Associate Director/Director, CMC Project Management
Director CMC Project Management 1329605
Location: Greater Boston Area (Hybrid)
Science/ Focus: Gene Therapy
Job Overview: Manage multiple ongoing CMC (DS, DP, Supply) projects to ensure they achieve operational success in terms of meeting timelines, regulatory objectives, key milestones.
Responsibilities:
- Create CMC project plans including resource needs both internal and external to achieve program and corporate objectives
- Manage meetings and team coordination by creating meeting agendas, action plans, and providing thorough follow-up
- Help maintain financial responsibility for CMC programs, ensuring budgets are in place, adhered to, and change controls followed
- Deliver project status updates to essential project participants and stakeholders including dashboards and reports
Requirements:
- 6+ years of experience in CMC Project Management in Pharmaceutical/ biotech
- Relevant life science background and experience working with external manufacturing/ CDMOs
- Previous experience with quality standards for batch release
- Experienced with typical PM tools including Microsoft Project, Smartsheet
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
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 employeeservices@apexsystems.com or 844-463-6178.