Contractor, Process Engineer, Manufacturing Sciences (DS/DP) 2029852
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 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™
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 [email protected] or 844-463-6178.

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.