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CSS Scientific

Senior Analytical Chemist

CSS Scientific, Brownsburg, Indiana, United States, 46112

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Senior Analytical Chemist – Contract‑to‑Hire (Brownstown, IN) We are seeking an experienced and detail‑oriented

Senior Analytical Chemist

to join our client’s team on an onsite, contract‑to‑hire basis. The role focuses on performing advanced laboratory testing and method development for raw materials, packaging components, in‑process samples, and finished products, ensuring compliance with cGMP standards while driving innovation in analytical testing and method validation.

Compensation

$38.00–$47.00 per hour (based on experience)

Work Schedule

Monday through Friday, 8:30 am – 5:30 pm

Key Responsibilities

Perform routine and complex chemical and physical tests on raw materials, active pharmaceutical ingredients (APIs), packaging, in‑process, and finished products.

Utilize advanced techniques including HPLC, GC, dissolution, Karl Fischer titration, wet chemistry, and particle size analysis.

Develop and validate analytical test methods in alignment with ICH, FDA, and USP requirements with minimal supervision.

Conduct analytical research to evaluate new raw materials, packaging materials, and reference standards.

Draft and revise SOPs for laboratory processes and ensure compliance with regulatory guidelines.

Prepare technical documents to support regulatory submissions (IND, NDA, ANDA).

Troubleshoot laboratory methods and instrumentation, recommending and implementing improvements.

Provide peer review of analytical data and ensure accuracy of laboratory records.

Train and mentor junior chemists on instrumentation, methodology, and best practices.

Support method transfers and contribute technical insight for the purchase of new laboratory equipment.

Collaborate with cross‑functional teams to ensure testing and reporting timelines are met.

Qualifications and Skills

Bachelor’s degree in Chemistry or related field required; advanced degree preferred.

8–12 years of experience in pharmaceutical product analysis within a cGMP‑regulated laboratory.

Strong expertise in method development, method validation, and analytical instrumentation (HPLC, GC, dissolution, wet chemistry, ICP‑MS, particle size analysis).

In‑depth knowledge of cGMP, FDA, ICH, and USP/NF guidelines.

Proven ability to write and edit technical documentation and regulatory reports.

Skilled in troubleshooting laboratory instrumentation and analytical methods.

Proficiency in Microsoft Word and Excel, LIMS, and Chromatography Data Systems.

Excellent communication skills with the ability to lead projects and mentor junior analysts.

Strong organizational, problem‑solving, and time‑management abilities.

Why Join Us? This opportunity provides the chance to work on complex, cutting‑edge projects within a collaborative pharmaceutical laboratory environment. You’ll play a critical role in developing analytical methods that directly impact drug product quality, while being part of a team that values technical expertise, mentorship, and professional growth.

About CSS Scientific Contemporary Staffing Solutions (CSS) is a trusted leader in providing contract, temporary, temp‑to‑hire, and direct hire staffing solutions. With decades of experience, we’ve grown from a staffing agency to a nationwide provider of workforce management solutions. Our niche recruitment expertise spans Accounting & Finance, Call Center & Office Support, Human Resources, Sales & Marketing, and Information Technology.

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