Director/ Sr. Director of CMC 1224279

Company: Stratacuity: Proven Scientific Placement
Location: Cambridge
Posted on: May 11, 2022

Job Description:

Job Scope & Purpose:

Our client is a leader in the gene therapy space with strong funding and a bright future of transforming medicine for patients in a broad range of therapeutic areas. This CMC leader will be the point person for driving strategic decisions, prioritization and timely execution of CMC activities for clinical stage programs across Technical Operations, Manufacturing, Supply Chain, Process Development, Analytical Development, along with Quality and Regulatory. This demonstrated leader will work collaboratively with internal partners in a rapidly growing company against tight and changing deadlines to define and implement the vision to assure robust supply of cell therapy products. The ideal candidate will be strategic, highly knowledgeable in cell and gene therapy, have a solid technical operation and program management background, and understand the challenges and impact of managing an organization that can handle multi-products in development, from early-stage through late stage development and into GMP manufacturing.
Primary Job Requirements:
PhD or MS degree in Life Sciences background with a focus in immunology, cell biology, biochemical engineering
8-10 years industry experience working in cross-functional leadership roles, with demonstrated strength in process and analytical development, cGMP manufacturing, and technical operations, ideally through the lens cell or gene therapy
Understanding of biologic clinical and regulatory development pathways, including key milestones such as opening INDs, PPQ, late stage development and inspection readiness
Demonstrated ability to lead through influence, driving decisions through matrix teams and solidifying endorsement with senior management
Demonstrated experience in management of external partners
Strong leadership and an innate ability to collaborate and build relationships
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.

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