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Technical (Operations) Scientist

Your Role

Perform analysis of testing performed for a specific lab within Biologics.  

The Scientist will perform/ oversee a wide variety of safety testing required to manufacture clinical and commercial products. The Scientist will provide technical support to Molecular Operations lab within Biologics.  The Scientist is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations. 

  • Provides day to day technical support to the laboratory.
  • Performs analysis and interpretation of data in timely fashion.
  • Maintains high level knowledge of lab procedures and assays and is regarded as a subject matter expert (SME)
  • May serve as study director and ensures timely initiation and completion of all studies.
  • Prepares/ reviews protocols and final reports.
  • Ensures testing is performed in accordance with SOPs and regulations (cGMP and GLP) for custom/non-routine and new services.
  • Responsible for resolving deviations/ completing event investigations.
  • Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
  • Responsible for creating revising SOPs, laboratory records and other related documentation.
  • Provide technical advice and support for internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences.
  • Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.
  • Promote a culture of continuous improvement within Biologics; act as champion on initiatives and/or projects to drive improvement in quality and / or client service.
  • Performs other duties as assigned.

 

Who You Are

Minimum Qualifications:

  • Ph.D. in a scientific discipline (biology, chemistry, etc.) with 2 + years of working experience in laboratory setting -OR- Master’s degree in a scientific discipline (biology, chemistry, etc.) with 4+ years of working experience in a laboratory setting -OR- Bachelor’s degree in a scientific discipline (biology, chemistry, etc.) with 6+ years of working experience in a laboratory setting

 

Preferred Qualifications:

 

  • Relevant working knowledge and experience in the area of executing and overseeing technical projects and/or related studies in Molecular Biology, specifically utilizing QPCR, ddPCR and Sanger sequencing. 
  • Experience with laboratory automation is preferred.
  • Previous experience working in GMP/GLP environment is preferred.
  • Highly technically competent and is considered a scientific leader in a particular scientific area
  • 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
  • Intermediate skills in applicable computer programs

  RSREMD

RSREMD

Job Requisition ID:  190660
Location:  Rockville
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Chemistry, Scientist, Laboratory, QA, Science, Research, Quality

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