Job Description

Associate Manager, Manufacturing Operations 

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together.  We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.  We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. 

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

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 HCATS 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 work flow, 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 MSAT to cGMP Manufacturing Operations.

Utilize Operational Excellence Principles to identify and reduce areas of risk in company processes.

Perform cGMP 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.

Qualifications

Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering) or relevant experience.

2 - 5 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience.

2 - 3 years of leadership experience or equivalent combination of experience.

Competencies/Candidate Profile

Relevant IT skills (able to work with Visio, Microsoft Project 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

Supervisory Responsibility

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

Minimum Required Training

GMP Training

Manager Training

Working Environment

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.  Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  

While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is regularly required to climb or balance; stoop, kneel, or crouch. The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance).

Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) 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.

Direct reports

Manufacturing Associate I

Manufacturing Associate II

Manufacturing Associate III

Manufacturing Lead

Other Duties

Please note 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.