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Scientist 1

Your role:

 

As a Scientist 1 your activities will support assay development through commercial application of new and innovative service offerings within the biosafety testing space. You are responsible for the scientific integrity of technical work performed in the laboratory, and are required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of company testing services, technical principles and applications as they apply to your position.

 

Perform assays/ testing to GMP compliance for a laboratory within Biologics.  This position may have Study Director responsibilities. For all assigned GLP studies, fulfills all aspects of the Study Director role as required by regulations.

 

The Scientist 1 will perform safety testing required to manufacture clinical and commercial products. The Scientist 1 is required to make scientific observations, maintain detailed workbooks/ documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of BioReliance services, technical principles and applications.  For GLP studies, perform all aspects of the role of Study Director with overall scientific responsibility for the study design, interpretation, and reporting of study results.  This is a second shift position.

 

Responsibilities will include but are not limited to:

  • Performs testing in accordance with SOPs and regulations (cGMP and GLP)
  • Act as subject matter expert (SME) for specific defined area(s) of BioReliance business.
  • Applies laboratory techniques and skills to complete experiments designed to address a variety of specific problems.
  • Independently applies basic scientific principles in the design of experiments and the development of assays.
  • For GLP studies, acts as Study Director.
  • Maintains complete and comprehensive records for study integrity.
  • Makes detailed observations, documents results and performs data analysis.
  • Operates and maintains lab equipment as required by SOPs and testing procedures.
  • Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
  • Utilizes problem solving/ trouble shooting skills.
  • Communicates deviations/ events, progress and interim results to Study Management.
  • Leads the completion of event records.
  • Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
  • Maintains a working knowledge of lab procedures and assays.
  • Creates/ revises SOPs, laboratory records and other related documentation as assigned.
  • Writes technical reports for internal use and collaborates on papers for external use.
  • Performs training of laboratory personnel as needed/ assigned
  • Contribute 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.
  • Required to work 2nd shift.

 

Who You Are:

Minimum Qualifications:

  • Ph.D. in scientific discipline (i.e. Biology, Chemistry, etc.) with 1+ years relevant laboratory experience – OR – Master’s degree in scientific discipline (i.e. Biology, Chemistry, etc.) with 2+ years relevant laboratory experience – OR – Bachelor’s degree in scientific discipline (i.e. Biology, Chemistry, etc.) with 5+ years relevant laboratory experience

 

Preferred Qualifications:

  • Broad working knowledge of field and experience with relevant laboratory practices, techniques, equipment, materials and mathematical calculations
  • 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 coaching and training skills for complex and highly technical work
  • Highly, technically competent

 

RSRMS

Job Requisition ID:  202548
Location:  Rockville
Career Level:  C - Professional (1-3 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.


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