MSAT - Director Manufacturing Sciences and Technology

Minaris Advanced Therapies•Allendale, NJ

About The Position

The Director of Manufacturing Sciences and Technology (MSAT) provides strategic and technical leadership for clinical and commercial manufacturing support, client program execution, technology transfer, process performance, process validation readiness, product lifecycle management, and continuous improvement. The role translates scientific knowledge into practical manufacturing strategies and risk-based decisions, supporting successful client delivery, robust processes, commercial performance, and organizational growth. The Director works closely with clients and teams across Business Development, Commercial, Process Development, Analytical Development, Manufacturing, Quality, Regulatory, Finance, Engineering, Supply Chain, and IT. The position leads MSAT strategy and technical input for new business opportunities; oversees technology transfer and CMC strategies; supports process characterization, validation, commercial launch, and sustained supply; and drives data-informed process monitoring and operational excellence. The role also builds and develops the MSAT organization, including its capabilities, workforce strategy, succession planning, and employee development. The position requires compliance with applicable quality, safety, regulatory, and company requirements. It may allow remote work, requires travel of up to 25%, and may involve off-shift, weekend, holiday, overtime, and shift-work duties. The employee may occasionally enter manufacturing or laboratory areas with biological, chemical, or other hazards and must follow applicable safety procedures and PPE requirements.

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 therapy-related field.
Experience working in a GMP environment.
Significant biopharmaceutical manufacturing or MSAT experience with increasing leadership responsibility.
Experience with commercial programs.
Deep knowledge of biopharmaceutical manufacturing processes; understanding of cell therapy, gene therapy, or advanced therapies is required or expected by the role.
Strong understanding of GMP regulations, ICH guidelines, FDA and EMA expectations, and validation lifecycle principles.
Expertise in technology transfer, comparability strategy, PPQ, CPV, and lifecycle process management.
Proficiency in risk management tools and practices, including FMEA, root cause analysis, CAPA, and change control systems.
Strong analytical capability, including 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, including the ability to communicate 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 experience delivering client programs and supporting commercial manufacturing expansion.
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 based on business needs.
Ability to use English written and oral communication skills for job duties.
Ability to comply with safety training, procedures, and PPE requirements when entering areas with biological, chemical, or other hazards.

Nice To Haves

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

Responsibilities

Provide strategic leadership and direction for the MSAT organization, aligning technical priorities with business strategy, client programs, and growth objectives.
Lead technical input and strategy development for new business opportunities, including proposals, RFP responses, due diligence, and technology assessment packages.
Partner with Business Development, Commercial, Process Development, Manufacturing, Quality, Regulatory, and Finance to develop competitive, executable proposals.
Assess technical feasibility, manufacturing readiness, capacity requirements, and process risks for prospective programs.
Represent MSAT in client presentations, technical discussions, governance meetings, steering committees, and strategic partnership engagements.
Build client relationships and translate client 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 client products, process changes, scale-up, and site-to-site transfers, ensuring effective knowledge transfer and manufacturing implementation.
Oversee Process Development and Analytical Development deliverables to ensure processes, methods, and control strategies are developed, characterized, documented, and ready for GMP manufacturing transfer.
Develop and execute CMC strategies for process characterization, optimization, comparability, validation, regulatory readiness, and product lifecycle management.
Lead PPQ, CPV, FMEA risk assessments, and process monitoring strategies to support robust, compliant, scalable manufacturing.
Use data science, AI-assisted predictive analytics, and digital tools to improve process understanding, identify risks, and enable proactive process control.
Lead commercial readiness, 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 transparent communication across MSAT, manufacturing sites, clients, and cross-functional organizations; translate technical information into clear strategies, risks, priorities, and business decisions.
Build partnerships across PADI, Manufacturing, Quality, Supply Chain, Engineering, and IT to enable program execution.
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 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, technical competency models, and training programs.
Identify, recruit, and retain talent; set performance standards; support employee engagement through delegation, feedback, goal setting, and performance management.
Develop employees to meet career and organizational goals and maintain transparent organizational communication.
Ensure compliance with laws, regulations, company policies, FDA and worldwide quality requirements, established procedures, training requirements, and data-integrity standards.
Maintain regular and reliable full-time attendance and professional behavior consistent with company policies and values.
Protect confidential information, model ethical conduct, exercise sound independent judgment, and adapt to ambiguous situations and change.
Perform other duties as assigned.