Director/Research Fellow, Biologics Process Development

Alkermes Waltham , MA 02154

Posted 2 months ago

Director/Research Fellow - Biologics Process Development

This position is responsible for leading and coordinating Biologics Process Development activities for Drug Substance in taking Alkermes' biologics candidates from discovery through process development, scale-up, optimization, process characterization, tech transfer, clinical production and validation. The role will also work with external development and manufacturing organizations. The position will be located in Waltham, MA and will require travel to Alkermes sites and the CDMO on a regular basis.

This position will be responsible for:

  • Lead and coordinate all aspects of Drug Substance activities, with ability to provide in-depth expertise in upstream related activities leading up to BLA submission, as required

  • Process Development, Process Characterization and Control Strategy Development

  • Tech transfer to CMO/CDMOs

  • Technical support to CMOs for deviations and investigations

  • Qualification of new vendors and CMO/CDMOs

  • Authoring and reviewing technical reports and relevant regulatory submissions

  • Supporting the Regulatory group in responding to agency questions

  • In-depth knowledge in GMP systems, sterile processing, and US/EU requirements

  • Manufacturing tox and clinical supplies

  • Working closely with Biologics Discovery, CMC teams, and Technical Operations to ensure product success

Education / Experience

Qualified candidates should have a PhD in Biochemistry/Chemical Engineering or related disciplines with 10+ years technical experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes. Experience with CMC/Functional Leadership with programs that have been progressed to BLA is desired. Expertise in advanced experimental design and statistical analysis is desired.

Skills / Attributes Needed

  • Leadership & Management

  • Strong leadership qualities (integrity, honesty, empathy, confidence, inspiration, commitment, passion, good communicator, decisive, accountable, delegates, empowers, creative/innovative)

  • A collaborative, passionate, empathic personality with excellent interpersonal skills that positively influences the group culture and team dynamics

  • Active participation in team environments and freely offers constructive opinions and suggestions with the expectation they will support their teammates to assure project success

  • Ability to lead and influence technical teams and mentor less experienced scientists and engineers

  • Foster a culture of continuous improvement and operation excellence

  • Technical

  • Detailed understanding of science and engineering principles along with up to date knowledge of upstream biologics processing technology and regulatory expectations

  • Experience with developing process for novel modalities and non-antibody recombinant protein products in mammalian cell culture

  • Experience in upstream biologics process development, scale-up and optimization along with a broad understanding of analytical technologies that can help enhance process understanding

  • Energized solving technical problems, learning, creative thinking, and critical analysis and is committed to taking action and getting results

  • Demonstrated knowledge and experience in designing experiments (DOE) and establishing operating ranges as well as establishing control strategies

  • Communication

  • Excellent verbal, writing, and presentation skills with the ability to present concepts and results in a convincing, confident manor and to adjust presentation depth to meet needs of the intended audience

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.


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Director/Research Fellow, Biologics Process Development