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 MedTech, 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 https://www.jnj.com
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 https://www.jnj.com/innovative-medicine
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 activities preferred
Experience with shipping biologics (domestic and internationally) preferred
Experience working in a GMP environment is required.
Experience managing people required
Experience managing facility construction projects and equipment validation is preferred.
Experience maintaining writing records of work in form of (electronic) notebooks, procedural documents, protocols and technical reports is required.
Accurate Data reporting and ability to present findings to management.
Strong verbal and written communication abilities required.
Highly organized and capable of managing/pursuing multiple projects independently.
Ensures project results, findings and data is communicated to management in a clear and timely fashion.
Experience in maintaining team-based Collaborations is required.
Experience with forecasting and budgeting
Focus on achievement and delivery of results with high sense of urgency
Occasional weekend work may be required and willingness to travel up to 10%
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Quality Assurance (QA), Scientific Research, Team Management, Technical Credibility
