Associate Director/Director Biologics Upstream Process Development

Alkermes Waltham , MA 02154

Posted 12 months ago

Position: Associate Director/Director Biologics Upstream Process Development

Hiring Manager: Natraj Ram

Company Overview

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and oncology. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and research and manufacturing facilities in Athlone, Ireland and Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

Director Biologics Upstream Process Development

This position is responsible for leading the Biologics Upstream Process Development Team in taking Alkermes' biologics candidates from discovery through process development, scale-up, optimization, process characterization, tech transfer, clinical production, validation and commercial launch. The Team will also work with external development and manufacturing organizations. The Biologics Process Development labs will be located in Waltham, MA with scale-up capabilities up to 200 L scale.

This position will lead a group responsible for:

  • Support clone selection and cell banking

  • Media and feed development and optimization

  • Upstream process development, scale up, and optimization

  • Process Characterization and Control Strategy Development

  • Tech transfer to CMO/CDMOs

  • Support validation and commercial launch

  • 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 Engineering with 15+ years technical and management experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes.

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

  • < />

Detailed understanding of science and engineering principles along with up to date knowledge ofupstream 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

  • < />

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.

#LI-JW1


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Associate Director/Director Biologics Upstream Process Development

Alkermes