Manager, Life Cycle Management

Posted 02 Sep 2020

Carlsbad, California - United States

Req Id 209708

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


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

 

RSRMS


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


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.

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