Manager, CML Laboratory

Recruiter
Pfizer
Location
Sandwich
Posted
12 Oct 2016
Closes
25 Oct 2016
Contract Type
Permanent
Company description: About Pfizer A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Job description: This position will be responsible for the management of a small team of scientists and staff supporting the Pfizer Global Security anti-counterfeiting operation. The successful candidate will be responsible for personnel management (e.g. work assignment, oversight, development, performance management), management of the laboratory operation and hands-on laboratory support for evaluation of Global Security and PCom samples. As a member of the Scientific and Laboratory Services - Analytical Sciences (SLS-AS) team, the incumbent will be responsible for independently understanding and performing forensic analytical testing of pharmaceutical and consumer health care products and evaluating and documenting the results in a timely manner. The primary purposes of this role are to provide management support for the laboratory personnel and support for Pfizer Global Security's forensic activities in the EMEA and APAC Regions. Laboratory support includes anti-counterfeit testing, forensic method development/ method validation / method transfer; special testing in support of customer complaints, unknown chromatographic peak identifications, and enforcement/ regulatory agency support. Non-laboratory technical support includes review of scientific content for enforcement/ regulatory responses, trial preparation; trial testimony; case development activities, and support of Pfizer Global Security initiatives. The successful candidate will be expectated to develop and maintain a full understanding and independent implementation of required standards (i.e. EHS (environmental health and safety), cGMPs (current Good Manufacturing Pratices) (as required); departmental SOPs and written test procedures in daily work. The candidate will be capable of performing testing and management functions within expected time frames, and maintaining quality and productivity at acceptable levels as communicated by the Sr. Manager. Keeps Sr. Manager informed of project status and communicates critical information in a timely manner. Exhibits ability to multi-task. Performs additional duties as necessary to maintain the local team and SLS-AS operations (e.g. prepares SOPs, actively participates in SLS-AS laboratory teams). Assures the maintenance of clean and organized work and archive areas and assures that acceptable practices are used in the laboratory. Troubleshoots and maintains laboratory instrumentation in good working condition and provides guidance and leadership to more team members in this function. Position requires ability to travel (estimated 5% - 20%) in order to provide support the Global Security, legal depositions or testimony at trials. Responsibilities Manages the Sandwich SLS-AS anti-counterfeit laboratory team. Develop Scientists and maintain a collaborative team environment. Performs forensic examination and analytical testing of pharmaceutical and consumer health care products, e.g. anti-counterfeit testing and customer complaint testing. Interacts with Global Security customers to assure timely and prioritized response to sample evaluation requests. Demonstrates strong theoretical and working knowledge of chromatographic and spectroscopic laboratory techniques (e.g. FT-IR, UV-VIS, microscopy, PXRD, HPLC, HPLC-MS, and GC). Demonstrates strong working knowledge of chromatographic data acquisition systems (e.g. Empower) and lab computerized systems. Posseses and maintains comprehensive knowledge of regulations including, but not limited, to, ICH guidance, cGMP, EHS, MHRA /controlled substances. Demonstrates excellent oral and written communication skills. Works both independently and as part of the SLS-AS and Global Security teams. Conducts non-laboratory technical support including review of scientific content for enforcement/ regulatory responses, trial preparation; trial testimony; case development activities; and support of Pfizer Global Security initiatives. Performs forensic method development/ method validation/ method transfer; and additional special testing (e.g. unknown chromatographic peak identifications related to forensic samples). Independently and proactively applies knowledge to equipment and method troubleshooting/investigations. Ability to multi-task and adapt to changes in priorities/work assignments to meet overall team objectives and customer requirements This position will interact with the Senior Manager, SLS-AS, located in Kalamazoo, Michigan, USA; SLS peers and Team Leaders; and Pfizer Global Security colleagues. This position will require interaction with external regulatory and law enforcement agencies. Interactions with lawyers may be required, at depositions or at testimony at trials. Financial Accountability: Laboratory equipment and supplies purchasing. Team travel. Supervision: Group including 2 scientists and one administrative support staff. Qualifications and Skills Ph.D. degree in Chemistry or related field with pharmaceutical experience M.S. degree in Chemistry or related field with pharmaceutical experience B.S. degree in Chemistry or related field with pharmaceutical experience Demonstrated leadership skills required. Management experience preferred. Experience with analytical testing of pharmaceutical and consumer health care products required. Experience with anti-counterfeit testing and customer complaint testing preferred. Strong theoretical and working knowledge of chromatographic and spectroscopic laboratory techniques (e.g. FT-IR, UV-VIS, microscopy, PXRD, HPLC, HPLC-MS, GC) required. Strong working knowledge of Chromatography Data Systems and lab computerized systems required, Empower experience preferred. Comprehensive knowledge of regulations including but not limited to ICH guidance, cGMP, EHS, MHRA /controlled substances. Excellent oral and written communication skills required. Experience with forensic and analytical method development/ method validation/ method transfer; and special testing, preferred. Experience with non-laboratory technical support for enforcement/ regulatory activities, preferred. Experience with analytical equipment and method troubleshooting/investigations. To apply please visit www.pfizercareers.com and search for Job ID: 1038871. Required profile: Ph.D. degree in Chemistry or related field with pharmaceutical experience M.S. degree in Chemistry or related field with pharmaceutical experience B.S. degree in Chemistry or related field with pharmaceutical experience. What we offer: Competitive salary and benefits. This job was originally posted as www.totaljobs.com/job/66871630