Senior Manager, Analytical R&D — GMP & CMC Focus

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 100,000 - 130,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly/Manassas, VA seeks an experienced Analytical R&D leader to oversee day-to-day lab operations and drive method development, validation, and tech transfer for APIs and finish products.

The role requires strong GMP/GLP experience in small molecule analytics, with hands-on instrumental expertise (HPLC, GC, KF, MS, dissolution, spectroscopy, particle size) and collaboration across Product Development, Regulatory Affairs, QA, and Supply Chain.

Qualifications

• Bachelor's degree in Analytical Chemistry or Chemistry or related field; 10+ years GMP/GLP in small molecule analytics.
• MS/PhD with 7+ years GMP/GLP in small molecule solid oral formulation analytics.
• Experience with API, excipient, and finish product analytical development.

Responsibilities

• Manage day to day laboratory operations and supervise group’s daily activities.
• Plan and execute method development, validation and tech transfer for API, excipient, package components and finish product.
• Oversees analytical techniques, data interpretations, problem solving and troubleshooting for Analytical R&D.

Skills

HPLC

GC

KF

MS

Dissolution

Spectroscopy

Particle size analysis

Education

Bachelor's degree in Analytical Chemistry or Chemistry or related field

MS/PhD with GMP/GLP pharmaceutical experience

Job description

Granules Pharmaceuticals Inc. in Chantilly/Manassas, VA seeks an experienced Analytical R&D leader to oversee day-to-day lab operations and drive method development, validation, and tech transfer for APIs and finish products.

The role requires strong GMP/GLP experience in small molecule analytics, with hands-on instrumental expertise (HPLC, GC, KF, MS, dissolution, spectroscopy, particle size) and collaboration across Product Development, Regulatory Affairs, QA, and Supply Chain.