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Job Description
About the role:
As a Manufacturing Supervisor, you will have direct oversight of personnel and daily manufacturing activities of assigned area in a cGMP Biologics manufacturing facility. You will oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule. You will report to the Manager, Manufacturing.
The shift for this position is 5:45PM - 6:15 AM on a 2-2-3 schedule.
How you will contribute:
Ensure employees are performing all tasks according to SOP's
Participate in the coaching, training, and development of employees.
Performs/assists with Processing Steps and/or manufacturing support activities by monitoring process parameters in batch records and control systems.
Documents/Records cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, SAP data entry, and equipment logbooks.
Coordinate and actively participate in the training and development of Manufacturing Associates.
Reviews Manufacturing documentation daily (BPR's, logbooks etc.)
Coordinate Facilities, Metrology, Validation, Product Development, and other non-routine activities with the manufacturing schedule.
Provide oversight of support groups when working with manufacturing systems.
Provide leadership support during trouble shooting of equipment, operation, and processes.
May revise and/or create new procedures/documents.
May support and/or complete deviation invetigations.
Conduct annual performance reviews of direct reports.
Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives.
Lead / support deviation initiation, investigations, and closure. Participate in cross functional project teams, supports technical transfers with relevant teams/ individuals.
Analyze staffing needs and make appropriate staffing adjustments/recommendations.
Complete mandatory training within required timeframe.
What you bring to Takeda:
Bachelor's Degree (scientific or engineering degree preferred) and 4 or more years of experience in a GMP environment; or
Associate degree (scientific or engineering degree preferred) and 6 or more years of experience in a GMP environment; or
High School Diploma or GED and 8 or more years of experience in a GMP environment.
Previous supervisory experience highly preferred.
Biotech or Pharmaceutical experience preferred.
Demonstrated application of current Good Manufacturing Practices (cGMP's) and Good Documentation Practices (GDP).
Advanced understanding of cGMP Biotech or Pharmaceutical operations a plus.
Proficient and knowledgeable in the operation and complex troubleshooting of multiple manufacturing areas (i.e., downstream, upstream and/or media buffer).
Has some knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
Advanced understanding of the scientific theory of biologics manufacturing and of biotechnology processing.
Possesses manufacturing equipment understanding, including equipment function and application.
Ability to analyze department performance and proactively identify and implement strategies to improve.
Ability to train and develop direct reports.
Must be detail-oriented and able to work in a team in a fast-paced environment.
Possess excellent written and oral communication skills.
Proficient in MS Office and related PC skills.
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:
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/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus).
May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
May be required to perform occasional overhead reaching during handling of production materials/files/supplies.
Must have the ability to work on assigned shift (Day or Night).
On rare occasions, travel may be required to offsite meetings or training event.
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 #LI-MA1
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:
Brooklyn Park, MN
U.S. Base Salary Range:
$89,900.00 - $141,240.00
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
Brooklyn Park, MN
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
