Lab Manager - QC Analytical Development, GMP

PPD   •  

Middleton, WI

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 29 days ago

The basic purpose is to ensure efficient and effective management of PPD resources. The objective is to supervise and assist group leaders and scientists in laboratory operations for the Extractable/Leachable (E/L) department of PPD, with tasks such as scheduling, resource management, technical and compliance related issues. To plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. This position assists the division director in strategic planning, business development and expansion initiatives by providing mid range (1-3 month) resource utilization predictions for a department. Proven leadership experience from other positions at major pharmaceutical industry companies is considered a plus.

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Qualifications

Education and Experience:

  • B.S. in Chemistry or related science plus 10 or more years’ experience in a pharmaceutical or biotech laboratory, preferably including experience in conducting or overseeing E/L studies OR
  • M.S. in Chemistry or related science plus 8 or more years’ experience in a pharmaceutical or biotech laboratory, preferably including experience in conducting or overseeing E/L studies OR
  • Ph.D. in Chemistry or related science plus at least 6 years’ experience in a pharmaceutical or biotech laboratory, preferably including experience in conducting or overseeing E/L studies
  • Minimum 5 years management experience in the pharmaceutical, biotech or analytical contract laboratory industries. Management experience should include stability/QC/analytical R&D/ project and program management, direct supervision of technical staff, and direction of laboratory operations and implementation of process and system improvements
  • Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

Knowledge, Skills and Abilities:

  • Full understanding of cGMP requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
  • Full understanding and knowledge of separation science and general chemistry, preferably including extractable/leachable, trace level analysis, analytical method development/validation and stability testing experience
  • Proven technical troubleshooting and problem solving abilities
  • Effective technical writing skills
  • Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment
  • Ability to implement quality systems and process improvements
  • Ability to provide guidance to clients on analytical issues and regulatory requirements
  • Biopharmaceutical as well as small molecule analytical experience is considered a plus
  • Experience or familiarity with toxicological safety data review is considered a plus
  • Strong understanding of chromatography (GC and HPLC) and the use of mass spectrometry for structural elucidation is considered a plus
  • Understanding of budgeting, revenue projections and other financial terms and definitions at it applies to the business
  • Supervisory skills in resource allocation, hiring and recruiting and other related functions
  • Leadership skills especially interpersonal and communication skills
  • Proven ability to cope with a dynamic work environment

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