Test Facility Manager/ Prinicipal Scientist
Key Job Responsibilities: Serves as the principal technical manager (Test Facility Management) for the laboratory. The incumbent will be responsible for ensuring that all studies performed at the research facility meet the highest quality standards, full EPA and Global GLP compliance. Adherence to the sponsor’s timelines while ensuring the conduct of the study with application of sound scientific principles. Responsible to perform the duties of Lead Scientist, which include but are not limited to:
a) Provides oversight and management for environmental fate/ metabolism studies, and residue studies, for the purpose of registering/reregistering new/existing compounds for agrochemical/ specialty chemical /pharmaceutical/veterinary uses.
b) Mentor, advise and provide training to the scientific personnel on a range of topics including (but not limited to analytical chemistry (Mass spectrometry, HPLC, IR, UV, NMR, Raman etc.), Soil chemistry, protein chemistry, Guidelines as per OECD, and EPA, conduct of studies for residue and metabolism, GLP, regulatory affair issues, extraction procedures, new innovations in industry.
c) Communicate & trouble shoot techniques for all methods involving the following: gas and liquid chromatography, separations chemistry, radio tracer analysis (LSA and RFA-HPLC) and specialized trace level analytical procedures such as LC/MS, GC/MS, MS/MS, NMR, IR, or UV. Have hands-on proficiency with performing and troubleshooting, these techniques and associated instruments and equipment.
d) Perform (or oversee) method development and validation for residue and metabolism studies.
e) Review protocols and GLP reports for all studies in accordance with the expected Guidelines.
f) Ensure accurate interpretation of data and reviews reports produced by the Study Directors.
g) Ensure that the studies are performed and delivered efficiently and timely, to meet sponsors expectations.
h) Ensure that new software packages or modeling tools follow the experimental needs and GLP.
i) Study and work with new concepts and applies them to the work at hand.
j) Understand field trial studies as they relate to residue or metabolism, and the requirements set forth by guidelines and authorities.
k) Oversee all the research projects as per needs with sponsor requirements in mind.
l) Provide guidance to business development personnel, based on extensive knowledge of the agrochemical market sector and science involved.
m) Ensuring sponsor engagement and satisfaction. Provide guidance to sponsor on agency requirements and assists in agency meetings.
n) Provide thorough knowledge of analytical procedures and appropriate skills for interpreting data in residue,
environmental fate, and metabolism studies.
o) Provide sound knowledge of regulatory requirements in accordance with the guidance documents of FIFRA, GLP, US-FDA, and EPA etc.
p) Act as study director when necessary, for any of the services offered by the research facility.
q) Work with the Quality Assurance Unit in the assessment of procedures and results, providing awareness and
understanding of EPA GLP and data reporting requirements.
r) Oversee assignments relating to general laboratory safety, Rad safety, and waste disposal safety.
s) Responsible to track and resolve sponsor complaints.
Experience and competencies in the following is a Plus:
a) Master’s degree/PhD in Science.
b) 12+ years of experience with GLP E-fate and Metabolism as well as residues studies, as an eminent scientist in a CRO of a corporate regulatory research set up. Any experience of outsourcing and monitoring the studies would be valuable, in addition to the hands-on research experience.
c) Expertise and experience in extremely low level detection and quantification of parent compounds, impurities,
metabolites and degradants.
d) Strong fundamental knowledge of the chemistry for extraction and concentration of the moieties of interest from complicated matrices like soil, water, waste-water, plant and animal tissues.
e) Ability to tune mass spectrometers as part of an HPLC/MS system.
f) Understanding and interpreting the regulatory requirements in the sciences preferably on a global basis.
g) Flexibility to travel throughout the US, Canada and some international travel.