Lead Analytical R&D Scientist, Small Molecule API

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

Job summary

Granules Pharmaceuticals Inc. is seeking an experienced professional for an Analytical R&D position in Chantilly, Virginia. The role involves method development, method validation, and ensuring compliance with GMP regulations.

Ideal candidates should possess a Master's or PhD degree in Analytical Chemistry and have hands-on experience with various analytical techniques. Responsibilities include managing laboratory functions and reporting on analytical findings to ensure quality and efficacy in drug development.

Qualifications

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

Responsibilities

• Plan and execute method development, method validation, and tech transfer activity.
• Oversee analytical techniques and troubleshoot as necessary.
• Prepare and review SOPs, protocols, and reports for GMP compliance.
• Manage the AR&D function in the laboratory to ensure cGMP compliance.
• Provide regular reports and present analytical data to management.

Skills

Knowledge of API, excipient, and finish product in generic pharmaceuticals

Hands-on experience with HPLC, GC, KF, MS

Functional understanding of small molecule analytical development

In-depth understanding of GMPs and regulatory guidance

Excellent verbal and written communication skills

Excellent problem solving and interpersonal skills

Education

Master's degree in Analytical Chemistry or related field

PhD in Analytical Chemistry or related field

Job description

Granules Pharmaceuticals Inc. is seeking an experienced professional for an Analytical R&D position in Chantilly, Virginia. The role involves method development, method validation, and ensuring compliance with GMP regulations.

Ideal candidates should possess a Master's or PhD degree in Analytical Chemistry and have hands-on experience with various analytical techniques. Responsibilities include managing laboratory functions and reporting on analytical findings to ensure quality and efficacy in drug development.