Manager, Raw Materials

Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing! With state-of-the-art facilities across three continents and a team of over 1,400 industry experts, we are pioneering the future of advanced therapies. Our team has a proven track record of delivering more than 7,500 GMP batches, manufacturing two commercial cell therapies, and providing testing services for over 27 commercial products. At Minaris, you will be part of a mission-driven organization dedicated to accelerating life-saving treatments, advancing cutting-edge technologies, and transforming patient outcomes worldwide. Be a part of a company built for speed, scale, and science – where your expertise will help shape the future of healthcare.

This position will be responsible for management of the Raw Material inspection program at the Minaris Allendale facilities. This includes building an appropriate organization structure to maintain a raw materials inspection process per the applicable regulations. Routine activities include creation and revision of raw material inspection procedures and forms, document and data reviews and approvals. Collaborate with other departments to support organizational and functional strategy. Represents Raw Materials inspection program in internal and external audits which may include interaction with regulatory health authorities and clients.

Essential Functions And Responsibilities

• Hire, manage and develop team members within the Quality Raw Material group.
• Provide oversight of incoming raw materials and components inspection are in accordance with established SOPs and specifications.
• Determine and communicate inspection, sampling, and release priorities, and distribute work assignments to staff.
• Serves as the SME to resolve any issues related to raw material or component disposition.
• Understands and makes informed decisions pertaining to Raw Material disposition.
• Collaborate with project teams and assist in defining qualification plan for raw materials.
• Provide quality oversight in Material Review Board committee.
• Develop and generate Raw Material KPI to support quality review.
• Assure any significant Quality issues are communicated to key stakeholders in a timely manner.
• Support agency, internal and/or client audits.
• Ensures adequate training (skills-based, cGMP and Safety) of Quality Raw Material team members to assure that they are qualified to perform their specific job responsibilities.
• Keeps up to date with compliance and regulation guidelines within the industry
• Ensures all testing processes, monitoring and departmental documentation meet cGMP regulatory standards.
• Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
• Recommends process improvements to achieve greater efficiency within the department and between sites.
• Participate in department and cross functional meetings.
• 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

• Enhanced attention to detail to accomplish error-free activities.
• Analytical and problem-solving skills
• Flexible and able to adapt to company growth and evolving responsibilities.
• Ability to work independently and with cross functional teams.
• Highly organized and detail oriented
• Effective communication skills, written and verbal and the ability to partner and collaborate with partners from various functions.
• Able to prioritize and multi-task in a dynamic fast paced environment with the ability to react quickly to changing priorities
  
  

Education & Experience

• Minimum 1-2 years of people management experience
• 5 years Experienced in “Incoming Materials Inspection.”
• 5 years Experienced in “Incoming Materials Inspection.”
• B.S in biological sciences or other relevant fields of study or equivalent experience in commercial raw materials management.
• 10 years’ experience working within a GMP regulated industry, cell therapy is plus.
• Experience in authoring, reviewing, and/or approving cGMP documents.
• Compliance Experience
• Experienced in “Continuous Process Improvement”
• Knowledge of Analytical and Microbiology Lab activities
• Experience with documentation control
• Familiar with FDA, ISO, and other regulatory agency guidelines.
• Ability to make independent decisions based off industry and regulations knowledge.
• Experience in on-boarding new raw materials.
• Experience in both clinical and commercial manufacturing is preferred
• Relevant computer skills (Microsoft Office, Outlook, ERP and EDS)
• Strong understanding of 21 CFR 210, 211 FDA cGMP) and other relevant ICH regulations and guidance
• Strong understanding and implementation of “Good Documentation Processes
  
  

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

Constantly 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 it is used to represent up to 1/3 of the time given to the workday; frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Special Working Conditions

Must be able to work occasional weekends, nights, and/or holidays as required/necessary.

May be exposed to infectious diseases transmitted through human blood

This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space.

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.