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Supervisor, Product Characterization

Employer
Millipore Corporation
Location
Rockville, MD
Closing date
Oct 22, 2020

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Industry
Science
Function
Management
Hours
Full Time
Career Level
Experienced (Non-Manager)
Your role:Supervise associate scientists and/or lab technicians in a laboratory within Product Characterization Lab. The Lab Supervisor will oversee Analytical and Immunoassay assays required to characterize product or material safety in addition to supervision of all Associate Scientists and/or lab technicians in the lab with a focus on assay transfer, development and validation. Tasks include oversight and overall management of the lab and responsibility for lab metrics. The lab supervisor will also make scientific observations, maintain detailed documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining an understanding of BioReliance services, technical principles and applications.Responsible for compliance of studies under the principles of GxP.May act as Study Director/Management with responsibility for the scientific conduct of GLP or GMP studies. Document scientific observations and coordinate all activities associated with day to day laboratory operations.Schedule the conduct of assays by lab staff and coordinate other activities associated with assay transfers such as batch record/SOP/Validation protocol/tech spec review, generation and revisionEnsure the necessary paperwork is received to facilitate on time lab initiation and assay launch of new service offerings.Review study data for accuracy, adherence to compliance and completeness of documentation.Conduct thorough scientific investigations to determine the root cause for each deviation and nonconformance. Document all aspects of the investigation in a timely manner. Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.Stay current with SOPs and regulations (cGMP and GLP). Periodically evaluate laboratory procedures, system controls and technical documentation such as SOPs and batch records to ensure compliance.Manage the use and maintenance of scientific equipment and instrumentation, computer systems; Ensure that they are kept in a calibrated / validated state and part 11 compliant.Assist in site visits (Technical and QA), complete client requests and addressing site visit/ audit findings in a timely manner.Participate in conference calls and anticipate/ address client questions as appropriate. Provide direct supervision to Associate Scientists and/or Laboratory Assistants. Meet with direct reports to set goals, conduct regular one-on-one discussions with employees, ensure development plans are in place for all employees, address personnel issues promptly, interview and hire new candidates and complete performance reviews fairly and on-time.Act as point of contact for departmental training, ensuring training modules are created and up to date.Participate in division-wide initiatives including Quality systems improvements, trans-divisional SOPs revisions, Lean projects, etc.Perform other duties and responsibilities as appropriate or required. Who you are:Minimum Qualifications:Master's degree in a scientific discipline (ie Chemistry, Biochemistry, etc.) with 3+ years of relevant laboratory experience - OR - Bachelor's degree in a scientific discipline (ie Chemistry, Biochemistry, etc.) with 5+ years relevant laboratory experience - OR - Associate degree in a scientific discipline (ie Chemistry, Biochemistry, etc.) with 7+ years relevant laboratory experience 2+ years' experience leading and/or supervising staff in a laboratory settingPreferred Qualifications:Experience in Analytical Chemistry Experience validating assays to meet ICH, FDA and/or EMEA guidelinesIntermediate skills in applicable computer programsExcellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.Excellent time management skillsHighly collaborative as well as independentDemonstrates a high level of initiative and leadership capabilitiesEffective supervisory, coaching and training skills for complex and highly technical workHighly, technically competentRSRMS

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