Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manufacturing Supervisor in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Supervisor working on the Biologics Manufacturing team, you will be empowered to use your cGMP knowledge while overseeing production processes, and a typical day will include:
The Manufacturing Supervisor is responsible for the direct oversight of a cGMP Biologics manufacturing operation assuring compliance with safety and cGMP requirements while adhering to the manufacturing schedule. He/she coordinates training and development of Manufacturing Associates, leads/ supports deviation investigations and safety incident investigations. Analyze staffing needs and make appropriate staffing adjustments
- Oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule.
- Performs/assists with Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system
- Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records, SLRs, and equipment logbooks.
- Coordinate training and development of Manufacturing Associates.
- Reviews Manufacturing documentation on a daily basis
- Coordinate Facilities, Metrology, Validation, Product Development and other non-routine activities with the manufacturing schedule.
- Provide leadership support during trouble shooting of equipment, operation and processes
- Conduct annual performance reviews of direct reports
- Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives
- Leads/ supports deviation initiation, investigations and closure. Participates in cross functional project teams, supports technical transfers with relevant teams/ individuals.
- Excellent knowledge of current Good Manufacturing Practices (cGMP s). Working knowledge of all relevant safety procedures within the company. Excellent understanding of most areas in Manufacturing and supporting functional groups.
- Excellent understanding of cGMP Biotech or Pharmaceutical operations
- Understands cGMP requirements and follows those requirements, including requirements for good documentation practices.
- Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
- Possess excellent knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
- Possess an excellent understanding of the scientific theory of biologics manufacturing: Has an excellent understanding of biotechnology processing - purpose of major unit operations and microbial control concepts
- Actively pursues learning of required skills, new skills, and new equipment
- Understand routine procedures upon which they have been trained, is able to revise and create new procedures/documents.
- Possess excellent equipment understanding, including understanding equipment function and application.
- Proficient and knowledgeable in the operation and complex troubleshooting of multiple manufacturing areas
- Ability to train less experienced manufacturing associates.
- Lead/ supports deviation investigations. Participates in cross functional project teams, supports technical transfers with relevant teams/individuals.
- Analyze department performance and proactively identify and implement strategies to improve
Bachelor s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 4-8 years relevant experience and 2+ years supervisory experience, or Associate s Degree in a scientific or engineering discipline with a minimum of 6+ years related experience and 4+ years supervisory experience, or High School Diploma with a minimum of 8+ years relevant experience and 6+ years supervisory experience.
- Required to stand, operate manufacturing equipment, computer equipment; and is required to wear personal protective equipment (PPE) such as safety shoes, safety glasses and/or hearing protection.
- 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.
- May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
- May be required to drive rarely to attend offsite meetings and/or training.
- May be required to use hearing occasionally when listening for production and equipment alarms.
- Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
- May be required to perform visual inspection of production equipment, materials, and activities.
- May be required to perform occasional overhead reaching during handling of production materials/files/supplies.
WHAT TAKEDA CAN OFFER YOU:
To further support and inspire our employees, our benefits include:
- Company-paid volunteer days
- Company match of charitable contributions
- 401(k) with company match, and annual retirement contribution plan
- Adoption assistance and tuition reimbursement program
Empowering Our People to Shine
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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