R&D Chemist II

About the Role

Perform research and development projects for established products and new products, including analytical test method validation, transfer, verification, deformulation, procedures, investigations, and other initiatives. Plan, organize, and manage resources on projects to ensure technical quality and schedule adherence.

Responsibilities

• Work in a GMP environment and generate GMP data.
• Utilize analytical techniques such as HPLC, UPLC, GC, Automatic Titrator, IR, DSC, ICP, and Mass Spectrometry.
• Perform analytical tests for R&D and QC as needed.
• Execute R&D projects for established and new product development, including formulation, laboratory investigations, and early process development.
• Evaluate new raw materials and components for quality and safety before implementation into exhibit batches and GMP production.
• Develop and validate analytical methods for pharmaceutical ingredients and dosage forms, including establishing specifications.
• Assist in drafting R&D and QC protocols and reports.
• Conduct research and development stability testing as necessary.
• Participate in the development and implementation of programs such as cleaning validation, process validation, GMP compliance, and equipment validation.
• Oversee and ensure reports, submission documentation, and development summaries are available for clients, partners, and health authorities (e.g., FDA).
• Perform job duties with minimal supervision.

Requirements

• Highly skilled in conducting analysis by LCMS, HPLC, UPLC, GC, FT-IR, UV/Vis spectroscopy, and wet chemistry techniques with little or no guidance.
• Strong interpersonal, verbal, and written communication skills.
• Effective organization, multitasking, and problem-solving skills.
• Proficient in Microsoft Word, Excel, PowerPoint, and Project.
• Specific expertise in research, product development, analytical method development, and troubleshooting through education and/or experience.
• Ability and willingness to adapt to shifting organizational and business demands.
• Demonstrated ability to manage oneself, show integrity, and be productive under pressure.
• Initiative and follow-through to implement, track, and achieve on-time project completion.
• Commitment to continuous improvement in all work activities.
• Ability to take strategic objectives, accept accountability, motivate and influence others, think globally, and leverage diversity.

Qualifications

Regionally accredited Master’s Degree in Chemistry and/or a minimum of 8–10 years of previous experience in a cGMP-related environment.

Working Conditions

• Typing, climbing, lifting (up to 15 lbs), reaching, and vision (20/20).
• Standing (10%), sitting (90%), walking, and hearing.