Supervisor, Manufacturing

Location
Cambridge, MA, United States
Posted
Feb 04, 2021
Ref
817
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

Position Summary:

The Supervisor, Manufacturing is responsible for oversight of manufacturing activities for cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:
  • Master all Team Lead, Manufacturing core responsibilities.
  • Assist in selection, development, and motivation of qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
  • Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Work with team and training leads to develop work plans, assign tasks, and supervise team(s).


Additional Responsibilities:
  • Supervise staff in the Manufacturing environment.
  • Generate the daily manufacturing schedule and master day sheet.
  • Actively perform and oversee daily cell culture activities to assure compliance with all company and regulatory procedures.
  • Conduct annual performance reviews and provide regular feedback based on goals.
  • Organize the staff and workload to meet or exceed productivity performance standards.
  • Complete corrective action plans to address deficient areas identified and to ensure adherence to compliance.
  • Be available on-call.
  • Serve as manufacturing SME for audit activities (internal & external)


QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.


Basic Qualifications:
  • Bachelor's degree or equivalent and 4+ years of working in GMP environment in the biotech or pharma industry
  • Must possess solid working knowledge of MS Office.
  • Fully trained with manufacturing of one cell therapy product.

Preferred Qualifications:
  • Previous supervisory experience.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Excellent communication skills, written and verbal.

WORKING CONDITIONS AND PHYSICAL DEMANDS
  • May be required to sit for long periods of time while performing cell culture operations.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Schedule is Sunday - Thursday, 1st shift
  • Rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas.