Company Overview:

We are a growing 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/Sr. Chemists with 5-8 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 development, validation and transfer activities for raw materials, in-process, and finished product testing in accordance with current regulations and client requirements.
• Perform routine QC testing of solid oral dosage forms (assay, dissolution, content uniformity, related substances, moisture, etc.) using established methods (e.g., HPLC, GC, UV-Vis, KF).
• Draft and review validation protocols, validation summary reports, test results, SOPs, and related GMP documentation.
• Perform data analysis, interpret results, and ensure complete and accurate documentation that complies with cGMP and data integrity requirements.
• Support stability testing and ongoing product release activities.
• Participate in laboratory investigations, deviations, and OOS/OOT result resolution.
• Ensure laboratory equipment is calibrated and maintained according to SOPs.
• 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: 70-80K and comprehensive benefits package. 
• 2K for relocation assistance 
• 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