Staff Scientist, Analytical Development

Bayer AG; Morristown (NJ); Hybrid; USD 145,000 - 170,000; Full time

Benefits offered by this job

health care

vision

dental

retirement

PTO

sick leave

Job summary

Bayer HealthCare LLC is seeking a scientist to lead analytical development activities in Morristown, NJ. The role involves method development, validation, transfer to manufacturing sites, and interpretation of stability data for drug substances and products.

The candidate must hold a Master’s degree in pharmaceutics, pharmacy, chemistry or related field with several years of experience in analytical methods, including HPLC/LC-MS, and be able to work with CMOs/CDMOs.

Qualifications

• Master’s degree in pharmaceutics, pharmacy, chemistry or closely related field.
• 3+ years of experience designing analytical experiments in pharma or consumer products.
• Experience applying HPLC, LC-MS, GC, UV-Vis, FT-IR or AAS to validation/stability studies.

Responsibilities

• Design analytical experiments for method development, validation and transfer to manufacturing sites.
• Perform laboratory work.
• Prepare product specifications.
• Plan stability studies and interpret results.
• Present findings on the chemistry of pipeline products.
• Draft responses to deficiencies from EMA/FDA.

Skills

Analytical method design

Laboratory work

Data interpretation

Communication

Education

Master’s in Pharmaceutics/Pharmacy/Chemistry

Tools

HPLC

LC-MS

GC

UV-Vis

FT-IR

AAS

Job description

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Responsibilities and Requirements

• design analytical experiments for method development, method validation & method transfer to manufacturing sites
• perform laboratory work
• prepare product specifications
• plan stability studies & interpret results
• present findings regarding underlying chemistry of products in pipeline
• Requires Master’s in Pharmaceutics, Pharmacy, Chemistry or closely-related field & 3 yrs experience designing analytical experiments in the pharmaceutical and/or consumer products industry
• applying HPLC, LC-MS, GC, UV-Vis, FT-IR and/or AAS to validation and/or stability studies for pharmaceuticals
• performing method development & validation of pharmaceutical tests, including assay, impurities, and dissolution
• evaluating & interpreting stability data
• performing in‑vitro release testing of topical and/or transdermal dosage forms
• managing CMOs & CDMOs to deliver comprehensive and compliant analytical development, validation, and stability studies for drug substances and/or drug products
• drafting responses to deficiencies from EMA, ROW, and/or FDA- IR letters
• performing Accelerated Stability Assessment Program stability studies on drug products
• drafting & closing OOT and OOS investigations, CAPA’s and lab related deviations using Veeva

Telecommuting permitted from home office location within reasonable commuting distance of Morristown, NJ up to 1 day per wk. Up to 10% U.S. and int’l travel req’d.

Salary Range: Employees can expect to be paid a salary between $145,000.00 to $170,000.00. Additional compensation may include a bonus or commission (if relevant).

Additional benefits include:

• health care
• vision
• dental
• retirement
• PTO
• sick leave

The offered salary may vary within this range based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

Bayer HealthCare LLC is an Equal Opportunity Employer/Disabled/Veterans

Bayer HealthCare LLC is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

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