Associate Manager, Manufacturing Operations

Minaris Advanced Therapies•Allendale, NJ

1d•Onsite

About The Position

Minaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing, dedicated to turning breakthrough science into life-changing treatments. With over 1,000 experts across North America, Europe, and Asia, the company fosters a purpose-driven community focused on innovation, collaboration, and patient impact. The Associate Manager, Manufacturing is responsible for overseeing cGMP Operations, supervising manufacturing staff, and performing hands-on operational activities as needed. This role ensures that production adheres to full cGMP compliance through on-the-floor observation, direction, and participation.

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 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
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.

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.
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 Manufacturing Associates I, II, III, and Lead.