Manufacturing Supervisor (Cell Therapy CDMO)

Summary

Cellipont Bioservices is growing, and we are looking for aManufacturing Supervisor who believes in the potential bridging of client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level.

The Manufacturing Supervisor will provide hands-on direction for manufacturing personnel and activities. This position requires extensive technical expertise in aseptic techniques. Provide expertise in writing/reviewing SOPs, Batch Records, Deviations, CAPA's and other technical document/compliance documents as it relates to the Manufacturing Operations. The Manufacturing Supervisor is also responsible for ensuring all personnel activities are executed timely and cost effectively to ensure customer and stakeholder satisfaction. This role will also require the individual to demonstrate strong customer service capability, ability to work cross-functionally and possess strong leadership skills.

The Role

• Oversee and schedule the manufacturing operations and personnel
• Leads a manufacturing team to identify issues and propose adequate solutions
• Responsible for training manufacturing personnel on the use of the Batch records, scheduling, ordering of raw materials, components and supplies, setting up production batches, and maintaining inventory
• Ensure batches adhere to established Quality standards
• GMP batch review and close-out with Quality Assurance group
• Conduct interviews and provide input for hiring new manufacturing specialist.
• Provide daily production updates to production managers, client representatives, and project managers
• Provide guidance for continuous improvement initiatives within the Manufacturing team
• Represent the department to clients and on cross-functional project teams
• May operate production equipment and inspect, label, or package products
• Work with Manufacturing, Quality, Engineering and Technology groups on issues and identifies process improvement opportunities
• Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
• Identify and support the implementation of process efficiencies and areas for improvement
• Ensures solutions are consistent with organization's objectives
• Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate
• Perform additional duties as needed

The Candidate

• Bachelor's Degree - Life Sciences or Chemical Engineering and minimum 5 - 7 years in GMP environment with experience in GMP manufacturing operations/Cell Therapy/Human Cell Cultivation. CDMO experience preferred.
• 3 years minimum of leadership/management experience in a GMP environment
• Experience in writing, executing and reviewing SOPs / MBRs while maintaining proper GDP guidelines.
• Good mechanical aptitude, familiar with general equipment associated with Cell and Gene Therapy Processing.
• Detail oriented and highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment
• Must be proficient in Word and Excel.
• Ability to interpret process trends and data and react appropriately to unexpected outcomes.
• Innovative spirit, strong initiative and work ethic, and positive attitude
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines
• Must be available to work 2nd shift (2:00 PM – 11:00 PM), Monday through Friday, with occasional weekend or holiday support as needed

Work Environment

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to work off-shift and extra hours as required
• Weekends & Holidays as required

POSITION BENEFITS

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space