General Summary and Purpose:

The Manufacturing Supervisor is a core team member of the Manufacturing Department. The Manufacturing Supervisor is responsible for monitoring and ensuring the day-to-day staff in executing the manufacturing processes in compliance with established SOPs. This position is accountable for the efficient operation of the manufacturing processes, collaborating with supervisors/team leads from multiple shifts to ensuring accuracy of production and performing troubleshooting activities as needed. The right candidate will exhibit the initiative and drive to accomplish departmental and company objectives while maintaining the highest quality standards.

Duties and Responsibilities:

60-70% of job duties will include management and indirect manufacturing support projects. This includes but is not limited to:

• Oversee clean room activities; ensuring team members adhere to work instructions and SOPs.
• Monitor and ensure team members follow proper aseptic technique and appropriate cleanroom behavior.
• Perform periodic 1 on 1s and performance reviews for team members.
• Develop/mentor team members to perform to expectations.
• Ensure all documentation in accordance to BioLife's Quality Management System is properly requested, completed, and filled out on time. This includes batch records, forms, log sheets, deviations, CAPAs etc.
• Effectively address daily production issues and escalate issues to management if necessary.
• Update or direct the updates of master documentation as needed.
• Responsible for establishing and maintaining tracking metrics for critical processing steps in order to anticipate problems real time.
• Responsible for scheduling all aspects of daily production to ensure proper team member rotations and adequate staff coverage for MFG activities.
• Ensure completion of pre-production suite set up cleaning and post-production cleaning and documentation.
• Oversee activities on the production floor ensuring all team members comply with Aseptic technique, SOPs, batch records and safety policies.
• Review production records for accuracy.
• Maintain open communication with Department Head to streamline flow of operations and effectively address daily production issues.
• Manage the training and development of additional production team members to maintain a fully staffed.
• Oversee manufacturing materials inventory control and inventory maintenance and qualified cross functional manufacturing department.
• Perform preventive maintenance on manufacturing equipment.
• Perform root cause investigations for Quality issues.
• Perform validation activities as needed.
• Perform batch record and SOP revisions.
• Proposes champions and implements process improvements.
• Supports training program sharing knowledge of process.
• Training new manufacturing team members and be a source of knowledge and information.
• Lead cross departmental projects
• Other projects and duties as required.

30-40% of job duties will be directly related to routine processes of bulk formulation, filling, and environmental monitoring sampling Quality System regulated compliant media products. This includes but is not limited to:

• In-process review ensuring operators are accurately documenting procedures in Batch Records, Logbooks, and GMP documentation.
• In-process review ensuring operators are accurately documenting procedures in Batch Records, logbooks, and GMP documentation real time.
• Disinfecting and transferring materials and equipment into the cleanroom for production
• Working inside cleanroom suites on your feet for several hours at a time
• Perform environmental monitoring.
• Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Aseptically fill solutions into finished product containers under sterile conditions
• Perform washing of labware used in GMP manufacture.
• Perform cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical surfaces, and floors)
• Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
• Operate equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes.
• Perform all tasks while follow all SOPs, batch records, and safety policies.
• Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation
• May be required to work either day or evening shift as needed.
• May occasionally be required to work weekends and overtime as needed.
• Required to be on-call for equipment monitoring on a rotation.
• Duties, responsibilities, and activities may change at any time with or without notice.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Reporting Relationships:

Oversee a team of manufacturing technicians. This position reports to Manufacturing Manager.

Job Requirements:

• Bachelor's degree and 4 years of relevant experience; or Associate degree / Biotech cert and 5 years of relevant experience; or High school diploma / GED and 6 years of relevant experience
• 1+ year of supervisory experience
• Ability to manage and develop team members.
• Ability to diagnose and solve problems in a fast-paced environment.
• Ability to support manufacturing team needs and effectively communicate to management.
• Self-motivated and willing to accept temporary responsibilities outside of normal job duties.
• Comfortable working in a fast-changing small company environment and able to adjust workload based on changing priorities.
• Must not have unusual sensitivity to typical laboratory chemicals (i.e., sanitization agents)
• Must be able to perform fast paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy.
• Effectively communicate while wearing cleanroom gowning (mask, hood, coveralls, gloves, etc.)
• Must be able to work effectively in a group and independently.
• Must be able to meet aseptic gowning qualification requirements.
• Must be able to work regularly with cleaners.
• Must be able to lift up to 50 lbs. and push/pull up to 1200 lbs. with assistance.

Job Specifications:

• Leadership experience is needed.
• Prior aseptic processing experience in a cGMP/FDA regulated environment is needed.
• Prior cleanroom gowning experience is needed.
• Familiarity with Lean/Six Sigma/5S is desirable.
• Degree in sciences with an interest in pharmaceutical manufacturing is desirable.
• Familiarity with Microsoft Office programs (Word, Excel, Outlook) is desirable.
• May be required to work either day or evening shift.
• May occasionally be required to work weekends and overtime.

The US base salary range for this position at full-time is $75,513 - $ 105,719 per year. Typically, new hires are brought in at or near the midpoint of the range to allow for future growth and advancement within the role. This range represents the full compensation range for this position, with consideration given to experience, skills, and qualifications. Our salary ranges are determined by position, level, location, and market competitive benchmarks. Individual pay within a level is determined by work location (including geographic pay zone region), job related skills, experience, education, and training.

The BioLife Solutions total rewards program includes, but is not limited to medical, dental, vision, 401K with generous match, life and disability insurance as well as time off programs of Vacation and Sick time. Additionally, we believe in our team members sharing the success of our business and therefore we may provide cash bonus or stock equity grants based on company performance as a part of our total rewards package.