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.
Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Knowledge, competencies and skills:
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).
Possesses excellent knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
Possesses an excellent understanding of the scientific theory of biologics manufacturing: Has a 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.
Possesses 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 or new 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
Proficient in MS Office and related PC skills
Must have the ability to work either Day or Night shift.
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.
On rare occasions, travel may be required to offsite meetings or training event
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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