Proclinical is currently recruiting for a Manufacturing Supervisor for a global pharmaceutical company located in Brooklyn Park, MN. Successful candidate will be responsible for the direct oversight of personnel and daily manufacturing activities of assigned area in a cGMP Biologics manufacturing facility
- 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.)
- 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.
- 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.
Skills and Requirements:
- 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.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.