Position Summary

About Minaris Advanced Therapies

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

Position Summary

Responsible for directing all facilities functions to ensure operational business units are supplied with necessary physical property to meet company objectives including facility maintenance, engineering and metrology. Specific responsibilities include preventative maintenance of facilities/systems, monitoring and calibration, managing engineering change control, troubleshooting equipment/processes, maintaining up-to-date as-built engineering drawings and Validation Master Plan, managing external contractors, writing reports and staffing and supervising a Facilities group competent in current Good Manufacturing Practices (cGMP) and cleanroom behavior. Interacts with internal departments as well as with material/equipment vendors and commercial partners. Assessing facility fit of incoming programs. Establish a shift structure to support multishift operations.

Responsible for providing Metrology services during start-up, commissioning, validation and capital improvements of existing and start of the art, multi-product contract manufacturing and testing facilities and their operations.

Remains current regarding technical engineering design requirements. Develops and/or modifies facilities/equipment/systems to be in a compliant state. Prepares test plans/methods, validation protocols, Standard Operating Procedures (SOPs), material specifications and investigations reports. Ensures group compliance with appropriate regulatory and/or engineering standards including but not limited to the Code of Federal Regulations (21CFR), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and/or Federal, State, Local EHS regulations and building codes. Maintain compliance with all procedures, policies, and regulations and ensure timely response to regulatory issues and inspection findings. May also be responsible for facilities security and/or act as liaison to leasing and property management organizations and planning commissions.

Essential Functions And Responsibilities

• Responsible for the direction of Facilities and Metrology services.
• Develop budget projections, material and staffing forecasts.
• Develop SOP’s, Test Reports, Out of Tolerance Notifications and Validation Protocols.
• Develops calibration schedules to meet customer and business goals.
• Provides accurate preventative maintenance forecasting methods with continuous improvement
• Implements and maintains personnel policies, procedures and production control systems.
• Ensure that all facility equipment is properly maintained, calibrated, qualified and /or validated.
• Evaluates new production procedures and technologies.
• Conducts failure analysis, root cause determination and corrective action determination.
• Updates “as-built” drawings as required.
• Directs utilization of equipment, facilities, and personnel to obtain maximum efficiency and meet organizational objectives.
• Examine equipment, processes, operations and organizational structure to determine time or quality revisions and suggest improvements.
• Directs capital improvement projects.
• Plan facility’s organizational structure to accommodate growth and change in priorities for site master plan.
• Generates high quality Maintenance, Engineering and Metrology summaries.
• Develop training requirements for staff and ensure training is effective.
• Communicate with Supervisor and other colleagues re: routine and exceptional events.
• Direct or lead investigations regarding deviations, out of tolerance condition, and unexpected results.
• Manage contractors for construction, renovation, validation, etc. as required.
• Contacts suppliers and vendors as required.
• Participates with other senior managers to establish strategic plans and objectives
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards.
• Flexible for weekends or nights if needed in the case of emergency or outside contractor working nights.
• Performs other duties as required.

Knowledge, Skills & Ability

• Demonstrated experience in team managerial skills.
• Having a strong working knowledge of the regulatory compliance requirements for the production of biologicals used in clinical studies or commercial manufacturing are essential.
• Demonstrates a clear understanding of the contract manufacturing business and effectively manages facility’s operations to address compliance, customer and business needs in a timely manner.
• Has a high degree of mechanical aptitude.
• Has excellent communication skills both verbal and written.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
• Demonstrated leadership skills.
• Ability to work effectively as part of a team.
• Ability to use judgment as dictated by complexity of situation.
• Ability to evaluate technical data and write technical documents.
• Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
• Ability to record data accurately and legibly.

Education & Experience

• Bachelor’s degree in a technical discipline (Mechanical, electrical or chemical engineering) with a Bachelor’s degree in a technical discipline (Mechanical, electrical or chemical engineering) with a minimum of 10 years experience in an Engineering capacity and a minimum of 5 years supervisory experience in a related technical field or equivalent training and/or experience.
• Must have a minimum of 5 years experience in a cGMP, Life Science Company.

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.

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.

Physical Requirements

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 10 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 10 lbs routinely/ often / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions

Working Environment

Employee will work with moderate noise levels. 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.

Special Working Conditions

• May be required to work Holidays, weekends and work Overtime
• May be required to work outside of normal business hours

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.

Benefits

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.