Principal Engineer/Research Fellow, Biologics Upstream Process Development at Alkermes, Inc. in Waltham, Massachusetts

Job Description:

Principal Engineer/Research Fellow, Biologics Upstream Process Development

Position Summary:

This position will manage the development of novel active pharmaceutical ingredients (API) within the Alkermes biologics pipeline from the early Process Development stage through GMP production (Clinical Phase 1-3). The candidate will be responsible for the internal upstream lab for biologics process development and will provide technical oversight for associated activities occurring at external contract development and manufacturing organizations (CDMOs).

A solid background in biological engineering is required with a focus on bioreactor engineering, scale-up and technology transfer. The successful candidate will have several years of experience working with mammalian processes in glass bioreactors as well as single-use technology. Experience with AMBR-15 miniature bioreactor systems is highly desirable. The incumbent is expected to integrate Design of Experiments (DoE) principles, implement experimental design with a focus on process understanding and robustness, interpret data, participate in cross-functional teams, write technical reports, and author sections for regulatory submissions (IND, IMPD, BLA).

This position has the potential to develop into a group leader for Upstream Process Development. The candidate should have strong communication and interpersonal skills, be able to multi-task, and have a commitment to continuous learning. Prior managerial experience is a plus.

The appointment will be at the level of Principal Engineer, or Research Fellow, commensurate with experience. The position is expected to spend ~60-70% of their time in the wet lab.

Responsibilities include but are not limited to:

• Develop robust biological process platforms, enabling successful transition of assets from Discovery Biology into Process Development and provide in-depth expertise in all upstream related activities


• Day-to-day execution of bioreactor experiments at various scales (AMBR-15, 2L SUB, 10L glass, 50L SUB)


• Develop fed-batch processes and feed strategies


• Technical oversight of upstream development activities at CDMOs


• Support technology transfer to and production at CDMOs


• Implement harvest methodologies (depth filtration, sterile filtration)


• Implement scale-up strategies for bioreactor operations internally and at CDMOs with a focus on process understanding, identification of critical process parameters, and process optimization


• Function as internal lead for Upstream Process Characterization


• Keep abreast with new technologies in the field, and identify, implement, and deploy novel technologies where aligned with business needs


• Collaborate within cross-functional teams, including Discovery Biology, Analytical Development, Quality Assurance, Technical Operations and Validation


• Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11


• Write technical reports and deliver presentations to technical, CMC and broader project groups


• Develop process control strategy for clinical production and PPQ lots


• Author & review CMC sections of regulatory filing documents

Principal Basic Requirements:

• PhD in Biological Engineering, or Chemical Engineering with >8+ years of relevant experience and proven publication record, or


• MS in Biological or Chemical Engineering with >15+ years of experience

Research Fellow Basic Requirements:

• PhD in Biological Engineering, or Chemical Engineering with >12+ years of relevant experience and proven publication record, or


• MS in Biological or Chemical Engineering with >20+ years of experience

Preferred Requirements:

• Excellent written and oral communication


• Experience with stirred tank bioreactors for mammalian culture processes is a must


• Hands-on experience in designing, optimizing, and executing novel bioprocesses in pilot labs or commercial plants


• Proven ability to apply scientific principles to design, execute, and interpret experiments


• Experience with statistical design of experiments (DoE)


• Team player with good interpersonal skills

Additional Desired Knowledge/Skills:

• Tech transfer experience


• Process Characterization experience


• Experience with process development for continuous upstream manufacturing/intensified fed-batch production


• PAT and process monitoring experience


• Pharmaceutical cGMP manufacturing experience


• Quality by Design experience

Personal Attributes Needed:

• Motivated self-starter


• Positive, adaptable, can-do attitude


• Ability to work independently


• Ability to travel (15%, for conferences and CDMO visits/person-in-plant)

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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Experience Level:
Mid-Senior Level

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