Associate Director, CMC Biologics Drug Product

  • Boston, MA
  • Posted 50 days ago | Updated 10 hours ago

Overview

On Site
Full Time

Skills

Life sciences
Chemical engineering
Strategy development
Product development
Process engineering
Quality control
Project management
Problem solving
IT service management
CMC
Mergers and acquisitions
Science
Leadership
Collaboration
Management
Analytical skill
Proposal writing
Negotiations
Facilitation
Pharmaceutics
Biotechnology
GMP
Manufacturing
Network
Law
Oracle Application Express
SAP BASIS
Innovation
Training
Recruiting

Job Details

Job#: 2026530

Job Description:

Associate Director, CMC Biologics Drug Product 2026530
Location: Newton, MA (Onsite)
Science: Monoclonal antibody therapeutics
Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners to oversee and plan CMC development, supporting company growth towards clinical studies and commercial launch.
Primary Job Responsibilities:
  • Develop and evaluate antibody-based product formulations, drug products, and analytical characterization studies in the laboratory.
  • Collaborate with the Discovery group to identify best molecule candidates and support CMC progression from proposal to completion.
  • Coordinate and support outsourced CMC development activities, ensuring projects are completed effectively and efficiently.
  • Serve as a liaison between internal and external partners, negotiating agreements and facilitating approvals for proposals, work orders, and changes.
Primary Job Requirements:
  • Bachelor, Master, or PhD degree in Life Sciences, Pharmaceutical Sciences, Bioprocess, or Chemical Engineering, or a related field.
  • Minimum of 9 years of experience in the biotechnology industry, with extensive knowledge in bioprocess, formulation, and/or analytical strategy development, exposure to GMP manufacturing of biologics, and experience with global contract manufacturing networks and 3rd party relationships for process and product development.
  • Strong understanding of biopharmaceutical process development, including biologics (mAB) Drug Substance and Drug Product process development, as well as analytical development and quality control.
  • Proven track record in project management, problem-solving, and interpersonal skills, with the ability to work cross-functionally across technical, business, and operational areas.

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.

About Apex Systems