The Lead Chemist will report to the Senior Director of Upstream Development. The successful candidate will serve as a key functional member and will drive the development of new products and/or support of life-cycle management products including the preparation of reports and documents for regulatory submissions.

Work Schedule: Monday - Friday 7:00am - 4:00pm. Working hours could be adjusted.

• Support R&D initiatives and related project teams through development and implementation of robust drug product formulations and processes.
• Support lifecycle management initiatives of existing products.
• Design, synthesize, purify, and characterize drug candidates based on a risk-based approach to drug development.
• Write and provide peer review of technical documents including those supporting CMC regulatory submissions.
• Participate in development project teams as CMC functional area representative and SME.
• Interface and collaborate with research and operation-focused functional teams including manufacturing and quality functions.
• Execute the development plan to support global submissions.
• Maintain a high-level of understanding of global (ICH, FDA, EMA) regulatory requirements (in particular Chemistry, Manufacturing, and Controls) including those for filing and approval of investigational and commercial products.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor of Science degree in Chemistry, Chemical Engineering, Biochemistry, or a related field required. Master of Science or PhD strongly preferred. Work experience considered in lieu of a degree.
• Eight or more years of relevant work experience in a industrial pharmaceutical or biotechnology CMC/cGMP environment is required.
• Proficiency in writing scientific reports and providing critical peer review.
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions.
• Ability to demonstrate a strategic mind-set with the ability to translate strategies into operational plans.
• Strong attention to detail with a technical mind-set - applicationof product knowledge is imperative to success.
• Behavioral requirements for success in this position include: critical thinking, excellent communication skills, team-focused attitude, and a strong ethic.
• Experience with cGMP manufacturing.
• Experience preparing CMC regulatory filings.
• Radiopharmaceutical experience highly preferred.
• Experience in New Product Development including knowledge of Regulatory Affairs.
• Pharmaceutical industry experience is required with a strong familiarity with cGMP, FDA, EMA, USP, NRC, and ICH guidelines.
• Knowledgeable about the use of New Product Development Processes and introduction of these products to market.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.