•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 (BPR's, .LB's 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
•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.
Qualifications 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.
•Has an excellent understanding of cGMP Biotech or Pharmaceutical operations
•cGMP: 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 written and oral communication skills.
•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 area's
•Ability to train less experienced or new manufacturing associates.
•Lead/ supports deviation investigations. Participates in cross functional projects 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.
•IRequired 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
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