CMC Lead
Location: Greater San Francisco, CA
Contact: info@bandishgroup.com
THE ROLE:
CMC Lead | Clinical Stage Biotechnology Company
DESCRIPTION:
We seek to identify a CMC Lead for our clinical-stage biotechnology company client located in the San Francisco area.
In this role, one will support US regulatory activities related to our client’s cellular therapy programs, including leading the CMC product strategy for an innovative CAR T pipeline. We are looking for a candidate who is experienced in cell therapy drug development in a biotechnology setting.
This is a critical position that will play a key role in establishing and maintaining effective relationships with health authorities and cross-functional partners. Reporting to the Head of Clinical Development, this individual will be responsible for assuring the CMC product/regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality.
HIGHLIGHTS OF RESPONSIBILITIES:
Direct GMP-compliant manufacturing operations, including technology transfer, process development and optimization, and GMP manufacturing.
Ensure the development and optimization of robust and scalable CAR T manufacturing processes, focusing on yield, purity, and product consistency.
Ensure compliance with relevant regulatory guidelines, including FDA and other global health authorities.
Collaborate with cross-functional teams and ensure integration of CMC activities with overall company objectives.
Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs).
Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for CMC related issues and for inspections.
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
Manage contract staff and vendors as needed to support regulatory activities.
Drive Process Development group goals and assist in managing project plans, timelines, and budgets.
Establish the strategy and infrastructure for developing novel production processes for candidate engineered T cell therapeutics, ultimately leading to GMP-compliant manufacturing processes for early and late phase clinical trials.
Assist in managing the translation of Research & Development programs to GMP manufacturing.
DESIRED SKILLS AND QUALIFICATIONS:
10+ years of drug development experience, with a recent focus on CAR T cell therapy.
Advanced scientific degree preferred in the sciences, or health related field or equivalent experience.
Demonstrated CAR T process development and technology transfer experience leading to regulatory filings and late-stage clinical supply.
In-depth knowledge of GMP regulations and industry best practices for CAR T manufacturing.
CMC regulatory experience in the pharmaceutical/biotech industry.
Established working knowledge of regulatory guidelines and regulations including Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines (e.g., ICH, FDA and EMA guideline).
Experience with Orphan Drug Designation, BTD, RMAT, direct interactions supporting health authority GMP inspections is preferred.
Experience in tech transfer and process characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment.
Prior supervisory experience preferred.
Ability to work in a fast-paced, start-up environment.
Ability to translate vision into actionable plans and drive results.
Skilled at engaging team members across multifunctional areas while prioritizing multiple projects and meeting deadlines.
CONTACT:
For additional information about this role, contact a member of our team at 267-483-5233 or info@bandishgroup.com.
The Bandish Group, LLC
Life Sciences Executive Search
Greater Philadelphia Region
www.bandishgroup.com