Senior Process Chemist
The APIIC seeks an experienced Process Chemist with strong process development skills willing to acquire and utilize advanced manufacturing to create world-class commercial API processes. The successful candidate has a track record of high performance in process development from the lab into commercialization. They will be able to conduct experiments related to API manufacturing using appropriate safety guidelines consistent with safety practices.
The API Innovation Center at Cortex (APIIC) is a non-profit entity in St. Louis, Missouri, dedicated to delivering market-competitive commercial supply of U.S.-made Active Pharmaceutical Ingredients (APIs) to strengthen the domestic pharmaceutical supply chain. The focus is on de-risking the commercialization and adoption of advanced manufacturing technologies, such as continuous flow chemistry, to successfully re-shore domestic production of APIs.
Primary Duties and Responsibilities:
- This position will work closely with internal and external Subject Matter Experts, Analytical Chemists, Process Engineers and a Project Manager under minimal supervision.
- The senior process development chemist will provide the technical lead for development and scale-up of advanced API manufacturing processes utilizing state-of -the-art technology.
- Work with external subject matter experts on advanced manufacturing process techniques to acquire and stay abreast of latest technologies and federal regulations.
- Utilize advanced manufacturing techniques to create efficient commercial API processes.
- Provide technical leadership for transfer of customer API processes to manufacturing scale under GMP.
- Identify most efficient chemical transformation to acquire target API 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 (DMF) to the FDA
Personal Characteristics:
- Behave Ethically: Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns 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.
- Focus on Client Needs: Anticipate, understand, and respond to the needs of internal and external stakeholders to meet or exceed their expectations within the organizational parameters.
- Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve challenges, and make decisions that enhance organizational effectiveness.
- Lead: Positively influence others on the team to achieve results that are in the best interest of the organization.
- Make Decisions: Assess situations to determine the importance, urgency and risks, and make clear decisions which are timely and in the best interests of the organization.
- Organize: Set priorities, develop a work schedule, monitor progress towards goals, and track details, data, information and activities.
- Plan: Determine strategies to move the project and organization forward, set goals, create and implement actions plans, and evaluate the process and results.
- Solve Problems: Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem.
Qualifications:
- Track record of high performance in process development from lab to pilot plant and into commercialization, preferably APIs.
- Experience with successful validation of API chemical processes and support of DMF submissions.
- Broad organic chemistry knowledge base and understanding of chemical transformations.
- FDA Q7A Good Manufacturing Practice Guidance for APIs.
- Ability and desire to incorporate automation and new technology in process development.
- Excellent laboratory skills and good mechanical aptitude.
- Working knowledge of physical chemist and chemical engineering.
- Solid understanding of analytical instrumentation and techniques as well as PAT.
- Ability to work effectively as an individual, within a team and with internal and external partners.
Knowledge, Skills, and Abilities:
- Solid organic chemist with strong process development skills willing to acquire and utilize advanced manufacturing to create world class commercial API processes.
- Experience with Q7A, validation, DMF support and commercial technical transfers is preferred.
- Works well with other disciplines (safety, analytical chemist, engineers, and regulatory affairs).
- Ability to work independently in a fast-paced organization.
Education:
- Ph.D. in Organic Chemistry with 3 years of related experience, a Master of Science (theses is preferred) in Organic Chemistry with 5 or more years of experience or a Bachelor of Science in Chemistry with 10 years of directly related experience.
Location:
St. Louis, MO
Application Requirements:
To apply, please provide a cover letter and resume.