Company Overview:

We are a growing small pharmaceutical Contract Development and Manufacturing Organization (CDMO) specializing in solid oral dosage forms. We support clients with high-quality, compliant drug manufacturing and testing services in a fast-paced, collaborative environment.

Position Summary:

We are seeking an experienced Chemists with 1-5 years of proven expertise in method development, validation and transfers for solid dosage pharmaceutical products. These roles focus on executing and documenting analytical method validations, routine QC testing, and ensuring full compliance with cGMP and regulatory standards.

Key Responsibilities:

• Plan, execute, and document analytical method verification and transfer activities to support product development and commercial requirements.
• Perform method transfers and verifications for GC residual solvent testing in accordance with USP compendial procedures and customer-validated methods.
  in accordance with USP compendial procedures and customer-validated methods.
• Perform routine QC testing of solid oral dosage forms, in-process samples and drug substance (assay, dissolution, content uniformity, related substances, moisture, etc.) using established methods (e.g., HPLC, GC, UV-Vis, KF).
• Conducted stability studies for drug substances and drug products to support product development and ANDA submission activities.
• Lead or support investigations for analytical issues, QC troubleshooting, regulatory queries, OOS/OOT events, and method performance concerns.
• Prepare technical documents, including justifications, development reports, protocols, analytical reports, change controls, and investigation reports.
• Performed daily operation, calibration, and maintenance of analytical laboratory equipment in a cGMP environment.
• Assist with audits and inspections as needed.
• Train and mentor junior analysts on proper QC testing and validation procedures.

Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 1–5 years of direct experience in method development, validation and transfer and routine testing in a cGMP pharmaceutical environment.
• Strong working knowledge of compendial methods (USP/EP) for solid dosage forms.
• Proficiency with analytical techniques such as HPLC, GC, dissolution, and wet chemistry.
• Deep understanding of ICH guidelines, FDA requirements, and cGMP standards.
• Excellent documentation, problem-solving, and communication skills.
• Experience in a CDMO or contract lab setting is a plus.

What We Offer:

• Salary: 60-70K and comprehensive benefits package. 
• 10 days PTO, health, vision, dental, matching 401K
• A supportive, team-oriented work environment with opportunities for growth.
• The opportunity to contribute to high-quality pharmaceutical manufacturing and testing