Staff Scientist, Analytical Development

Bayer; 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 in Morristown, NJ is seeking a Staff Scientist in Analytical Development to design experiments for method development, validation, and transfer to manufacturing sites. The role involves lab work, planning stability studies, and interpreting data to support drug substances and products.

Requires MS in pharmaceutics/pharmacy/chemistry or related field with 3 years of experience; telecommuting up to 1 day per week from a home office within commuting distance of Morristown, NJ,

Qualifications

• Design analytical experiments for method development and validation.
• Apply HPLC, LC-MS, GC, UV-Vis, FT-IR and/or AAS to validation and stability studies.
• Interpreting stability data and contributing to regulatory responses (EMA/FDA).

Responsibilities

• Plan and execute stability studies and in vitro release testing for topical/drug products.
• Present findings regarding product chemistry to internal teams.
• Manage CMOs/CDMOs to ensure compliant analytical development and validation.
• Draft and close investigations (OOT/OOS) and CAPAs as needed.

Skills

Analytical method development

HPLC

LC-MS

GC

UV-Vis

FT-IR

AAS

Method validation

Stability testing

In vitro release

CMO/CDMO management

Regulatory responses

OOT/OOS investigations

Education

Master’s in Pharmaceutics/Pharmacy/Chemistry or related

Bachelor’s with 5+ years progressive experience

Tools

Veeva

Job description

Staff Scientist, Analytical Development for Morristown, NJ

to 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. Would also accept Bachelor’s degree in above-stated fields and 5 yrs progressive post‑Bachelor’s stated exp. 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, etc. 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.

Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

• Division: Consumer Health
• Reference Code: 889975
• Functional Area: R&D
• Location: Morristown, NJ
• Employment Type: Regular