Scientist 1 - Flow, Elisa & GMP - 2nd Shift

MerckRockville, MD
Onsite

About The Position

This role supports assay development through commercial application of new and innovative service offerings within the biosafety testing space. The Scientist 1 is responsible for the scientific integrity of technical work performed in the laboratory, making scientific observations, maintaining detailed workbooks/documentation, and ensuring all documentation fulfills generally accepted professional/industry standards. A thorough understanding of company testing services, technical principles, and applications as they apply to the position is required. The shift hours are Monday - Friday 11am - 7:30pm.

Requirements

  • Ph.D. in scientific discipline (Immunology, Chemistry, Biology, etc.) with 1+ years of experience in a laboratory environment
  • OR Master’s degree in scientific discipline (i.e., Immunology, Chemistry, Biology, etc.) with 3+ years of experience in a laboratory environment
  • OR Bachelor’s degree in scientific discipline (i.e., Immunology, Chemistry, Biology, etc.) with 5+ years of experience in a laboratory environment
  • External applicants must be eligible to work in the US.
  • This role does not offer sponsorship for work authorization.

Nice To Haves

  • PhD in Immunology
  • Extensive hands-on experience with Flow Cytometry/cell sorting techniques (potency, titer, viability or identity)
  • Hands-on experience with Mammalian cell-based Immunoassays (preferred cell line, adherent cells e.g. HEK293; suspension T cell (SupT1, MT4, H9) and primary hematopoietic cells (CD34+ cells))
  • Hands-on experience with Quantitative ELISA (Relative potency, titer, host cell protein, etc.)
  • Experience with industry GMP or GxP compliance and Client facing experience
  • Deviation investigation experience
  • Intermediate skills in applicable computer programs (Softmax, PLA, or FACSDiva)
  • Hand-on experience with equipment (FACSCanto, Cell sorters, Cell counter, Stemvision, automatic liquid handler, etc.)
  • Excellent verbal 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 and excellent multi-tasking abilities
  • Demonstrates a high level of initiative and leadership capabilities.
  • Effective coaching and training skills for complex and highly technical work
  • Highly, technically competent

Responsibilities

  • Act as subject matter expert (SME) for specific defined area(s) of the business.
  • For GLP studies, acts as Study Director.
  • Fully responsible for the technical conduct of a GMP/GLP study, as well as for the interpretation, analysis, documentation, and reporting of results.
  • Assure that appropriate technical specifications and standard operating procedures are followed.
  • Assure that all experimental data, including observations of unanticipated test system responses are accurately recorded and reviewed.
  • Assure that computerized systems used in the study have been validated or are under appropriate controls.
  • Utilizes problem solving/ trouble shooting skills.
  • Leads the completion of deviation investigation records 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.
  • 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.

Benefits

  • medical, vision, and dental insurance
  • life insurance
  • disability insurance
  • a 401(k) matching program
  • paid time off
  • paid holidays
  • short-term or long-term incentive compensation, including, but not limited to, cash bonuses
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