Associate Manager, Manufacturing Operations

Minaris • Allendale, NJ

1d • Onsite

About The Position

The Associate Manager, Manufacturing is responsible for overseeing the cGMP Operations, supervising manufacturing staff, and performing hands-on operational activities to ensure production is maintained in full cGMP compliance through on the floor observation, direction, and participation. This role requires regular and reliable full-time attendance, exhibiting professional behavior consistent with company policies and practices, and embodying Minaris Advanced Therapies values. The position involves efficiently and effectively making operational and manufacturing decisions that impact product quality. Leadership responsibilities include supporting a diverse and inclusive culture, ensuring compliance with laws and company policies, identifying and retaining talent, setting performance standards, encouraging employee engagement, and developing staff. The Associate Manager will build strong customer relationships, maintain transparent communication, and be adaptable to change, modeling high moral and ethical behavior while maintaining confidential information. Supervisory duties include interviewing, hiring, training, planning, assigning, directing work, appraising performance, rewarding, disciplining, addressing complaints, and resolving problems for Manufacturing Associates I, II, III, and Lead. The role also ensures compliance with all FDA and Worldwide Quality & Compliance regulations, adheres to established procedures and protocols, prioritizes continuous training, and upholds the highest standards of data integrity for accuracy, compliance, and operational excellence.

Requirements

• 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
• 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
• Bachelor's degree (e.g., 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

Responsibilities

• Overseeing the cGMP Operations
• Supervising manufacturing staff
• Performing hands-on operational activities when necessary
• Ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation
• 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
• Embodying Minaris Advanced Therapies values and aligning 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
• 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
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
• Interviewing, hiring, and training employees
• Planning, assigning, and directing work
• Appraising performance
• Rewarding and disciplining employees
• Addressing complaints and resolving problems
• 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
• Uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level