Description:

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.

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.).

Additional Skills & Qualifications:

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 – application of 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.

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.