Scientist I, Tech Transfer

Posté 29 nov. 2022

Carlsbad, California - United States

Demander un identifiant 258681

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 


 

We are offering a $7,500 sign-on bonus for those that qualify!

 

Your Role:

The Scientist I will support our Viral Vector Manufacturing facility in Carlsbad, CA. It’s a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a Scientist I, Tech Transfer who will be responsible for supporting process transfer from Development to cGMP Manufacturing as a member of the Tech Transfer team within Technical Operations. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work cross-functionally with the Manufacturing, Process Development, and Project Management teams to ensure successful and timely process transfer and scale-up for critical client-facing projects.

  • Generate documentation (item specifications, batch records, SOPs, bills of material, production summaries, etc.) based on inputs from the development team and requirements/constraints provided by the Manufacturing, Quality, and Operations teams
  • Support the execution of engineering/pilot runs for viral production and purification processes and train manufacturing staff independently on transferred processes as needed
  • Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose solutions
  • Source materials internally/externally for the completion of full-scale pilot runs and define final material and labor requirements for Manufacturing
  • May lead projects in transferring processes from development to manufacturing by collaborating cross-functionally with both internal and external stakeholders and participating in project readiness reviews
  • Provide additional support and cross-train as business needs arise

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science field
  • 7+ years of experience in process development, engineering, and/or manufacturing experience
  • 2+ experience with cGMP manufacturing and Quality Systems within a regulated environment

 

OR

  • Master’s Degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science field
  • 5+ years of experience in process development, engineering, and/or manufacturing experience
  • 2+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment

 

OR

  • Ph.D. in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science field
  • 6+ months of experience in process development, engineering, and/or manufacturing experience
  • 2+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment

 

Preferred Qualifications:

  • CMO experience
  • Familiarity with cGMP document control systems and general procedures
  • Technical expertise in technology transfer and broad knowledge of principles, practices, and procedures in field of specialization
  • Experience in evaluating new techniques and procedures for systems, products, or technologies with limited/minimal oversight
  • Critical thinking skills that translate into improved outcomes/outputs, and ability to effectively solve and de-risk technical problems and form solutions/plans to mitigate issues
  • Ability to exercise independent judgment in fast-paced, high-pressure environment with strict deadlines and multiple projects
  • Excellent attention to detail, with superior documentation and organization skills
  • Excellent computer, verbal, and written communication skills, including strong technical writing ability and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience

 

Pay Range for this Position- $49,500 - $148,900

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.  Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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