Scientist, Analytical R&D

About the role

The Scientist-2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment.

Responsibilities

• Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
• Develops and optimizes new and existing analytical methods for qualification and release testing of products.
• Develops stability indicating methods and performs methods validation.
• Provides timely responses to all internal and external inquiries.
• Ensures deadlines are met for product development schedules, and checks that technical and compliance requirements are met.
• Evaluates, recommends, and implements new analytical technologies and instrumentation for testing.
• Assists with training other members of the analytical development team.
• Stays abreast of new developments in analytical technologies.
• Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.

Qualifications

Education:

• Bachelors Degree (BA/BS) Chemistry or related science - Required
• Master Degree (MS/MA) Chemistry or related science - Preferred

Experience:

• 3 years or more in pharmaceutical experience (with Bachelor's Degree)
• 1 year or more in pharmaceutical experience (with Master's Degree)

Specialized Knowledge:

• Broad knowledge of modern analytical equipment and techniques.
• Extensive experience in cGMP laboratory testing.
• Hands-on experience with HPLC, GC, TLC, and MS.
• Methods development experience.
• Experience writing the standard operating procedures (SOPs) and test methods.

Skills

Broad knowledge of modern analytical equipment and techniques; extensive cGMP laboratory testing experience; hands‑on expertise with HPLC, GC, TLC, and MS; methods development; SOP and test method authoring.

Benefits

Short‑term incentive opportunity, such as a bonus or performance‑based award, available within the first 12 months.

Pay

The base salary for this position ranges from $75,000 to $90,000 per year.