- 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.
-
The Steely Group Waltham, United StatesOur client is looking for an outstanding candidate for a critical position to lead their Manufacturing Science and Technology (MSAT) Organization in support of their growing client portfolio for genomic medicines. This role is responsible for leading and growing a team responsibl ...
-
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, supp ...
-
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 ...
-
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 ...
-
Director, Manufacturing Science
1 day ago
Lantheus Medical Imaging North Billerica, United StatesJob Description · Job Description · Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient ca ...
-
Director, Manufacturing Science
6 days ago
Lantheus Medical Imaging Inc North Billerica, United StatesJob Description · Job DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care wi ...
-
Director, Manufacturing Science
5 days ago
Lantheus North Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.La ...
-
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 ...
-
Moderna Norwood, United StatesDirector, Manufacturing Sciences and Technology page is loaded · Director, Manufacturing Sciences and Technology · Apply · locations · Norwood, Massachusetts · Drug Manufacturing · time type · Full time · posted on · Posted Yesterday · job requisition id · R15485 · Th ...
-
Moderna Norwood, United StatesThe Role: · This position is part of Moderna's 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 responsibili ...
-
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 ...
-
Manufacturing Science and Technology Associate
4 weeks ago
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 ...
-
Lantheus North Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.La ...
-
Lantheus Medical Imaging Inc North Billerica, United StatesJob Description · Job DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care wi ...
-
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 ...
-
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 ...
-
Moderna, Inc. Norwood, United States Full timeThe Role: · The Sr. Manager, MS&T, will be part of Modernas Manufacturing Science and Technology team responsible for process implementation, technical support, and person-in-plant coverage to ensure robust production of our DNA plasmid, chemistry, and small-scale drug substance ...
-
Consulting Engineer
1 week ago
Project Farma (PF) Waltham, United StatesThis role can involve up to 100% Travel · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science i ...
-
Manager Chemical Development
2 weeks ago
1925 GlaxoSmithKline LLC Waltham, United States Full timeThe Manager for Chemical Development (Engineering) will be responsible for the external development, scale-up, technology transfer and management of robust, cost effective, and safe processes for the manufacture of small molecule and antibody-drug conjugates (ADCs) drug substan ...
-
Supplier Quality Engineer
2 weeks ago
Boston Dynamics Waltham, United StatesAs a Supplier Quality Engineer at Boston Dynamics, you will manage our component supply base to ensure that our suppliers are delivering high-quality products to our assembly operations for both our Spot and Stretch robots. Every day, you will collaborate with our Manufacturing t ...
Contractor, Process Engineer, Manufacturing Sciences - Waltham, United States - Apex Systems
Description
Job#: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, 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:
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
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.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex 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 our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
&v=024){kind=logo}
