Manufacturing Manager (Cell Therapy, CDMO)

Cellipont Bioservices • The Woodlands, TX

5d

About The Position

Cellipont Bioservices is seeking a Manufacturing Manager who is passionate about advancing cell therapies from discovery to patient cures and challenging the status quo. The Manager of Manufacturing will lead a team of manufacturing associates, leads, and supervisors, overseeing GMP manufacturing for early-phase products. This role is crucial for ensuring timely and cost-effective execution of all personnel activities to achieve customer and stakeholder satisfaction. The ideal candidate will possess strong customer service skills, the ability to collaborate cross-functionally, and excellent leadership qualities.

Requirements

• Bachelor's Degree in Life Sciences or Chemical Engineering.
• Minimum of 5+ years in a GMP environment.
• Experience in GMP manufacturing operations/Cell Therapy/Human Cell Culture.
• Direct people management/leadership experience of a minimum of 3+ years.
• Aseptic processing experience in a GMP environment is required.
• 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.
• Ability to follow oral and written instructions.
• Ability to communicate effectively.
• Ability to think logically.
• Ability to thrive independently and/or in a fast-paced team environment.
• Proficiency in Word and Excel.
• Ability to interpret process trends and data and react appropriately to unexpected outcomes.
• Innovative spirit, strong initiative, and work ethic.
• Positive attitude.
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.

Nice To Haves

• CDMO experience preferred.

Responsibilities

• Oversee and schedule manufacturing operations and personnel.
• Lead a manufacturing team to successfully manufacture client processes.
• Ensure batches adhere to established Quality standards, including GMP batch review and close-out with the Quality Assurance group.
• Support the tech transfer of processes from clients 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 identify process improvement opportunities.
• Identify and support the implementation of process efficiencies and areas for improvement.
• Establish performance standards, employee coaching and development, determine employee responsibilities, evaluate performance, and reward as appropriate.
• Analyze staffing requirements and responsibilities related to business needs and forecasts.
• Conduct employee performance evaluations, manage new employee hiring, issue disciplinary notices, and handle employee terminations according to company guidelines.
• Develop and manage individual contributor employees to drive a high-performing culture.
• Direct, supervise, and influence exempt and non-exempt employees who are not direct reports.
• Foster a people-first and right-first-time culture.
• Perform additional duties as needed.

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
• Paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Manager