Open positions

Job Title: BIOCHEMICAL QUALITY CONTROL MANAGER
Location: Siena - Italy
Department:

Philogen S.p.A. would like to hire a Biochemical Quality Control Manager who will report directly to the Quality Control Manager.

In particular the successful candidate will be Responsible for:

  • Biochemical laboratory functions and the corresponding documentation to support the timely disposition of product.
  • Overall Quality control disposition of incoming materials, in process samples and finished products.
  • Analytical method set-up, validation, trasfer and writing reports.
  • Management of site products stability studies.
  • Reviewing and approval of the entire SOPs relating to Quality control tasks and ensuring understanding and implementation of these SOPs.
  • Insuring compliance of laboratory procedures and practices with Philogen Quality standards and with GMP and GLP regulations.
  • Support to the critical quality attributes identification and control strategy definition.
  • Supporting laboratory colleagues in all aspects of their work to achieve the completion of tests and/or investigations in a timely manner as well as maintaining an updated knowledge base in the technical, operations, company policy and regulatory fields.
  • Support day to day scheduling activities closely with the QC manager.
  • Facilitating continuous improvement in QC day to day operations and general systems and will actively support achievement of plant goals.Coaching and developing QC colleagues to achieving high performance.
  • Promote the technological innovation, scientific understanding and best practies, to design an integrated analytical development strategy, within the QC manager.
  • Assist with regulatory agency inspections as needed.

The ideal candidate should have:

  • A good scientific background.
  • People management experience.
  • Comprehensive knowledge of GMP.
  • Minimum 5 years’ experience in Biochemical Quality Control management in pharmaceutical industry field.
  • Knowledge of the following analytical techniques: E.L.I.S.A. immunoassays, SDS-PAGE Electrophoresis, Size Exclusion Chromatography/ Cation Exchange by HPLC, GC, chemical-physical analytical determinations, bioassay, cells proliferation assay, cell culture, real time PCR, raw materials analysis.
  • Knowledge of method validation and trasfer, in compliance with EP/USP.
  • Good in-depth knowledge of quality process control and statistical techniques.High analytical skills.
  • Communication & high interpersonal skills.
  • Problem solving skills.
  • Good planning and organization capabilities.
  • A high level of attention to detail and the ability to prioritize working tasks.
  • High level of initiative and focused on improvement.
  • Good English knowledge.

We offer:

  •  A dynamic environment.
  • A permanent contract with a salary proportional to the experience level of the successful candidate.

Job location:
Siena – Italy

 

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Open Position

careers search
department
location