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Manager, Life Cycle Management

Your Role:

The Carlsbad Gene Therapy Viral Vector Manufacturing site produces drug substance and drug products for gene therapy and oncology applications. We are seeking a Manager who will be responsible for building and directing a Life Cycle Management team to implement changes to bioprocesses in cGMP production. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work with internal and external stakeholders to manage complex timelines, meet customer expectations, and develop a best-in-class organization. This role is responsible for developing a comprehensive Life Cycle Management program and strategy that meets current compliance requirements. This includes but is not limited to updating Batch Records, Item Specifications, and SOPs, preparing reports, streamlining processes, interacting with clients, training manufacturing operators on new processes, and supporting the execution of upstream and downstream unit operations under cGMP.

 

  • Help define and lead the overall product life cycle management strategy to enable continuous improvement of existing manufacturing processes
  • Work cross-functionally with the manufacturing, process development, and quality teams as well as external clients to facilitate changes to existing processes in manufacturing that are robust, repeatable, and cGMP compliant
  • Collaborate cross-functionally on various projects, including executing process risk assessments, developing and driving continuous improvements, and other operational activities that increase safety, reduce operational costs, and improve manufacturing processes
  • Coordinate change management to update manufacturing documentation, including batch records, item specifications, forms, SOPs, and bill of materials for existing clients/processes
  • Identify and help qualify secondary vendors for raw materials and conduct impact assessments for supplier change notifications
  • Provide process oversight and upstream and downstream technical support/ troubleshooting for Engineering and cGMP runs incorporating process changes
  • Provide technical support during client and regulatory agencies site audits as needed
  • Proactively identify process gaps, perform root cause analysis, and propose solutions
  • Communicate effectively with Technical Operations Leadership team, internal and external network partners and the Product Teams
  • Support and implement best-in-class systems and processes/procedures that comply with increasing regulatory standards

 

Who You Are:

 Basic Qualifications:

  • Master’s in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field
  • 8+ years of pharmaceutical process development, engineering and/or manufacturing experience
  • 2+ years of leadership/supervisory experience; employee coaching and development, determining responsibilities, and evaluating and measuring performance
  • 2+ years of cGMP manufacturing and Quality Systems within a regulated environment

 

Preferred Qualifications:

  • PhD in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field
  • Experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems
  • Innovative problem-solving and integrated view of business/scientific issues
  • Ability to work independently as part of a team and manage multiple projects simultaneously
  • Strategic planning/design, tracking, time and priorities management skills
  • Detail oriented and organized
  • Excellent computer, verbal, and written communication skills
Job Requisition ID:  209708
Location:  Carlsbad
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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