Job Information
Takeda Pharmaceuticals Manufacturing Supervisor- Drug Product in Thousand Oaks, California
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Job Description
Job Title: Manufacturing Supervisor- Drug Product
Location: Thousand Oaks, CA
About the role:
The Manufacturing Supervisor- Drug Product implements and manages the Formation/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 Drug Product Operations Manager.
How you will contribute:
Provide leadership and oversight of approximately 10-15 direct reports.
Build a team, provide training and ongoing coaching, discipline, and recognition of staff, including annual performance reviews.
Manage the day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities.
Improve the AGILE (Business Excellence) operating system (AOS) with a focus on meeting the Master Production Schedule and Lead Time for all products.
Responsible for owning Tier I AOS board to drive continuous improvement.
Oversee on the floor 50% of the time.
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.
Provide input into integration and validation of new equipment and process.
Resolve technical, material, and cGMP issues.
Review, approve, and manage documentation for batch and system records for production.
Interface 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, assist with training and auditing.
Participate in Internal or external audits as SME for department.
Expertise in influencing a team.
Knowledge of Formulation, Filling and Capping manufacturing operations, including lean manufacturing.
Knowledge of Utility Systems and how they impact the Manufacturing Departments.
Understand the flow and design/interdependency of manufacturing support departments.
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 skill sets in areas depending on need/ opportunity: Aseptic technique, Vial Washing, CIP/SIP, Lyophilization operations, etc.
Knowledge of clean room management.
What you bring to Takeda:
Bachelor's degree in scientific or engineering field preferred with 3+ years of experience, or AA degree with 5+ years of manufacturing experience, or HS diploma with 7+ years of manufacturing experience.
Minimum of 2 years of leadership experience preferred.
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 be required to work at heights above floor level.
May be required to sit or squat between 1-2 hours.
May be required to climb (use step stools and ladders) or kneel up to 1 hour.
Requires repetitive use of right/left hands & arms and may require reaching above/below the shoulder up to 3-4 hours.
May be required to walk, stand, or bend at the neck/waist for over 4 hours.
May be required to twist at the waist up/twist at the neck up to 1 hour.
May be required to lift to 50lbs; Lifts per shift are up to 100 times.
May be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times.
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 work in a confined area as defined by the Environmental, Health, & Safety office.
May be required to work with biohazards such as: bloodborne pathogens 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 such as IPA, 500ppm sodium hypochlorite.
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 in a cold, hot or wet environment.
May work around chemicals such as alcohol, acids, buffers and Celite 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.
Able to work 4 days a week, 10 hours a day.
May be required to more than a 40-hour work week.
Requires weekend and possibly holiday work.
May be required to be available after hours and/or on call as needed.
May be required to work or be assigned to a different shift as needed.
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.
#GMSGQ
#ZR1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CA - Thousand Oaks - Rancho Conejo
U.S. Base Salary Range:
$84,000.00 - $132,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
Takeda Pharmaceuticals
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