Apex Systems
Director Drug Product (Biologic)
Waltham, MA
Oct 17, 2024
Full-time
Full Job Description

Job#: 2049028

Job Description:

Director Drug Product (Biologic) 2049028
Location: Greater Boston, MA (Hybrid)
Job Overview: This Biologics focused CMC leader will oversee formulation development, drug product manufacturing processes, and coordinate tech transfers with CDMOs.
Primary Job Responsibilities:

  • Drive strategic and technical initiatives for drug product development including optimization and scale up

  • Manage CDMO activities to ensure drug product manufacturing processes are developed and maintained.

  • Design and execute Drug Product development studies (pre-formulation, formulation, and short-term stability)

  • Develop liquid and lyophilized formulations to support clinical stage biologic therapies

Primary Job Requirements:

  • Advanced degree in a scientific field preferred with over 7 years of biologic drug product development experience.

  • Expertise in developing lyophilized and liquid biologic formulations.

  • Strong exposure to managing CDMO’s and tech transfer related activities

  • Knowledgeable in ICH guidelines, GMPs, and regulatory standards with excellent teamwork and communication abilities.

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.

PDN-9d437f39-5e38-430a-aca0-d36c368a0c56
Job Information
Job Category:
Information Technology
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Director Drug Product (Biologic)
Apex Systems
Waltham, MA
Oct 17, 2024
Full-time
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