- 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.
- 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.
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Vertex Pharmaceuticals Boston, United StatesJob Description · Key Responsibilities: · - Represent the MSAT function in cross-functional teams as a materials science leader for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.- Support and champion continuous improvement and techn ...
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Apex Systems Waltham, United States FreelanceContractor, Process Engineer, Manufacturing Sciences (DS/DP) · Contractor, Process Engineer, Manufacturing Sciences (DS/DP · Location: · Waltham, MA (Hybrid) · Science: · Antibody Drug Conjugates · TherapeuticArea: · Oncology · Job Overview: · This role · will support comm ...
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TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Scientist or Process Engineer to join our Manufacturing Science team, ...
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Apex Systems Waltham, United States FreelanceJob#: · Job Description: · Contractor, Process Engineer, Manufacturing Sciences (DS/DP · Location: Waltham, MA (Hybrid) · Science: Antibody Drug Conjugates · Therapeutic Area: Oncology · Job Overview: This role will support commercial manufacturing, lead technology transfers, o ...
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Stratacuity Waltham, United States FreelanceLocation: 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 st ...
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Stratacuity Waltham, United States FreelanceLocation: · 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 poss ...
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Stratacuity Waltham, United States FreelanceLocation: 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 stron ...
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TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Scientist or Process Engineer to join ...
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Apex Systems Watertown, United States FreelanceContractor, Process Engineer, Manufacturing Sciences (DS/DP Location: Waltham, MA (Hybrid) Science: Antibody Drug Conjugates TherapeuticArea: Oncology Job Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensure process valida ...
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Apex Systems Watertown, United States FreelanceContractor, Process Engineer, Manufacturing Sciences (DS/DP · Location: Waltham, MA (Hybrid) · Science: Antibody Drug Conjugates · TherapeuticArea: Oncology · Job Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensur ...
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Stratacuity Watertown, United States FreelanceLocation: Waltham, MA (Hybrid) · Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. · Science: Antibody Drug Conjugates · Therapeutic Area: Oncology · Job Overview: This role will ...
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Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · As part of the MSAT team, the Senior Manager of Drug Product Manufacturing Science and Technology, will manage tech transfer and process validation at contract drug product manufacturing sites. The Senior Manager of Drug Produc ...
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Sarepta Therapeutics Burlington, United StatesWith the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. T ...
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Sarepta Therapeutics Burlington, United StatesWith the exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for Principal Engineer/Senior Manager to support Sarepta's diverse gene therapy portfolio and to deliver new treatments for patients. T ...
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Director, Manufacturing Sciences and Technology
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Moderna, Inc. Norwood, United States Full timeThe Role: · This position is part of Modernas Manufacturing Sciences and Technology (MST) team responsible for ensuring robust production of Drug Substance (DS) using our mRNA manufacturing platform at our Norwood site. The Director/Senior Director will have full responsibility f ...
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Lab Technician
1 week ago
Actalent Waltham, United States Full timeDescription: · Responsibilities: · • Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities. · • Practices safe work habits and adhere to TScan's safety procedures and guidelines. · • Follows verbal and written procedures in operating produ ...
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Lab Technician
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Actalent Waltham, United States Full timePlease See Below for a Great Opportunity to get your foot in the door with one of the top Scientific organizations in the Portsmouth, NH areaThis Opportunity allows for a lot of growth and ability to work with Scientific Manufacturing and Laboratory techniques · MUST HAVE CELL TH ...
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Lab Technician
1 week ago
Actalent Waltham, United States Full timeDescription: · Responsibilities: · • Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities. · • Practices safe work habits and adhere to safety procedures and guidelines. · • Follows verbal and written procedures in operating production eq ...
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Lab Technician
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Actalent Waltham, United States Full timeCome work for a leading clinical biopharmaceutical company in the Greater Boston area · If interested and qualified please apply and reach out directly to Stephanie Lipari at slipari@ · Description: · Responsibilities: · • Effectively demonstrates understanding of GMPs and how ...
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Biomanufacturing Associate Iii
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Contractor, Process Engineer, Manufacturing Sciences - Waltham, United States - Stratacuity: Proven Scientific Placement
Description
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:
Primary Jobs Requirements:
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 PLACEMENTTM
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
