Full Job Description
Position Summary
Provides strategic and technical leadership for Manufacturing Science and Technology, overseeing clinical and commercial manufacturing support, client program execution, technology transfer, process performance, process validation readiness, product lifecycle management, and continuous improvement. This role ensures robust manufacturing processes, successful client delivery, strong customer partnerships, and organizational readiness for commercial growth and expansion. Working closely with clients and partners across Process Development (PD), Analytical Development (AD), Manufacturing, Quality, Regulatory, Engineering, and Supply Chain, the Head of MSAT ensures that scientific knowledge is translated into practical manufacturing strategies, sound risk-based decisions, and sustainable commercial performance.
Essential Functions and Responsibilities
• Provide strategic leadership and direction for the MSAT organization, aligning technical priorities with Minaris' business strategy, client programs, and long-term growth objectives.
• Lead technical input and strategy development for new business opportunities, including client proposals generation, RFP responses, due diligence activities, and technology assessment packages.
• Partner closely with Business Development, Commercial, Process Development, Manufacturing, Quality, Regulatory, and Finance teams to develop competitive and executable proposals.
• Evaluate technical feasibility, manufacturing readiness, capacity requirements, and process risks for prospective programs to enable informed business decisions.
• Represent MSAT in client presentations, technical discussions, governance meetings, and strategic partnership engagements.
• Build strong client relationships by understanding technical, operational, regulatory, and commercial objectives and translating them into successful program execution strategies.
• Provide strategic CMC and MSAT leadership to support process optimization, clinical and commercial manufacturing, technology transfer, validation strategy, and commercial launch across the Minaris network.
• Lead end-to-end technology transfer activities for new client products, process changes, scale-up, and site-to-site transfers, ensuring effective process knowledge transfer and successful manufacturing implementation.
• Provide technical oversight of PD and AD deliverables to ensure processes, analytical methods, and control strategies are appropriately developed, characterized, documented, and ready for transfer into GMP manufacturing
• Develop and execute CMC strategies, including process characterization, optimization, comparability assessments, validation strategies, regulatory readiness, and product lifecycle management plans.
• Lead PPQ, CPV, FMEA risk assessments, and advanced process monitoring strategies to ensure robust, compliant, and scalable manufacturing processes.
• Establish data-driven manufacturing capabilities by leveraging data science, AI-assisted predictive analytics, and digital tools to enhance process understanding, identify emerging risks, and enable proactive process control.
• Lead commercial readiness activities, including launch planning, campaign readiness, sustained supply strategies, and rapid 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 with PADi, Manufacturing, Quality, Supply Chain, Engineering, and IT teams.
• Establish clear, effective, and transparent communication across MSAT, manufacturing sites, clients, and cross-functional organizations.
• Build strong partnerships with PADI, Manufacturing, Quality, Supply Chain, Engineering, and IT teams to enable seamless program execution.
• Represent MSAT in governance meetings, client steering committees, technical reviews, and critical decision-making forums.
• Facilitate alignment across global teams by translating complex technical information into clear strategies, priorities, risks, and business decisions.
• Promote a collaborative culture focused on accountability, trust, problem solving, and customer success
• Build and develop a high-performing MSAT organization with strong technical expertise, leadership capability, and customer-focused mindset.
• Define organizational capabilities, workforce strategies, and succession plans to support current operations and future business growth.
• Mentor and coach technical leaders and team members, fostering innovation, scientific excellence, ownership, and continuous learning.
• Regular and reliable attendance on a full-time basis. • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
• Other duties as assigned.
Leadership Responsibility
• Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
• Identifies, recruits, and retains top-notch talent. • Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
• Develop employees to meet both their career and organizational goals.
• Builds strong customer relationships and delivers customer-centric solutions.
• Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
• Comfortable working in ambiguous situations and adaptable to change.
• Must model the highest degree of moral and ethical behavior and maintain confidential information.
• High degree of autonomy and strong decision-making skills.
Knowledge, Skills & Ability
• 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. Must have experience with commercial programs.
• Proficiency in risk management tools such as FMEA, root cause analysis, CAPA, and change control systems.
• Strong analytical capability with experience in statistical trending, data visualization, and process monitoring tools.
• Ability to lead complex cross-functional programs in a fast-paced client-service environment.
• Strong business acumen with understanding of CDMO operations, client contracts, timelines, and deliverables.
• Excellent verbal, written, and presentation skills with ability to communicate effectively with clients and executive leadership.
• Proven negotiation, influencing, and conflict-resolution skills. • Ability to prioritize multiple programs while maintaining high quality and execution standards.
• Strong leadership capability in coaching, developing, and retaining high-performing technical teams.
Education & Experience
• Master's or PhD degree in Engineering, Biotechnology, Life Sciences, or related discipline
• Minimum 10 years' experience with 5+ year's relevant experience in the cell and gene related field.
• Experience in working in a GMP environment is required
• Significant biopharmaceutical manufacturing/MSAT experience with increasing leadership responsibility, preferably in a CDMO environment.
• Strong knowledge of tech transfer, validation (PPQ), CPV, GMP operations, and regulatory expectations.
• Proven experience delivering client programs and supporting commercial manufacturing expansion.
• Demonstrated leadership in investigations, process troubleshooting, and cross-functional collaboration.
• Strong client-facing presence with experience managing external partnerships.
Quality Requirements
• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.
Working Environment
Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.
Physical Requirements
The physical and mental demands described below are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. While performing the duties of this role, the employee is required to:
• Ability to sit for extended periods (4-6 hours with breaks)
• Flexibility to reach, bend, and lift light materials (typically under 20 lbs) • Adequate vision to read documents and screens (correctable acceptable)
• Ability to hear verbal communication and phone conversations (accommodations considered)
• Tolerance for fluorescent lighting, climate-controlled spaces
• Dexterity for typing and using a computer equipment
• Ability to write, handle papers, and use office equipment
• Coordination for keyboard navigation
This role supports biopharmaceutical manufacturing and laboratory testing facilities. Employee may be asked to occasionally enter spaces which contain biological, chemical, or other hazards and are expected to comply with safety training, procedures, and PPE requirements associated with these areas.
This role may allow remote work, which includes the Physical Requirements above and the expectation to arrange a work environment that promotes the health and safety of the employee.
Frequency Definitions:
• Occasionally - up to 1/3 of the workday
• Frequently - 1/3 to 2/3 of the workday
• Constantly - 2/3 or more of the workday
Special Working Conditions
• This position may be required to travel up to 25%, which may include local and occasional overnight travel based on business needs.
• May be required to work Holidays and weekends and assist in shift work
Disclaimer The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.
