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Contractor, Process Engineer, Manufacturing Sciences

4 months ago

Waltham, United States Stratacuity: Proven Scientific Placement Full time

Location: Waltham, MA (Hybrid)

Science: Antibody Drug Conjugates

Therapeutic Area: Oncology

Job Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensure process validation activities are completed, while possessing strong communication skills and the ability to work collaboratively across various departments.

Primary Job Responsibilities:

  • Work with CMOs to support commercial manufacturing, technology transfer, and process validation activities for conjugation and drug product (DP) fill processes.
  • Collaborate with manufacturing and quality teams to provide technical support for process investigations and deviations, and compile and analyze process data to generate technical reports.
  • Lead technology transfer of multiple programs in late-stage development to the commercial phase, assist in scale-up activities, review process validation documentation, and contribute to regulatory filings.

Primary Jobs Requirements:

  • B.S. with 8+ years (M.S. 5+ years) in a pharmaceutical, biotechnology, or related industry, with direct hands-on experience in a manufacturing environment.
  • Understanding of conjugation and drug product (DP) fill manufacturing processes, experience with process validation, and a solid grasp of associated engineering principles.
  • Demonstrated ability to effectively communicate with CMOs, direct experience in authoring and reviewing CMC sections for regulatory filings, and a preference for candidates with experience in managing external manufacturing partners and working self-directed in a fast-paced environment.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

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