Philogen S.p.A. is accepting applications for the position of Plant Manager. The Plant Manager may also serve as Qualified Person.
Plant Manager reports directly to Philogen’s CEO and directs and manages all plant operations.
The Plant Manager is responsible for the day to day operations of a sterile products manufacturing facility. The role provides daily leadership to the fulfillment of GMP development and production activities as well as other support functions in compliance with applicable GMP regulations.
The Plant Manager also works collaboratively with other Business Units to scope, plan, and execute new business opportunities.
In particular, the successful candidate will take care of:
- Directing and managing plant operations for Production, Maintenance and Quality in the development, scale-up and technology transfer of products, including the production of cGMP products for clinical testing.
- Coordinating plant activities through the planning with departmental managers to insure the total manufacturing objectives are accomplished in a timely and cost-effective manner.
- Establishing and monitoring overall plant performances for production and quality standards according to good laboratory practices (GLP) and current good manufacturing practices (cGMP) guidelines.
- Providing leadership and training to accomplish the company goals and objectives.
- Implementing and maintaining preventative maintenance programs.
- Providing direction, development and leadership to the Production Manager.
- Planning the set up and qualification of a new Plant
Candidates should have the following profile:
- Proven experience in the management of a GMP plant
- Proven experience with inspections by the Competent Authorities for relevant authorizations of the production and release of drugs.
- Proven experience in the GMP production of proteins or biologics.
- BS/MS/PhD in Pharmaceutical Chemistry, Pharmacy, Chemistry, Biology, Medicine or Veterinarian Medicine.
- At least one year of experience in the Quality Control unit of a plant authorized to the production of medicinal substances.
- Excellent scientific writing skills and fluency of the English language.
- Previous appointment as Qualified Person of a plant authorized to the production of medicinal substances is preferred but not mandatory.