The Drug Safety Research and Development (DSRD) Global Risk Assessment Services (GRAS) Toxicologist is responsible for development of mutagenic and non-mutagenic impurity safety assessments and toxicological risk assessment support for Pfizer's business and throughout the continuum of drug development (preclinical, early clinical development to marketing and loss of exclusivity).
The GRAS toxicologist is a member of the GRAS network (a multidisciplinary team of safety subject matter experts from across DSRD), leading the development of integrated health-based risk assessments on impurities, excipients, contaminants, solvents, counterions, leachables and extractables in support of Pfizer's global portfolio.
The GRAS toxicologist works closely and in partnership with colleagues from Pharmaceutical Sciences and PGS and Global Medical in the development of safety positions as required. He/She also represents DSRD on internal impurity governance bodies (e.g. Pfizer Impurity Councils and PGS Area Quality Review Team).ROLE RESPONSIBILITIES
- Act as subject matter expert for in silico mutagenicity assessments, including conduct, peer review, and development of reports to support new drug applications and address regulatory queries.
- Develop high quality general toxicological risk assessments in support of the Pfizer portfolio.
- Represent DSRD (GRAS) on Pfizer Impurity Council.
- Represent GRAS at PGS Area Quality Review Team (AQRT) meetings, the Pfizer decision making body for market actions originating from quality and safety considerations for our marketed portfolio
- Apply a thorough understanding of the content and application of key external regulatory and scientific committee guidelines pertaining to a wide range of impurity-related matters associated with the drug substance, drug product, and the container closure system of parenteral products (e.g., ICH Q3A, ICH Q3B, ICH Q3C, ICH Q3D, ICH M7).
- Apply a thorough understanding of key internal Pfizer guidelines and their application pertaining to the control and qualification of impurities in drugs in development and those originating from packaging, product container closure, and in-line manufacturing components.
- B.S in chemistry, toxicological or related science with 9 years of experience
- M.S. in chemistry, toxicology or related science with 7 years of experience
- Ph.D. in chemistry, toxicology or related science
- Expert knowledge in the relationship between chemical structure, physico-chemical properties and the elicitation of toxicity, especially as it applies to evaluating mutagenic potential.
- Expertise in the use and interpretation of results from various in silico tools to aid in the risk assessment process.
- Strong leadership and interpersonal skills needed to effectively work within a matrix environment to rapidly address issues that often require multidisciplinary expertise.
- Strong multi-tasking skills
- Strong verbal and written communication skills
- Strong collaborator within a multi-disciplinary team.
- Expert knowledge in the risk assessment of impurity related matters (both small molecules and biologics would be desired)
- Expert knowledge in risk assessment of nitrosamine impurities.
NoneNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Global travel in support of impurity related matters for the Pfizer portfolio as needed.
Work Location Assignment: FlexiblePfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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Research and Development