Analytical Development Supervisor

Job Description

Job DescriptionDescription:

RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Analytical Development Supervisor to work with our growing Research and Development Team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team.

This position is located in East Windsor, NJ and is required to be onsite.

Requirements:

If this sounds interesting to you, it’s probably because up to this point you have:

• Bachelor’s or Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• 5+ years of experience in a pharmaceutical analytical laboratory, with at least 2 years in a supervisory or lead role.
• Strong knowledge of cGMP, GLP, ICH Q2(R2), and FDA guidelines for analytical method validation and transfer.
• Hands-on experience with HPLC, GC, UV-Vis, FTIR, dissolution, and stability testing for drug products and raw materials.
• Experience preparing and reviewing analytical protocols, validation reports, and CMC documentation for ANDA submissions.
• Strong problem-solving, documentation, and communication skills with attention to data integrity.
• Proven ability to lead, train, and develop analytical scientists and chemists.

The main expectations and responsibilities for this position are:

• Supervise and coordinate analytical method development, validation, and transfer for new and existing pharmaceutical products.
• Review and approve analytical data, test reports, protocols, and laboratory documentation for accuracy and compliance.
• Oversee stability studies, impurity profiling, and raw material characterization in accordance with ICH and regulatory standards.
• Ensure instrument calibration, qualification, and maintenance are completed and documented per SOPs.
• Collaborate with Formulation R&D, Quality Control, and Regulatory Affairs to support product development and submissions.
• Train, mentor, and evaluate laboratory personnel to maintain a high standard of scientific and regulatory performance.
• Support regulatory audits, method transfers, and technology scale-up activities with comprehensive analytical documentation.
• Drive continuous improvement in laboratory efficiency, data integrity, and analytical robustness.

If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation.

We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.