Drug Product Supervisor応募後で応募 求人ID R0067364 掲載日 05/13/2022 Location:Thousand Oaks, California
Job Title: Drug Product Supervisor
Location: Thousand Oaks, CA
About the role:
The Drug Product Supervisor implements and oversees the Formulation/Filling manufacturing areas to ensure goals and project deadlines are met while maintaining compliance with current good manufacturing practices (CGMPs), environmental health and safety (EHS) guidelines and any other regulations. You will report to the Head of Drug Product.
How you will contribute:
- Provide leadership and oversight of approximately 5-8 direct reports on grave shift.
- Build a team, provide training and ongoing coaching, discipline, and recognition of staff, including annual performance reviews.
- Manage the daily production, scheduling, staffing, material management, compliance, training, and auditing activities.
- Guide operational excellence through the AGILE (Business Excellence) operating system (AOS) with a focus on meeting the Master Production Schedule and Lead Time for all products.
- Manage Tier I AOS board.
- Manage on the floor 50% of the time.
- Become qualified to implement different operations
- Develop performance of direct reports.
- Support and ensure the execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Lead technical reviews, investigation, and process improvement projects.
- Contribute to integration and validation of new equipment and process.
- Resolve technical, material, and cGMP issues.
- Review, and manage documentation for batch and system records for production.
- Communicate with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.
- Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, help train and auditing.
- Participate in audits as SME for department.
- You will operate with agility and a learning mindset to improve.
- Knowledge of Formulation, Filling and Capping manufacturing operations, including lean manufacturing.
- Knowledge of Utility Systems and how they affect the Manufacturing Departments.
- Understand the flow and design/interdependency of manufacturing support departments.
- You will have knowledge of manufacturing equipment operation, including set up and changeover, and commissioning, validation, and troubleshooting.
- Basic scientific understanding of biology and chemistry/ biochemistry as it applies to the manufacturing process.
- May have more specific skills in areas depending on need/ opportunity: Aseptic technique, Vial Washing, CIP/SIP, Lyophilization operations.
- You will have Knowledge of clean room manage ment.
- You will prepare and write technical reports.
- Proficient in PowerPoint, Word, Excel (can maintain complex spreadsheets), Access.
What you bring to Takeda:
- You will have a Bachelor's degree in scientific or engineering field preferred with 3 or more years of related manufacturing experience, or AA degree with 5-7 years of related manufacturing experience, or HS diploma with 7 to 10 years of related 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
At 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:
- The physical exertion of this role is medium to heavy work.
- May be required to gown frequently and balance when gowning into clean areas.
- May work at heights above floor level.
- May sit or squat between 1-2 hours.
- May climb (use step stools and ladders) or kneel up to 1 hour.
- Requires repetitive use of right/left hands and arms and may require reaching above/below the shoulder up to 3-4 hours.
- May twist at the waist up/twist at the neck up to 1 hour
- May lift to 50lbs; Lifts per shift are up to 100 times.
- May carry up to 50lbs; Carry distance of up to 6 feet; Carry per shift are up to 100 times.
- May require simple grasping and pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours.
- May work in a confined area as defined by the Environmental, Health, and Safety office.
- May work with biohazards such as: bloodborne pathogens or medical waste.
- Will require entering a 2-8 degree Celsius and -60-degree Celsius freezer to store and retrieve materials and multiple chemicals to support mfg such as IPA, 500ppm sodium hypochlorite.
- May work in a cold, wet environment or cool/hot storage conditions; may work with dust, gasses, and fumes; may work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
- May require the use of special visual or auditory protective equipment.
- May be around and operating moving equipment and machinery.
- May climb up and into large processing tanks for cleaning or inspection.
- Will work 4 days a week, 10 hours a day.
- May be required to more than a 40-hour work week.
- Requires weekend and holiday work
- May be available after hours And on call.
- May work or be assigned to a different shift.
- 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 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 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.
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.