Senior Analytical Chemist

The API Innovation Center (APIIC) seeks a principal analytical chemist to help shape the future of pharmaceutical innovation. In this pivotal role, you will lead the development and qualification of cutting-edge analytical test methods for raw materials, intermediates, and active pharmaceutical ingredients (APIs) within our dynamic R&D environment.

The successful candidate will serve as a technical authority, leveraging advanced technologies to design stability-indicating methods and establish rigorous acceptance criteria for APIs. Collaborating closely with internal teams and external partners, you will guide the seamless transfer of analytical methods under Good Manufacturing Practices (GMP), while upholding the highest standards of regulatory compliance.

This is more than a job—it’s an opportunity to drive scientific excellence and help deliver high-quality, domestically produced medicines that improve and/or save lives.

Work closely with internal and external subject matter experts, process chemists, process engineers, and project managers under minimal supervision.

Provide the technical lead for development and validation of analytical test methods utilizing state-of
-the-art technology. Specifically, develop and validate LC, LC/MS, GC/MS methods for drug substances, drug products, and impurities.

Work with external subject matter experts and stay abreast of the latest technologies and applicable federal regulations. Introduce innovative analytical approaches to facilitate optimal decision-making.

Provide technical leadership for transfer of a complete set of analytical test methods to contract manufacturing organizations for manufacturing under cGMP.

Propose specifications for control of raw materials, intermediates, in-process testing, and drug substances, based on scientific justification that provides robustness to our processes.

Execute and verify compendial test methods and develop specialized methods to support lab scale and commercial API manufacturing processes.

Provide identification and structural characterization of unknown impurities and degradants of small molecules.

Preparation and review of relevant documentation including, but not limited to, reports, specifications, and batch records, as well as updating relevant lab records.

Assists in the creation and submission of Drug Master Files (DMFs).

Behave Ethically:
Understand ethical behavior and business practices and ensure that your own behavior and the behavior of others is consistent with these standards and align with the values of the organization.

Build Relationships:
Establish and maintain positive working relationships with others, both internally and externally, to achieve the goals of the organization.

Communicate Effectively:
Speak, listen, and write in a clear, thorough, and timely manner using appropriate and effective communication tools and techniques.

Creativity/Innovation:
Develop new and unique ways to improve operations of the organization and to create new opportunities.

Foster Teamwork:
Work cooperatively and effectively with others to set goals, resolve challenges, and make decisions that enhance organizational effectiveness.

Make Decisions:
Assess situations to determine the importance, urgency, and risks, and make clear decisions that are timely and in the best interests of the organization.

Organize:
Set priorities, develop a work schedule, monitor progress toward goals, and track details, data, information, and activities.

Preferred:
Ph.D. in Analytical Chemistry with 5 years of related experience, a Master of Science in Analytical Chemistry with 7 or more years of experience or a Bachelor of Science in Chemistry with 10 years of directly related experience.

Solid, hands-on analytical chemistry skills in developing compendial and novel test methods.

Experience with test method validation, DMF support, and technical transfers are preferred.

Work well with other disciplines (safety, process chemists, engineers, and regulatory affairs).

Track record of high performance in analytical method development from lab to pilot plant and into…