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Associate Director, CMC Technical Operations (Biologics) 1254166 Job Scope & Purpose: Our client focused in treating patients with rare genetic disorders is looking for a CMC technical operations leader with a strong background in biologics technical operations and manufacturing. This person will partner closely with external manufacturing partners for tech transfer, process development and manufacturing efforts. Primary Job Responsibilities:
- Lead cell line development including upstream and downstream process optimization, characterization, validation, PPQs for late-stage manufacturing
- Manage necessary audits and serve as person in plant for GMP manufacturing across sites
- Manage all forms of late-stage formulation and analytical development, CQA establishment, qualification, validation, stability protocols, reference standard characterization, and GMP Drug substance release
- Collaborate with internal stakeholders to select reliable and experienced GMP CDMO manufacturing partners in support of CMC technical operations
- Ensure internal and external compliance with quality and regulatory in support of manufacturing campaigns
- Author sections of the CMC modules in support of IND and BLA submissions
Primary Job Requirements: - Advanced Scientific education ideally with extensive experience in cell line and process development, optimization, bio-manufacturing to support both early and late-stage clinical development.
- Strong background in upstream and downstream process development including characterization and validation studies for biologics.
- Experienced with successful IND and BLA submissions for biologics
- Strong problem-solving and troubleshooting skills
- Ability to travel domestic and international (on a limited basis)
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. Code:TechOps, HybridEEO EmployerApex 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 . Vacancy expired!
