Analytical R&D Lead — GMP Drug Development & Validation

Granules Pharmaceuticals Inc.; Chantilly, Northern (VA, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Granules Pharmaceuticals Inc. is seeking a senior Analytical Development Scientist to lead method development, validation and tech transfer for API, excipient, and finish product at our Chantilly, VA site. You will oversee analytical R&D activities and ensure cGMP compliance in a fast-paced environment.

Ideal candidates hold a B.S. in Analytical Chemistry or Chemistry with 10+ years GMP/GLP experience in small molecule solid oral formulations, or an MS/PhD with 7+ years, and hands-on expertise

Qualifications

• Hands-on experience with small molecule analytical development and regulatory requirements.
• Knowledge of cGMP and ICH guidelines governing pharma analytics.
• Experience with method development, validation and tech transfer.

Responsibilities

• Manage day to day laboratory operations and supervise group activities.
• Plan and execute method development, validation and tech transfer for API, excipient, and finished product.
• Oversee analytical data interpretation, troubleshooting, and problem solving.
• Prepare and review SOPs, protocols, and reports for GMP compliance.
• Coordinate in-process release testing and stability testing with QA/QC.
• Plan studies (e.g., cleaning validation, impurity testing, photostability).
• Collaborate with product development, regulatory, quality, and contract labs.
• Review PDR and QOS to support regulatory filings for ANDAs.
• Investigate OOT/OOS deviations and implement CAPAs.
• Ensure AR&D compliance and train staff as required.

Skills

HPLC

GC

KF

MS

Dissolution

Spectroscopy

Particle size

Analytical development

Regulatory knowledge

Communication

Education

Bachelor's degree in Analytical Chemistry or Chemistry

10+ years GMP/GLP experience (BS/BA)

MS/PhD with 7+ years GMP/GLP

Tools

MS Project

Job description

Granules Pharmaceuticals Inc. is seeking a senior Analytical Development Scientist to lead method development, validation and tech transfer for API, excipient, and finish product at our Chantilly, VA site. You will oversee analytical R&D activities and ensure cGMP compliance in a fast-paced environment.

Ideal candidates hold a B.S. in Analytical Chemistry or Chemistry with 10+ years GMP/GLP experience in small molecule solid oral formulations, or an MS/PhD with 7+ years, and hands-on expertise