Manufacturing Supervisor - Cell and Gene Therapy (Swing Shift) *PC 1521

Your Role:

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to oversee and participate in day-to-day GMP processes and production activities for the manufacturing team at our facility. The unique duties of this position will primarily consist of training and managing the performance of the Manufacturing (MFG) Cell and Gene Therapy (CGT) GMP staff while supporting the development of scalable processes.

Furthermore, you will be responsible for developing documentation, reviewing/creating/adhering to MFG schedules, monitoring the maintenance of production equipment and investigating all failures to support the GMP manufacturing suites, equipment and facility operations.

Overall, your ability to drive continuous improvement in a GMP controlled environment while motivating and collaborating across diverse disciplines will champion the continued development of Miltenyi Biotec products and growing success.

Essential Duties and Responsibilities:

• Performing and coordinating day to day activities across shifts with peers and manufacturing staff; generating end of shift reports/escalation; maintaining cleanroom presence; resolving or provide resolutions to manufacturing process issues.
• Authoring, reviewing, revising and approving Batch records, SOPs, Manufacturing Change Control, and CAPAs.
• Coordinating APS/APQ, clinical and commercial manufacturing schedules, semi-annual PM and calibration for manufacturing equipment.
• Implementing GDP and GMP, continuous improvement Initiatives, 5S and lean manufacturing.
• Working closely with the manufacturing team in creating and implementing Manufacturing/Operators Standard ways of working in accordance to Quality, Safety and Data integrity.
• Collaborate with Facility Maintenance, Validation and QA with commissioning and start up activities.
• Responsible for interviewing/hiring; training; mentoring, developing and reviewing performance to strengthen and grow a manufacturing team. *
• Manage, review and approve Manufacturing Associates individual schedules, goals, and timesheets.

Requirements:

• Bachelor's degree in biological science, Engineering or related discipline; Minimum of 4 - 5 years in Manufacturing with a minimum of 1 year in a supervisory role managing a team of manufacturing associates in a cGMP pharmaceutical aseptic manufacturing facility; or equivalent combination of education and experience.
• Experience with production support activities such as media and buffer preparations, clinical or commercial Cell and Gene Therapy (CGT) production, aseptic processing of Apheresis, CGT upstream and downstream process that includes but not limited to aseptic sampling, on the floor sample analysis, filtration, final fill.

Knowledge:

• Strong Technical and Process knowledge in field of Cell and Gene Therapy Manufacturing.
• Knowledge in SAP or similar ERP system is a plus.
• Knowledge and/or use of electronic batch records is a plus.
• 2+ years of clinical processing with a Prodigy is desired.
• Technical experience with Single use technology (welds/seals) is desired.

Skills:

• Demonstrated ability to effectively collaborate with cross-functional and global multi-location teams.
• Ability to adapt in a fast-paced environment.
• Proven ability to motivate, mentor, coach and lead manufacturing staff.
• Must have excellent computer skills; verbal and written communication skills at all levels; quality mindset, be a team player, have a can do attitude, be a fast learner, and have strong decision-making ability.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $88,100-$103,650/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.