Associate Director, Upstream Process Development

Associate Director, Upstream Process Development

01 Jul 2024
Indiana, Indianapolis, 46201 Indianapolis USA

Associate Director, Upstream Process Development

Vacancy expired!

Rapidly growing CDMO seeks an experienced Upstream PD Associate Director with experience with bioreactors and scale up from 5L to 200L

This Jobot Job is hosted by: Hunter Prater
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A bit about us:

Our client is a rapidly growing CDMO dedicated to the development and production of novel gene therapy products

Why join us?

Rapidly growing startup culture
Ability to "make it your own"
3 weeks vacation in addition to 1 week paid sick leave
Relocation assistance available
Annual Bonus structure

Job Details

Our client is actively seeking an Upstream Process Development (USP) Associate Director to join a Lentiviral vector manufacturing CDMO.This individual will provide excellent scientific, technical and leadership expertise to upstream process development activities. This individual will display strong technical knowledge and scientific understanding of mammalian cell culture and use of bioreactors for process development at both small and large scales. The person in this scientific role is expected to work collaboratively with the team to establish and implement best laboratory practices and lead the execution of complex experiments.

ESSENTIAL JOB FUNCTIONS
  • Manage the USP team, including hiring, training, career and goal development and assessment
  • Perform process development with manufacturing scalability as outcome for both adherent and suspension cell cultures for viral vector or mammalian protein production
  • Evaluate transferred upstream process for feasibility and scalability
  • Scale-up and scale-out of cell culture processes using adherent and suspension platforms
  • Conduct seed train expansion, bioreactor inoculation, media preparation, transient transfections, cell culture harvest and cell culture clarification
  • Make determinations about suitable cell growth, viability and media use for viral vector productions
  • Conduct media screening and development and fed-batch operation for bioreactor cultures
  • Work with cell cultures from shake flask stage through 200L operations utilizing transient and stably transfected cells
  • Collaborate with analytical and downstream functional areas to determine appropriate process for better viral titer/protein production
  • Communicate with clients and internal quality and regulatory groups to transfer processes
  • Communicate with internal teams for internal technology transfer process
  • Maintain high quality deliverables and open communication, creating a collaborative working environment
  • Schedule, train and mentor junior laboratory staff and assist with their technical development
  • Serve as a subject matter expert in one or more selected areas of cell culture development
  • Lead projects to develop and implement industry leading cell culture production technologies and platforms
  • Review technical documents for accuracy, thoroughness and regulatory compliance
  • Participate in proposals to improve upstream process development approaches
  • Provide monthly reports to department head
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the USP functional area

KNOWLEDGE, SKILLS AND EXPERIENCE
  • B.S. in Cell biology, Biotechnology, Biology or similar discipline + 10 years of industry experience

o A minimum of 5 years of experience with a M.S. or 3 years of experience with a PhD
  • Prior knowledge or experience with adherent and suspension cell culture, bioreactor systems for mammalian protein production, and media development/screening
  • Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

PREFERRED QUALIFICATIONS
  • Cell line development experience
  • 3+ years of cGMP experience


Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

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Job Details

  • ID
    JC43742423
  • State
  • City
  • Job type
    Permanent
  • Salary
    Based on Experience
  • Hiring Company
    Jobot
  • Date
    2022-06-30
  • Deadline
    2022-08-29
  • Category

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