- Responsible for the direct oversight of personnel and daily manufacturing activities of assigned area in a cGMP Biologics manufacturing facility
- Ensure employees are performing all tasks according to SOP s, applying cGMP practices and are working in a safe manner
- Actively participate in the coaching, training and development of employees
- 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 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, log books 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
- 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
- Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Preferred combination of education and experience:
- Bachelor s Degree in science or Engineering and 4 or more years of experience in a GMP environment; or
- Associate s Degree in Science or Engineering 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
Knowledge, competencies and skills:
- 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 team and detail-oriented and able to work in a fast-paced environment
- Possess excellent written and oral communication skills.
- Proficient in MS Office and related PC skills
- Must have passion to innovate and drive for solutions.
- Must have excellent planning and organizational skills.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
- 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.
OTHER / TRAVEL REQUIREMENTS:
- Must have the ability to work on assigned shift (Day or Night)
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
- On rare occasions, travel may be required to offsite meetings or training event
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA
ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role
Brooklyn Park, MN