Associate Director\/Director CMC Project Management

Director CMC Project Management

Job Scope & Purpose:

Our well-funded client is looking for a motivated, dynamic and collaborative Director level CMC Project Manager to join a growing established team focused on translating innovative science into medical breakthroughs for patients. The CMC Project Manager will oversee CDMO activities for partnered CMC projects involving cell therapy product candidates and required starting materials (viral vector, feeders) for all phases of clinical development and beyond.

The CMC Project Manager will also work closely with leadership to shape manufacturing and supply strategy and drive operational execution of strategic projects; and with functional leaders to establish a project management practice for internal CMC projects including the preparation and maintenance of project plans and budgets. The ideal candidate will bring a passion for project management and collaboration in a fast-paced biotech environment.

Primary Job Responsibilities:

• Lead CMC project management within Technical Development and Manufacturing; this will begin as an individual contributor role working with matrixed project teams. With portfolio expansion and progression of our pipeline, there will be future potential to expand the team.
• Drive flawless execution of CMC partnerships in support of strategy. Serve as primary technical point-of-contact, managing communications and responsible for managing meetings, setting agendas, recording minutes in collaboration with counterpart at partner
• Coordinate completion of agreements, SOWs, invoice payments and manage the overall relationship with the CDMOs
• Work with Head of Technical Development and Manufacturing and team members to develop and maintain an integrated project plan for CMC activities with timelines, and risks. Interface and coordinate with program management / program strategy team as needed
• Develop a framework for internal CMC operations to assess progress against goals and report metrics to drive resource allocation, workforce planning and investment decisions
• Support long-term planning and strategy development and facilitate decision making related to investments in technology, manufacturing cost analysis, and facility / capacity planning.
• Proactively monitor all CMC deliverables and activities at partner to effectively identify, manage, mitigate, and communicate risks

Primary Job Requirements:

• PhD or advanced scientific/ engineering education preferred but would also consider a highly accomplished BS
• 10+ years CMC experience in biopharma with at least 3 years' experience as a project manager leading functional or cross-functional teams within a CMC or manufacturing function
• Strong knowledge and understanding of the CMC development for biologics including regulatory requirements
• Exceptional project management skills and the ability to build productive partnerships, and communicate, collaborate, and influence effectively throughout all levels of the Company and external partners
• Prior experience in development of gene therapy and/or cell therapy product for immuno-oncology or other applications would be ideal but is not required.
• Desire and ability to work in an entrepreneurial, collaborative environment, and manage multiple responsibilities in parallel with minimal direction
• Proficiency with MS Excel, PowerPoint, and MS Project

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 or . - provided by Dice