Lead Scientist, Analytical R&D

Amneal

5d

About The Position

Research Scientist III, Analytical Method Development fulfills a critical role in supporting the analytical development and validation of testing methods for the Analytical R&D laboratory. This individual leads analytical development, qualifications, validations for active pharmaceuticals, excipients, dosage forms, release activities and in-process analytical testing services in support of the formulation development department. Independently manages analytical methods development/validation/transfer projects for new products. This individual technically supervises, coaches and reviews the work of analytical development team members. Additionally, this individual helps drive advances in analytical capabilities for all analytical technology, qualifies and maintains analytical equipment.

Requirements

• Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences - Required
• 9 years or more in pharmaceutical experience (with Masters Degree)
• 5 years or more in pharmaceutical experience (with Ph.D.)
• Broad knowledge of modern analytical equipment and techniques.
• Extensive experience in cGMP laboratory testing.
• Hands-on experience with HPLC, GC, TLC, and MS.
• Method development and validation experience.
• Experience writing the standard operating procedures (SOPs) and test methods.
• Experience with regulatory document compilation.

Nice To Haves

• Ph. D. in Pharmaceutical sciences or other relevant field - Preferred
• Knowledge of Raman, ICP-MS, Mastersizer - Preferred.
• Inhalation/nasal product testing- Intermediate.
• Knowledge to ACI, NGI and other analytical techniques for inhalation drug products- Preferred.

Responsibilities

• Performs work at a level considered subject matter expert.
• Drives research strategy including independently managing analytical method development/validation (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for routine analysis.
• Leads high-visibility technical projects with focused deliverables.
• Development and optimization of new and existing analytical methods for qualification and release testing of products.
• Interpret and communicate complex experimental results, present technical findings to internal R&D & management teams and document findings in internal technical reports and/or external publications.
• Responds to internal and external inquires by performing advanced data generation, analysis and complicated problem solving independently
• Technically supervise and train staff and group members aimed at developing technical capabilities.
• Expand analytical capabilities of the Analytical Group.
• Conducts independent assessment of method performance to address scientific questions or problems.
• Drives scientific and technical innovation, including through external collaboration and partnership.
• Generates well-structured, accurate technical documents reporting the results obtained in his/her experiments and the conclusions that can be withdrawn from them including relevant recommendations for next steps.
• Stays abreast of new developments in analytical technologies.
• Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.
• Leads team members on assigned projects, as required.
• Participates and leads scientific discussions on projects with cross-functional team.
• Plan and distribute work plan for the team based on priority as and when required.
• Procurement of necessary requirement to initiate any new project work.

Benefits

• health and insurance benefits
• 401(k) matching contribution
• employee well-being programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior