Manager, IQ/OQ/PQ Instrument Support

🔍 Middleton, Wisconsin, United States

📁: Labs

📅   : Jun 12, 2019 Post Date

📅   : 562 Total Views

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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 Analytical / QC and Metrology 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 Quality science and general chemistry, preferably including analytical Instrument troubleshooting and calibration and maintenance.
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 systems is 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

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.