JOB TITLE: Analytical Chemistry Lead
JOB TYPE: Contract
LOCATION: Fully Remote – East Coast Preferred
START DATE: November/December 2026
SHIFT: Monday–Friday, 9:00 AM–5:00 PM ET
We are seeking an experienced Analytical Chemistry Lead to oversee analytical development, method validation, and technical activities supporting product development programs. This role focuses on evaluating analytical results, resolving testing challenges, and ensuring methods and documentation meet quality and regulatory standards. The ideal candidate will bring strong technical expertise and the ability to independently guide analytical activities.
Responsibilities- Oversee analytical method development, optimization, qualification, and validation, including technical review and approval of methods and validation reports.
- Review and interpret analytical data for active pharmaceutical ingredients (APIs) and finished drug products, evaluating results against established specifications.
- Troubleshoot analytical testing issues, investigate unexpected results, and recommend appropriate technical solutions.
- Provide analytical expertise for Chemistry, Manufacturing, and Controls (CMC) activities, supporting method evaluation and product development decisions.
- Oversee bioanalytical activities supporting nonclinical and clinical programs, ensuring methods satisfy scientific and regulatory standards.
- Review and prepare analytical documentation for regulatory filings, including CMC submissions and annual reporting.
- Ensure analytical activities, records, and documentation meet data integrity standards and applicable GLP/GMP requirements.
- Coordinate analytical activities with internal teams and external laboratories, tracking project timelines and technical deliverables.
Qualifications- Bachelor's or Master's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific field.
- 10+ years of relevant experience in analytical development, CMC, or related regulated development environments. Experience limited to routine QC testing is insufficient.
- Strong experience developing, optimizing, qualifying, and validating analytical methods, including evaluating technical reports and validation documentation.
- Demonstrated experience interpreting API and drug product testing data, assessing specifications, and identifying potential quality issues.
- Proven ability to troubleshoot analytical testing problems, support laboratory investigations, and recommend effective solutions.
- Strong understanding of CMC principles, regulatory documentation, and applicable GLP/GMP requirements.
- Experience independently overseeing analytical activities and collaborating with external laboratories, manufacturers, and cross-functional technical teams.
EOE STATEMENT:
We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.