Scientist III, Analytical R&D

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 80,000 - 100,000; Full time

Job summary

Granules Pharmaceuticals, Inc. seeks a qualified professional in Chantilly, Virginia, to manage method development, validation, and technical transfer activities for API and finished products. The ideal candidate will oversee analytical techniques, ensuring compliance with FDA and GMP standards while supervising a team within Analytical R&D.

A Master's degree in Analytical Chemistry or related field with at least 5 years of experience (or a PhD with 3+ years) is essential. The role also requires excellent communication skills and problem-solving abilities, along with knowledge of pharmaceutical regulations.

Qualifications

• 5+ years experience in analytical development or PhD with 3+ years required.
• Experience with small molecule solid oral dosage analytical development is required.
• Functional understanding of small molecule analytical development and associated regulatory and quality requirements.

Responsibilities

• Plan and execute method development and validation for API and finished products.
• Oversee analytical techniques and troubleshooting for Analytical R&D.
• Prepare and review SOPs to support laboratory GMP function.

Skills

Knowledge of API, excipient and finished product in generic pharmaceuticals

Hands-on experience with HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size

Excellent verbal and written communication skills

Excellent problem solving and interpersonal skills

Education

Master's degree in Analytical Chemistry or related field with 5+ years of experience

PhD with 3+ years of experience

Job description

Job Type: Full‑time

Description

• Plan and execute method development, method validation and tech transfer activity for API, excipient, package components and finished product.
• Oversee analytical techniques, interpretations of analytical data, problem solving and troubleshooting as required for Analytical R&D activities.
• Prepare and review SOPs, protocols, reports to support laboratory GMP function in compliance with FDA, ICH and other regulatory guidance.
• Plan, review and implement additional studies (e.g., cleaning validation, photostability, any in‑use studies, multimedia dissolution, shipping study, etc.).
• Plan and design of experiments toward answering CMC deficiencies responses.
• Perform investigations (out of trend, out of specification and laboratory deviations) as per SOP.
• Conform to all training requirements, including company required and regulatory requirements.
• Manage the AR&D function in the laboratory to ensure cGMP compliance.
• Provide regular timely reports, interpret analytical data and present results to the manager AR&D and Head as needed.

Management Responsibility

• Review staff's performance regularly and develop team members to continually enhance both individual and overall work team performance.
• Take an active role in identifying training needs, challenge and develop both direct and indirect reports in their positions for future opportunities.

Reports to

Manager to Analytical R&D.

Knowledge & Skills

• Knowledge of API, excipient and finished product in generic pharmaceuticals.
• Hands‑on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size.
• Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
• In‑depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance.
• Excellent verbal and written communication skills.
• Excellent problem solving and interpersonal skills.

Experience & Education

• Master's degree in Analytical Chemistry or Chemistry or related field with 5+ years OR PhD with 3+ years of experience.
• Experience with small molecule solid oral dosage analytical development is required.

Physical Requirements / Working Environment

• Must be able to stand for long periods of time (up to 12‑hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
• Vision – ability to see details at close range (within a few feet of the observer).