6 days old

Tech Transfer Manufacturing Supervisor

Baxalta U.S., Inc.
Thousand Oaks, CA 91362
  • Job Code
    R0039235

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Tech Transfer Manufacturing Supervisor in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

In this role you will be empowered to perform cGMP manufacturing and cell culture management with processing expertise to manufacture product and collaborate for technical transfer to commercialize manufacturing.

Essential Duties and Responsibilities

  • Primary contact for Operational Readiness workstream of new product introduction. Management of workflow and report out to project teams.
  • Ensuring successful implementation of New Product Introduction.
  • Lead complex, cross-functional, and high visibility sub-teams to advance Manufacturing goals.
  • Timecard and vacation/sick time review and approval of tech transfer staff as needed. Oversight and assignment of training roles in SABA.
  • Development of tech transfer staff with regard to job knowledge, training and practices. Mentoring and career guidance of staff in cooperation with Director of Manufacturing.
  • Works with Quality to ensure that all quality and regulatory standards and requirements are implemented and maintained.
  • Works with Business Excellence in identifying areas of potential efficiency during operations.
  • Independently exercises good scientific and engineering judgement in the performance of job duties including collaborating on technical transfer to create a new commercial manufacturing process.
  • Identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Leading and training staff to run Manufacturing operations.
  • Performance of investigations including participation in yellow belt problem solving.
  • Must be able to follow and perform all tasks in SOPs and batch records for cGMP production; weekend and holiday shift work required to support patient lots as needed.
  • Aseptic cell processing, reagent preparation, cell counting, harvesting, aseptic filling, and packaging.
  • Write and review technical SOPs, protocols, and (URS) user requirement specifications for processes and equipment as part of technical transfer.
  • Write and update manufacturing batch records.
  • Perform equipment installation and operational qualifications for cGMP cell processing.
  • Support tech transfer to commissioning, validation to commercializing of manufacturing.
  • Works with the process control engineering Intelligence team to ensure plant level MES data can be consumed.
  • Engagement of MBR Design, MES Infrastructure, and Shop Floor Integrator to coordinate technical aspects of MES such as interfaces and MES enhancements
  • Collaborate with MES programmers to generate electronic batch records.
  • Perform process mapping to develop a thorough understanding of operating and performance parameters.
  • Ensure product, sample, and data integrity
  • Investigate quality deviations and write-up investigations
  • Aid in materials management and establishment of new inventories/logistics for process raw materials in JDE.

Qualifications

  • Ability to troubleshoot, demonstrate problem solving skills, and multitask while paying attention to timelines and priorities
  • Fluency with cGMP manufacturing, regulatory regulations and requirements
  • Highly motivated, proactive and enthusiastic team player with demonstrated history of flexibility
  • Ability to work effectively, collaborate cross-functionally, and utilize resources efficiently
  • Excellent organizational, interpersonal, verbal and written communication skills

Education and/or experience

  • Education: Bachelor of Science degree in chemical or mechanical engineering, or Bachelor of Science in biology, biochemistry or related discipline and 10+ years of pharmaceutical manufacturing experience
  • Experience: Bachelors degree in chemical or mechanical engineering and 1-3+ years of pharmaceutical manufacturing, process development, quality experience, or Bachelors degree in a related discipline and a total of 10+ years pharmaceutical manufacturing experience.
  • Must be able to work weekends and have flexibility to work extended shifts

Physical Demand

  • Manage inventories for consumables and raw materials, must be able to lift over 45lbs

Working Environment

  • Clean room environments, machine shop floor, light industrial

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

This posting excludes CO applicants.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-09 Expires: 2021-07-08
Sponsored by:
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Sponsored by:
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Tech Transfer Manufacturing Supervisor

Baxalta U.S., Inc.
Thousand Oaks, CA 91362

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