Associate Manager, Manufacturing Operations

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

The Associate Manager, Manufacturing is responsible for overseeing the cGMP Operations, supervising manufacturing staff, as well as performing hands-on operational activities when necessary. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.

Essential Functions and Responsibilities

• Regular and reliable attendance on a full-time basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflect 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.
• Efficiently and effectively make operational and manufacturing decisions that impact the quality of the product.
• Analyze and seek opportunities to improve capacity availability of resources, report out adherence to schedule metric.
• Track and drive personnel process proficiency
• Ensure CER’s are kept in a clean, validated state in compliance with Minaris procedures, GMP and applicable regulations.
• Ensure staff is in compliance with Corporate and site-specific HR, safety, and business policies and practices.
• Alert site EHS officer of any safety issues and partner with them to resolve.
• Lead shift handover to direct workflow, assess schedule adherence, provide status updates to the team and management.
• Maintain the process record (MBRs, work instructions, forms, logbooks, equipment status) accurate and complete.
• Identify and resolve technical, procedural, and equipment issues that hinder production and compliance. Communicate with team members, peer managers and members of other departments, as appropriate, to assure transparency in prompt resolution of problems.
• Assist in the transfer of technology from PD and CMC to cGMP Manufacturing Operations.
• Utilize Operational Excellence Principles to identify and reduce areas of risk in company processes.
• Perform cGMP, self-inspection, and safety walk-thru’s, document and follow through on corrective / preventative actions and provide assistance with periodic audits.
• Coordinate with other departments for raw materials, testing requirements, documentation, validation, maintenance, and scheduling.
• Own (generate, revise and implement) Standard Operating Procedures (SOPs), Batch Production Records (BPRs), work instructions and forms; review the flow of documentation against facility/equipment layout, implementing improvements as necessary.
• Execute improvement projects, drive continuous improvement activities to improve departmental efficiency, resource utilization and quality compliance.
• Design and deploy practices, processes, and procedures which allow the team to meet the expectations and requirements of internal and external customers.
• Partner with peer process owners: educate direct reports, provide necessary process inputs from his/her shift, and communicate process performance at extended shift huddle.
• Manage selection, training, performance, evaluation and development of staff.
• Support and report out metrics (KPIs, ROIs) for Business Process Management and Strategic Enterprise Evolution implementation.
• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervises the following roles:
• Manufacturing Associates I, II, III, and Lead

Knowledge, Skills & Ability

• Relevant IT skills (able to work with MS Word, PowerPoint,and Excel)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Meeting management/facilitation skills/teamwork
• Ability to multi-task team is essential
• Flexible and able to adapt to company growth and evolving responsibilities
• Drive to create and maintain order in a fluid technically complex environment
• Integrity, accountability and strong dedication to regulatory compliance
• Continuous improvement mindset

Education & Experience

• Bachelor's degree (eg Biology, Biotechnology, Bioengineering, Chemical Engineering) or relevant experience.
• 2 - 5 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience or similar.
• 2 - 3 years of leadership experience or equivalent combination of experience.

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

Onsite Employees: 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 and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties the employee is:

• Constantly required to sit, and to reach to use computers and other office equipment
• Frequently stand for extended periods of time, up to four hours/time
• Frequently required to lift up to 40 pounds
• Constantly required to view objects at close and distant ranges with hand and eye coordination
• Frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Special Working Conditions

• Must have the ability to work in a team-oriented environment and with clients
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, and photocopiers. Seating is mixed and includes open space seating, cubicle, and office space.
• Non-absorbent laboratory coats are required, as well as nitrile and sterile gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryogloves must be used when working with liquid nitrogen.
• Gowning proficiency as needed.

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.