Manager, Cell Banking jobs in United States
cer-icon
Apply on Employer Site
company-logo

Johnson & Johnson Innovative Medicine · 7 hours ago

Manager, Cell Banking

Johnson & Johnson is a leader in healthcare innovation, committed to developing the medicines of tomorrow. The Manager of Cell Banking will oversee support functions for the Cell & Gene Therapy group, managing investigations, testing strategies, and batch release activities for biopharmaceutical and cell therapy products.

Pharmaceuticals

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

Qualification

Cell cultureGMP environmentBatch release activitiesCryopreservationBiologics shippingData reportingForecastingBudgetingAnalytical ReasoningBiochemistryTechnical CredibilityLeadershipTeam Management

Required

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
Experience working in a GMP environment is required
Experience managing people required
Experience maintaining writing records of work in form of (electronic) notebooks, procedural documents, protocols and technical reports is required
Strong verbal and written communication abilities required
Experience in maintaining team-based Collaborations is required
Focus on achievement and delivery of results with high sense of urgency

Preferred

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 managing facility construction projects and equipment validation is preferred
Experience with forecasting and budgeting
Accurate Data reporting and ability to present findings to management
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
Occasional weekend work may be required and willingness to travel up to 10%

Company

Johnson & Johnson Innovative Medicine

twittertwitter
company-logo
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.