Cell Therapy Production Supervisor

Employer
MaSTherCell
Location
Webster, Texas (Houston Metropolitan Area)
Salary
$74,880 - $87,360
Posted
Jun 25, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

MaSTherCell is a dynamic Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

 

RESPONSIBILITIES

The Cell Therapy Production Supervisor is responsible for global management of one (1) or several specific projects to be transferred in the Production Department and production of the first series of clinical batches, followed by transfer of the project to a Production Supervisor.

Phase I

  • Once contract is concluded with the client, responsible for early phases of technology transfer from client to Masthercell which entails meetings with client, set up of quality with Front End colleagues, and observation of production at the customer’s premises.

    Phase II

  • Build dedicated team. Review appropriateness of dedicated staff training matrix and adapt according to needs (including technology and environmental health and safety (EHS)).
  • Fine tune timing (process/budget/resources).
  • Evaluate equipment needs, user requirement specification (URS), supplier selection, ordering, Factory Acceptance Testing (FAT), reception, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in collaboration with Shared Service Supervisor.
  • Select raw materials and disposable supplier (Raw materials/Consumables (RM/CP/CC)).
  • Set of bill of material (BOM).
  • Identify establishment for raw material, disposable and starting material.
  • Implement the project on Masthercell’s premises.
  • Execute lab tech transfer/reproducibility runs.
  • Establish all documentation and qualification/validation protocols/runs/reports specific to the project for process and equipment (Specific Master Batch Record (MBR) and Aseptic Process Simulation (APS) included).
  • Manage according to change control and risk assessment.

    Phase III

  • Finalize all specific Good Manufacturing Practice (GMP) documentation.
  • Run and release of first clinical batches and apply all GMP requirements.
  • Transition project to the Production Supervisor.
  • Prepare reports for client and internal.

 

SKILLS/QUALIFICATIONS

  • Efficient Communicator.
  • Sense of Ethics.
  • Demonstrated Leadership.
  • Cross Functional Team Spirit.
  • Project Driving Management
  • Technical Expertise.
  • Quality Minded.
  • Rigorous.
  • Customer Oriented.

 

EDUCATION/EXPERIENCE

  • Master’s Degree in Biology, Chemistry, Bioengineering, Pharmacy or relevant experience in the fields of Biotech/Pharma/Cell therapy.
  • Minimum of five (5) years’ experience in GMP, cell culture production and/or human cells cultivation.

 

PLEASE BE SURE TO INCLUDE YOUR SALARY REQUIREMENTS!

NO TELEPHONE CALLS PLEASE!