Director MS&T
Cellipont, The Woodlands, TX, United States
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!"
#J-18808-Ljbffr
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!"
#J-18808-Ljbffr