Senior Analytical R&D Manager – GMP & Drug Substance

Smart Media; Chantilly (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, VA is seeking an experienced Manager, Analytical R&D to lead day-to-day laboratory operations and advance method development for small molecule products.

The role requires 10+ years GMP/GLP pharma experience, hands-on analytical skills (HPLC, GC, KF, MS, dissolution, spectroscopy), and strong leadership to drive regulatory-aligned development and CMC submissions. On-site role with competitive benefits.

Qualifications

• Bachelor's in Analytical Chemistry or Chemistry with 10+ years GMP/GLP pharma exp.
• Or MS/PhD with 7+ years GMP/GLP pharma exp.

Responsibilities

• Manage day-to-day laboratory operations and supervise the group.
• Plan method development, validation and tech transfer for API, excipients and finished product.
• Oversee analytical techniques and interpretation of data for AR&D activities.
• Prepare SOPs, protocols and reports to support GMP function and regulatory guidance.
• Plan in-process release testing and coordinate with QC for stability testing.
• Plan and implement studies (e.g., cleaning validation, E/L, etc.).
• Use project management tools to support AR&D projects.
• Coordinate with external labs and vendors for testing.
• Collaborate with product development, regulatory affairs and QA.
• Support ANDA submissions and commercial launches.
• Review PDR, QOS and regulatory documents for filings.
• Investigate OOT/OOS deviations and implement CAPA.
• Ensure cGMP compliance and train staff.

Skills

Analytical chemistry

HPLC

GC

KF

MS

Dissolution

Spectroscopy

Particle size

cGMP/regulatory

Team leadership

Education

Bachelor's in Analytical Chemistry or Chemistry

MS/PhD with GMP/GLP pharma exp

Job description

Granules Pharmaceuticals Inc. in Chantilly, VA is seeking an experienced Manager, Analytical R&D to lead day-to-day laboratory operations and advance method development for small molecule products.

The role requires 10+ years GMP/GLP pharma experience, hands-on analytical skills (HPLC, GC, KF, MS, dissolution, spectroscopy), and strong leadership to drive regulatory-aligned development and CMC submissions. On-site role with competitive benefits.