Manager, Cell Banking

Location: Malvern

This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn

more at
Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub     Function:
Biotherapeutics R&D

Job Category:
People Leader

All Job Posting Locations:
Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
We are searching for the best talent for the best  Manager, Cell Banking,  to be in Malvern, PA.

Purpose:

The Manager of Cell Banking will lead support functions for the Cell & Gene Therapy group in Malvern, PA. The candidate's primary responsibilities will include managing and leading investigations, testing strategies, batch release and shipping activities for J&J biopharmaceutical and cell therapy products. The candidate will also lead innovation initiatives within the Cell Banking group. The candidate will coordinate timelines with the project teams and external testing laboratories.

The candidate may also manage direct reports. Responsibilities also include authoring technical documents, regulatory filings, supporting quality events and change controls, and contributing to technology transfer to collaboration partners. The candidate is expected to work in a team environment as well as contributing individually to meet project timeline and objectives.

Key Responsibilities:

• Supports Cell banking for all cell bank support functions processes for the Cell & Gene Therapy Cell banking organization.

• Manage testing and release of Master, Working, development, and analytical cell Banks and ensures the timely supply to customers.

• Work in a team environment as well as contributing individually to meet project timeline and objectives

Role Responsibilities:

• Author, review and approve technical documents, regulatory filings, supporting quality events, SOPs, batch records and change controls.

• Contribute to technology transfer to collaboration partners.

• Provide technical reviews of cell bank characterization test reports, resolve issues with external testing laboratories.

• Drive investigations when required.

• Manage direct reports.

• Execute change controls, new technology and raw material evaluations and support investigations.

• Lead facility improvement projects when required.

• Coordinate timelines with the project teams and external testing laboratories.

• Executes all activities per established procedures and protocols.

• Collaborate cross-functionally to represent Cell Banking department.

• Successfully completes regulatory and job training requirements;
Makes a positive contribution to the organization, seeks opportunities for improvement.

• Support to regulatory inspections through directly interfacing with auditors or providing support in the back room

• Forecast spend and budgeting for base business and project work

Qualifications:

• PhD in Chemical Engineering or Biological Sciences or Biochemistry with at least 3 years of relevant post-doctoral experience OR BS or MS in Chemical Engineering or Biological Sciences or Biochemistry and with at least 6-8 years of experience.

• Knowledge and hands-on experience in cell culture, cryopreservation and cell bank testing is preferred.

• Experience with batch release…