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Manufacturing Specialist - Tech Transfers

Company: Takeda Pharmaceutical
Location: Santa Monica
Posted on: September 24, 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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Manufacturing Specialist - Tech Transfers
Location: Thousand Oaks, CA

About the role:
Under direct supervision, the Manufacturing Specialist is responsible for the execution of all assigned processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Apply technical knowledge to perform complex trouble shooting tasks, participate in departmental projects and acts as delegate to the supervisor by conducting departmental activities in their absence. Additionally, this role will support the Manufacturing team through effective communication, guidance, and general oversight.

How you will contribute:

  • Ensuring successful implementation of New Product Introduction.
  • Contribute to complex, cross-functional, and high visibility sub-teams to advance Manufacturing goals.
  • Works with Quality to ensure that all quality and regulatory standards and requirements are implemented and maintained.
  • 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.
  • 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 (e.g., Master Batch Record, Bill of Material (BOM), and Recipe, Quality Risk Assessment, Hazard Analysis).
  • 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 and meets all targets for timely closure and CAPA completion.
  • Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input for analysis and driving process technology innovations.
  • Troubleshooting of equipment when failure occurs within the facility.
  • Offer advice to the management on technical advancements.
  • As applicable, serve as a representative on various global network teams or network-sponsored initiatives to advance the Final Drug Product operational practices and technologies.
  • Collaborate with Final Product Technologies, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the TT.
  • Develop and implement technologies that enhance our manufacturing operations. As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
  • Assist with preparation of regulatory submissions and inspections.
  • 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.
  • Must be able to work weekends and have flexibility to work extended shifts.
  • Ability to troubleshoot, demonstrate problem solving skills, and multitask while paying attention to timelines and priorities.
  • Thorough understanding of cGMP manufacturing, regulatory regulations, and requirements.
    What you bring to Takeda:
    • High school diploma or equivalent required. Bachelor of Science degree (engineering, biology, biochemistry, or related discipline) strongly preferred.
    • Minimum of 5 years' experience in pharmaceutical manufacturing, quality, and process development or 3 years relevant experience with Takeda.
      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 training and development opportunities
      • Tuition reimbursement
        Important Considerations
        At Takeda, our patients rely on us to deliver 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. In this role, you may:
        • The overall physical exertion of this position requires medium to heavy work.
        • May be required to gown frequently and balance when gowning into clean areas.
        • May require the use of special visual or auditory protective equipment.
        • May be required to work at heights above floor level.
        • May be required to walk or stand between 3-4 hours.
        • May be required to sit between 1-2 hours.
        • May be required to climb (use step stools and ladders) or kneel up to 1 hour.
        • Requires repetitive use of both right and left hands and arms up to 3-4 hours.
        • May require simple grasping & pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours.
        • May be required to work with biohazards such as: bloodborne pathogens, sewage or medical waste.
        • Will require entering a 2-8 degree Celsius & -60-degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg.
        • May require office work activities between 1-2 hours.
        • May work and have exposure to hot, cold, wet environment/conditions
        • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
        • May be required to work in confined areas; may be required to work around moving equipment and machinery.
        • Able to work in controlled or clean room environments requiring special gowning.
        • Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
        • May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling and on-site transporting of hazardous wastes.
        • Travel, as required, to other internal sites, vendors
        • Able to work 5 days a week/8 hours per day with flexibility for extended shifts.
        • May be required to work overtime, holidays, or be assigned to a different shift as needed.
        • May 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.
        • Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
        • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
          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 that will 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 deliver Better Health and a Brighter Future to people around the world.

          This posting excludes Colorado applicants.

          EEO Statement
          ..... click apply for full job details

Keywords: Takeda Pharmaceutical, Santa Monica , Manufacturing Specialist - Tech Transfers, Other , Santa Monica, California

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