Supervisor, Technology Transfers

Company: Takeda Pharmaceutical
Location: Oxnard
Posted on: May 10, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:The Technology Transfer Supervisor requires cGMP manufacturing and cell culture processing expertise to manufacture product and collaborate for technical transfer to commercialize manufacturing. Additionally, you will manage Tech Transfer personnel with their training, development, performance, and other areas. You will report to the Head of Manufacturing Technology Transfers.How you will contribute:

• Primary contact for Operational Readiness process of new product introduction. Manage workflow and report out to project teams.
• Ensure successful implementation of New Product Introduction.
• Lead complex, cross-functional, and high visibility sub-teams to improve Manufacturing goals.
• Develop tech transfer staff regarding job knowledge, training, and practices. Mentor and career guidance of staff in cooperation with Director of Manufacturing.
• Lead staff to run Manufacturing operations.
• Timecard and vacation/sick time approval of tech transfer staff. Oversight and assignment of training roles in SABA.
• Work with Quality to ensure that all quality and regulatory requirements are implemented and maintained.
• Work with Business Excellence in identifying areas of potential efficiency during operations.
• Independently exercise good scientific and engineering principles in the performance of job responsibilities including collaborating on technical transfer to create a new commercial manufacturing process.
• Identify and lead process optimization programs and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
• Perform investigations including participation in yellow belt. Write and review technical SOPs, protocols, and (URS) user requirement specifications for processes and equipment as part of technical transfer.
• Follow and perform all tasks in SOPs and batch records for cGMP production.
• Aseptic cell processing, reagent preparation, cell counting, harvesting, aseptic filling, and packaging.
• 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.
• Work 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 create electronic batch records.
• Perform process mapping to develop a thoughtful 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.
• Manage inventories for consumables and raw materials, must be able to lift over 45lbs.What you bring to Takeda:
  • 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: Bachelor's degree in chemical or mechanical engineering and 1 or more years of pharmaceutical manufacturing, process development, quality experience, or bachelor's degree in a related discipline and a total of 10+ years pharmaceutical manufacturing experience.What Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • 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 and company match of charitable contributions
    • Family Planning Support
    • Professional development opportunities
    • Tuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to provide quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:
      • In general, it's a combination of sedentary work, going into the manufacturing area and supporting the daily activities.
      • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
      • Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
      • Work in a cold, hot, wet environment.
      • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
      • May work more than 8 hours a day and 40-hours per week.
      • May be available after hours or on call.
      • May work or be assigned to a different shift.
      • May work weekends and have flexibility to work extended shifts.
      • Holiday work required to support patient lots.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants.#GMSGQ#ZR1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA - CA - Thousand Oaks - Rancho ConejoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Oxnard , Supervisor, Technology Transfers, IT / Software / Systems , Oxnard, California