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
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