Manufacturing Manager (Cell Therapy, CDMO)

JOB SUMMARY

Cellipont Bioservices is growing, and we are looking for aManufacturing Manager 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 Manager of Manufacturing will be responsible in leading a team of manufacturing associates, leads and supervisors while overseeing the coordination and execution of GMP manufacturing for early phase products.

The Manager, Manufacturing is also responsible for ensuring all personnel activities are executed timely and cost effectively to insure 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 successful manufacture of client processes
• Responsible for training manufacturing personnel on the use of the Batch records, scheduling, setting up production batches, requesting materials, aseptic processing and GDP/GMP.
• Ensure batches adhere to established Quality standards; GMP batch review and close-out with Quality Assurance group.
• Supports tech transfer of process from client to GMP manufacturing.
• Conduct interviews and provide input for hiring new manufacturing personnel.
• Provide daily production updates to production managers, client representatives, and project managers.
• Provide guidance for continuous improvement initiatives within the Manufacturing team.
• Work with Manufacturing, Quality, Engineering and Supply Chain groups on issues and identifies process improvement opportunities.
• Identify and support the implementation of process efficiencies and areas for improvement
• Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate.
• Analyze staffing requirements and responsibilities related to business needs and forecasts.
• Employee performance evaluations (job role capabilities assessment), new employee hiring, disciplinary notices, employee termination, according to company guidelines and performance requirements.
• Develop and manage individual contributor employees to drive high performing culture.
• Ability to direct, supervise, and influence exempt, non-exempt employees who are not direct reports.
• Foster a people first and right first-time culture
• Perform additional duties as needed

The Candidate

• Bachelor's Degree - Life Sciences or Chemical Engineering and minimum 5+ years in GMP environment with experience in GMP manufacturing operations/Cell Therapy/Human Cell Culture. CDMO experience preferred.
• Direct people management/leadership experience minimum of 3+ year's experience
• Aseptic processing experience is required 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

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

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