase 3 GMP manufacturing; up through product approval and post-approval lifecycle studies preferred
- Successful management of scientists/research associates, with focus on professional development for employee and fit to organizational needs
- Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
- Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment
- Strong communication skills to articulate activities of team through oral presentations
- Clear technical writing and editing to author or oversee generation of technical reports
- Expertise with variety of cell culture processing platforms and production systems (mammalian, insect, yeast, bacterial)
- Bioreactor scale-up and process characterization and risk assessment experience necessary
- Ability to perform statistical design of experiments (DoE), data analysis and interpret and present results
- Must be proactive and able to design experimental plans independently
- Viral vector production/processing (AAV or otherwise) at pilot scale or beyond
- Authoring of regulatory submissions (IND/IMPD/BLA/MAA) and responses to health authority requests for information
- Experience with establishing or refining production platforms
WORK ENVIRONMENT / PHYSICAL DEMANDS
The employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; biohazardous, toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually modest. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Employee may be asked to move or lift heavy objects up to 50 lb with assistance.
The employee may utilize biosafety cabinets and incubators or operate benchtop or pilot-scale bioprocessing equipment and control skids for operations with bioreactors, chromatography, tangential flow filtration, depth filtration, and centrifugation. Analytical equipment for measurement of cellular density and viability, metabolites, protein and nucleic acids may all be utilized.
Will report to Head of Upstream Process Development and interface with internal department leaders and external partners from Quality, Regulatory, Technical Development, and Research.
Will supervise, mentor, and manage a team of Scientists and Research Associates.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.