Direct Hire Lead Scientist Opportunity! Serve as Principal Technical Manager of a Laboratory!
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 apply 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
q) Work with the Quality Assurance Unit in the assessment of procedures and results, providing an 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.
a) Master's degree/PhD in Science. Bachelor's plus applicable experience considered.
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, wastewater, 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.