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Scientist 1 - Study Director

3 months ago

Rockville, United States Merck KGaA, Darmstadt, Germany Full time

 

Work Location:  Rockville, Maryland
Shift:  
Department:  LS-LS-TGMKD4 Team 4
Recruiter:  Genie Hooper


This information is for internals only. Please do not share outside of the organization.

 


As a Scientist 1 – Study Director,  with emphasis on molecular assays,  your activities will support safety testing required to manufacture clinical and commercial products. Acting as a Study Director, you will be responsible for GLP study design and oversight and scientific integrity of the technical work conducted and associated documentation, data interpretation, and reporting of study results. Requirements also include maintaining a thorough understanding of company testing services, technical principles and applications as they apply to your position. 

  • Hours:  12:00 - 8:00 pm (2nd shift pay differential)
  • Designs studies and oversees testing in accordance with SOPs and GLP regulations
  • Acts as subject matter expert (SME) and maintains a working knowledge of viral clearance procedures and assays
  • Maintains complete and comprehensive records for study integrity and performs data analysis
  • Utilizes problem solving/trouble shooting skills in real-time
  • Utilizes applicable computer programs during routine administration of tasks (i.e. Word, Excel, LIMS, TrackWise, etc.)
  • Liaise with Quality Assurance, Project Management, and appropriate cross-functional departmental areas to investigate deviations, communicate study progress, and relay preliminary results to clients
  • Creates/revises SOPs, laboratory records and other related documentation, as assigned
  • Performs training of laboratory personnel as needed/assigned
  • Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment
  • Acts as key driver/ champion on project teams
  • Complies with company health and safety regulations and procedures
  • Performs other duties as assigned 

 

Who you are:

 

Minimum Qualifications:

  • Ph.D. in a scientific discipline (e.g.,  Biology, Chemistry or Microbiology, etc) with 1+ years’ laboratory experience   -OR-
  • Master’s Degree in a scientific discipline (e.g.,  Biology, Chemistry or Microbiology, etc)  with 3+ years’ laboratory experience -OR-
  • Bachelor’s Degree in a scientific discipline (e.g.,  Biology, Chemistry or Microbiology, etc)  with 5+ years’ laboratory experienceâââââââ

 Preferred Qualifications:

  • Intermediate skills in Microsoft Office (Word, Excel, PowerPoint and Outlook)
  • Experience in GLP or GMP environment
  • Excellent oral and written communication and  time management skills
  • Highly collaborative, but able to work independently
  • Demonstrates a high level of initiative and leadership capabilities
  • Effective coaching and training skills for complex and highly technical work

 

 


 

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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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