SENIOR SCIENTIST/MANAGER

Location
Birmingham, Alabama
Posted
Jun 10, 2019
Ref
Job ID 3443
Required Education
Doctorate/PHD/MD
Position Type
Full time

About Southern Research
We've created seven drugs that are helping win the war on cancer.  More are on the way.  When HIV threatened the work's future, we helped develop a course of treatment that changed the course of history.  We're creating better ways for you to have cleaner air and water.  Our technologies help men and women in uniform remain safe overseas.  We're developing methods to build energy efficient cars out of plant fiber that will get 80 mpg.  We are Southern Research.  We're taking on the world's hardest problems, and solving them.  This has been our mission since 1941.

Southern Research's Drug Development Division is a contract research organization (CRO) that provides commercial and government clients with a wide variety of nonclinical and clinical trial support services.  We offer an array of studies including both in vitro and in vivo testing of small molecule compounds, vaccines, biologics and other test articles in therapeutic areas, such as infectious disease, CNS and cancer.  Our nationally recognized team of dedicated individuals provides expertise and services spanning basic research to advanced studies under FDA GLP regulations.

General Summary
The Senior Scientist, Manager functions as a subject matter expert within the organization and has oversight of the scientific elements to ensure successful completion and/or implementation.   This position analyzes and reports results for publication or to sponsor; provides instruction to other members of the project team; and collaborates with other senior members of the staff on projects/research.  Knowledgeable of emerging trends and may contribute to and influence best practice within discipline. 

Key Responsibilities

  • Scientific Subject Matter Expert (SME) on commercial or large government contracts and grants.
  • May act as Study Director as needed.
  • Oversees assay development/validation experiments conducted in Operations.
  • Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and deliverables upon study completion.
  • In collaboration with the marketing support function in DDV, supports efforts to identify and win new business.
  • Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
  • May serve as PI on large government contract(s).
  • Participates in all required GLP training.

Position Specific

  • Works closely with Study Coordinator and/or Project Manager as Technical SME on assigned projects and interfaces with client’s scientific staff as appropriate.
  • May assume role of SD or PI on commercial and government contracts where appropriate.
  • Develops new assays; completes study designs as needed.
  • Oversees and serves as a technical advisor for lab operations to execute assay development and validation experiments.
  • Writes assay qualification and validation plans.
  • Supports troubleshooting assay issues in validation and sample analysis.
  • Participates in proposal generation and perform scientific/technical review.
  • Follows GLP practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
  • Ensures compliance to all regulatory and safety requirements for work with select agents.
  • Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements, and study protocols.
  • Accountable for some level of revenue generation.
  • Manages a team of scientists and/or technicians including hiring, performance management, assigning work, counseling and developing employees.

Requirements/Minimum Qualifications

  • PhD degree in life sciences discipline or MS plus over 10 yrs of prior experience, plus minimum of 4-6 yrs prior experience managing projects.
  • Proven track record of leading large government or commercial proposal generation and securement of funding. Has advanced the field of knowledge in their specialty. Their work directly impacts the present or future of the organization in significant ways.
  • Proficient in assay development and direct/mentor validation methodologies.  Must demonstrate full competency under regulated environment (e.g., GLP, BSL-3/SA).