Senior Scientist DSRD Global Risk Assessment Services Toxicologist

ROLE SUMMARY

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.

BASIC QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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.

PHYSICAL/MENTAL REQUIREMENTS

None

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel in support of impurity related matters for the Pfizer portfolio as needed.

Work Location Assignment: Flexible

Pfizer 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

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

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