Director, Manufacturing Science & Technology

Job Summary

Cellipont Bioservices is growing, and we are looking for a Director, Manufacturing Science & Technology who believes in the potential of bridging 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 Director, Manufacturing Science & Technology (MS&T), is responsible for leading a high-performing technical team to ensure successful execution of client deliverables and commercial manufacturing support. This role provides strategic and operational leadership across technology transfer, process optimization, scale-up, process validation, and lifecycle management of manufacturing processes.

The Director, Manufacturing Science & Technology (MS&T), will drive continuous improvement initiatives, enhance process robustness and efficiency, and ensure compliance with regulatory standards. This position requires strong cross-functional collaboration and technical expertise to support both clinical and commercial programs while contributing to overall organizational performance. 

The Role

• Develop and implement a comprehensive MS&T strategy aligned with the company's overall objectives and business priorities
• Ensure all MS&T activities comply with applicable regulatory requirements, including FDA, cGMP, and global regulatory standards
• Lead technology transfer and manufacturing strategy implementation, including process optimization, scale-up, validation, and commercial readiness
• Develop and manage the MS&T budget, ensuring effective allocation of resources and cost-efficient execution of activities
• Champion a culture of teamwork, accountability, continuous improvement, and transparent communication across the organization
• Lead a team of MS&T professionals responsible for all aspects of product transfer from process establishment through cGMP manufacturing
• Build, develop, and mentor a high-performing MS&T team, fostering collaboration and technical excellence
• Collaborate cross-functionally to ensure seamless integration of new processes, technologies, and equipment into manufacturing operations
• Own execution of the technology transfer portfolio and provide ongoing technical support for routine manufacturing.
• Partner across functions to provide technical expertise in the design and development of robust, scalable, and compliant manufacturing processes
• Collaborate with PM and IT functions to implement advanced technologies for data analysis, digitalization, and process monitoring
• Conduct in-depth analysis of existing manufacturing processes, identifying opportunities for improvement and implementing effective solutions
• Design and execute process optimization strategies to enhance efficiency, reduce cycle times, and improve product quality
• Stay current with advancements in process engineering, manufacturing technologies, and industry best practices
• Other duties as assigned

The Candidate

• Bachelor's Degree, Masters preferred - Life Sciences or Chemical Engineering and minimum 8+ years in GMP environment with experience in GMP manufacturing operations/Cell Therapy CDMO experience preferred.
• Direct people leadership experience minimum of 7+ years' experience  
• Aseptic processing experience is required in a GMP environment  
• Experience in writing, executing, and reviewing SOPs / MBRs while maintaining proper GDP guidelines.
• Must be highly motivated, detail oriented, 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.  
• Demonstrate ability to mentor, train, motivate, direct and empower direct reports with proven track record of driving results and change management through excellent communication skills and leadership ability  
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.  

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

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.