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Drug Substance Supervisor

応募後で応募 求人ID R0065290 掲載日 05/10/2022 Location:Thousand Oaks, California

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Job Description

Job Title: Drug Substance Supervisor

Location: Thousand Oaks, CA

About the role:

The Drug Substance (DS) Supervisor oversees manufacturing operations while maintaining compliance with environmental, health and safety (EHS) guidelines, current good manufacturing practices (CGMPs) and any other regulation that could apply. Additionally, you will manage DS personnel with their training, development, performance, and other areas. You will report to the Drug Substance Manager.

How you will contribute:

  • Oversee on the floor operations of your designated responsibilities including oversight of daily production and scheduling.
  • Build a team, provide training and ongoing coaching, discipline, and recognition of staff, including annual performance reviews
  • Lead technical reviews, investigation, and process improvement projects.
  • Contribute to integration and validation of new equipment and process.
  • You will resolve technical, material, and CGMP issues.
  • Review, and manage documentation for batch and system records for production.
  • You will communicate with other departments and external vendors to help resolve issues related to equipment, process, and compliance.
  • Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, help train and auditing.
  • Owner for implementation of new equipment, system and procedures.
  • You will participate in all audits as SME for department.
  • Knowledge of Cell Culture, Purification, and Buffer/Media manufacturing operations.
  • You will have general knowledge of Utility Systems and its impact to manufacturing departments.
  • Knowledge of manufacturing equipment operation, including set up and changeover, and commissioning, validation, and troubleshooting.
  • You will have basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
  • May have more specific skills in areas depending on need/ opportunity: Aseptic technique, column packing, inoculum operations, chromatography operations.
  • You will have knowledge of clean room management.
  • You will prepare and write technical reports
  • Proficient in PowerPoint, Word, and Excel (can maintain complex spreadsheets).
  • You will adapt in a constantly evolving environment.
  • You will operate with flexibility and a learning mindset to improve.

What you bring to Takeda:

  • Bachelor's Degree preferred (scientific or engineering discipline) plus 3 or more years of manufacturing experience, or AA Degree with 5+ years of manufacturing experience, or HS Diploma with 7+ years of manufacturing experience.
  • 2 or more years of leadership 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 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. 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 hot, cold, wet environment.
  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
  • Will work 4 days a week, 10 hours a day.
  • Requires weekend and holiday work
  • May be required to more than a 40-hour work week.
  • May be available after hours And on call.
  • May work or be assigned to a different shift.

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.

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EEO Statement

Takeda 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.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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