MSAT - Director Manufacturing Sciences and Technology

Minaris•Allendale, NJ

About The Position

The Director of Manufacturing Sciences and Technology provides strategic and technical leadership for the MSAT organization, overseeing clinical and commercial manufacturing support, client program execution, technology transfer, process performance, validation readiness, product lifecycle management, and continuous improvement. The role ensures robust manufacturing processes, successful client delivery, strong customer partnerships, and organizational readiness for commercial growth and expansion. Working with clients and teams across Process Development, Analytical Development, Manufacturing, Quality, Regulatory, Engineering, and Supply Chain, the Director translates scientific knowledge into practical manufacturing strategies, risk-based decisions, and sustainable commercial performance. The Director leads MSAT strategy, technical input for new business opportunities, client relationships, CMC strategies, technology transfers, commercial readiness, and operational excellence. The role also develops a high-performing MSAT organization through workforce planning, succession planning, mentoring, career development, and training. It requires compliance with quality and safety requirements, regular full-time attendance, professional conduct, and alignment with company values. The position supports biopharmaceutical manufacturing and laboratory testing facilities and may allow remote work. Travel may be required up to 25%, including local and occasional overnight travel. Off-shift, weekend, holiday, and overtime duties may be required.

Requirements

Master’s or PhD degree in Engineering, Biotechnology, Life Sciences, or a related discipline.
At least 10 years of experience, including 5 or more years of relevant experience in the cell and gene-related field.
Experience working in a GMP environment.
Significant biopharmaceutical manufacturing/MSAT experience with increasing leadership responsibility; CDMO experience is preferred.
Experience with commercial programs and delivering client programs and supporting commercial manufacturing expansion.
Strong knowledge of technology transfer, validation (PPQ), CPV, GMP operations, and regulatory expectations.
Deep knowledge of biopharmaceutical manufacturing processes, preferably cell therapy, gene therapy, or advanced therapies.
Strong understanding of GMP regulations, ICH guidelines, FDA/EMA expectations, and validation lifecycle principles.
Expertise in technology transfer, comparability strategy, PPQ, CPV, and lifecycle process management.
Proficiency in risk-management tools, including FMEA, root cause analysis, CAPA, and change-control systems.
Analytical capability and experience with statistical trending, data visualization, and process-monitoring tools.
Ability to lead complex cross-functional programs in a fast-paced client-service environment.
Business acumen and understanding of CDMO operations, client contracts, timelines, and deliverables.
Excellent verbal, written, and presentation skills for communication with clients and executive leadership.
Proven negotiation, influencing, and conflict-resolution skills.
Ability to prioritize multiple programs while maintaining quality and execution standards.
Leadership capability in coaching, developing, and retaining high-performing technical teams.
Demonstrated leadership in investigations, process troubleshooting, and cross-functional collaboration.
Client-facing presence and experience managing external partnerships.
Ability to travel up to 25%, including local and occasional overnight travel; off-shift, weekend, holiday, shift-work, and overtime duties may be required.
Ability to comply with safety training, procedures, and PPE requirements when entering areas with biological, chemical, or other hazards.
Ability to sit for extended periods (4–6 hours with breaks), reach, bend, and lift light materials (typically under 20 lbs), read documents and screens, hear verbal communication, use a computer and office equipment, type, handle papers, and perform keyboard navigation.

Nice To Haves

CDMO environment experience.
Cell therapy, gene therapy, or advanced-therapy manufacturing experience.

Responsibilities

Provide strategic leadership and direction for MSAT, aligning technical priorities with business strategy, client programs, and long-term growth objectives.
Lead technical strategy and input for new business opportunities, proposals, RFP responses, due diligence, and technology assessments.
Partner with Business Development, Commercial, Process Development, Manufacturing, Quality, Regulatory, and Finance to develop competitive, executable proposals.
Evaluate technical feasibility, manufacturing readiness, capacity requirements, and process risks for prospective programs.
Represent MSAT in client presentations, technical discussions, governance meetings, strategic partnerships, steering committees, and technical reviews.
Build client relationships and translate their technical, operational, regulatory, and commercial objectives into program execution strategies.
Provide CMC and MSAT leadership for process optimization, clinical and commercial manufacturing, technology transfer, validation strategy, and commercial launch.
Lead technology transfers for new products, process changes, scale-up, and site-to-site transfers, ensuring effective knowledge transfer and manufacturing implementation.
Provide technical oversight of Process Development and Analytical Development deliverables to ensure processes, methods, and control strategies are developed, characterized, documented, and ready for GMP manufacturing.
Develop and execute CMC strategies covering process characterization and optimization, comparability assessments, validation, regulatory readiness, and product lifecycle management.
Lead PPQ, CPV, FMEA risk assessments, and advanced process monitoring strategies.
Use data science, AI-assisted predictive analytics, and digital tools to improve process understanding, identify risks, and enable proactive process control.
Lead commercial readiness, including launch planning, campaign readiness, sustained supply strategies, and resolution of manufacturing challenges.
Support capacity expansion and network growth through facility-fit assessments, equipment readiness, scalability evaluations, and operational readiness planning.
Drive operational excellence through structured problem solving, deviation management, CAPA effectiveness, continuous improvement, and cross-functional collaboration.
Establish clear communication across MSAT, manufacturing sites, clients, and cross-functional organizations; facilitate alignment across global teams.
Promote collaboration, accountability, trust, problem solving, and customer success.
Build and develop a high-performing MSAT organization with strong technical expertise, leadership capability, and a customer-focused mindset.
Define organizational capabilities, workforce strategies, and succession plans to support current operations and future growth.
Mentor and coach technical leaders and team members, and establish career development frameworks, competency models, and training programs.
Attend reliably on a full-time basis and exhibit professional behavior consistent with company policies and values.
Support a diverse and inclusive culture; ensure compliance with laws, regulations, and company policies; identify, recruit, and retain talent.
Set performance standards and support employee engagement and development through delegation, feedback, goal setting, and performance management.
Maintain transparent communication, confidentiality, ethical conduct, and strong customer relationships; adapt to ambiguity and change.
Ensure compliance with FDA and worldwide quality and compliance regulations, established procedures and protocols, training requirements, and data-integrity standards.
Perform other duties as assigned.