Laboratory Supervisor Analytical Services

Posted 08 Aug 2018

Rockville, Maryland - United States

Req Id 179703

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role

The Lab Supervisor will oversee a wide variety of assays or tests required to characterize product or material safety in addition to supervision of Associate Scientists and/or lab technicians in the lab. 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.

ESSENTIAL JOB FUNCTIONS

  • Responsible for compliance of studies under the principles of GxP.
  • Act as Study Director with responsibility for the scientific conduct of GLP studies.
  • Act as the study management / responsible person on the release of test results in a GMP study.
  • Document scientific observations and coordinate all activities associated with day to day laboratory operations.
  • Schedule the conduct of assays by lab staff and coordinate the scheduling samples to be tested. 
  • Ensure the necessary paperwork is received to facilitate on time lab initiation of studies.
  • 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 up to date and training matrix reflects staff capabilities.
  • 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

  • Education (minimum requirements):
    • MA/MS in scientific discipline with 2 or more years of relevant experience in managing/supervising teams
    • BA/BS in scientific discipline with 5 or more years relevant experience in managing/supervising teams
  • Experience:
    • Familiarity with High Complexity Analytical equipment used to characterize protein complexes such as monoclonal antibodies, fusion proteins, etc.
    • Relevant working knowledge and experience in Analytical Biochemistry, Product Stability and Biostorage
    • Experience leading and/or supervising staff in an Analytical Biochemistry laboratory setting
  • Knowledge and Skills:
    • Intermediate skills in applicable computer programs
    • Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
    • Excellent time management skills
    • Highly collaborative as well as independent
    • Demonstrates a high level of initiative and leadership capabilities
    • Effective supervisory, coaching and training skills for complex and highly technical work
    • Highly, technically competent

ADDITIONAL LOCAL NEEDS

  • 0-10% Travel required

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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