Senior Process Chemist

The API Innovation Center seeks an experienced Senior Process Chemist who will be responsible for developing and scaling up advanced manufacturing processes for pharmaceutical active pharmaceutical ingredients (APIs). The successful candidate will provide technical leadership, utilizing state-of-the-art technologies such as continuous flow chemistry, to create efficient commercial API manufacturing processes. This role requires working closely with internal and external experts, managing the transfer of processes to manufacturing scale under Good Manufacturing Processes (GMP), and ensuring compliance with federal regulations.

The API Innovation Center is a nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to revolutionizing pharmaceutical development through cutting-edge chemical and semi-synthetic research. By developing and leveraging advanced manufacturing technologies, the API Innovation Center aims to create sustainable and efficient routes for producing vital pharmaceuticals in the U.S. Through investments in and collaboration along the supply chain, The API Innovation Center’s model contracts leading U.S.

-based specialists within their pharmaceutical ecosystem to develop and manufacture APIs, ensuring high-quality domestically produced pharmaceuticals.

• Work closely with internal and external subject matter experts, analytical chemists, process engineers and a Project Manager under minimal supervision.
• 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 and stay abreast of latest technologies and applicable federal regulations.
• Utilize advanced manufacturing techniques to create efficient commercial API manufacturing processes.
• Provide technical leadership for transfer of customer API processes to manufacturing scale under GMP.
• Identify the most efficient chemical Rod of Synthesis to 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 (DMFs)

• Behave Ethically:
  Understand ethical behavior and business practices and ensure that 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.

• Solid organic chemist with strong process development skills.
• Willing to acquire and utilize advanced manufacturing to create world class commercial API manufacturing processes.
• Experience validation, DMF support and commercial technical transfers is preferred.
• Work well with other disciplines (safety, analytical chemists, engineers, and regulatory affairs).
• Track record of high performance in process development from lab to pilot plant and into commercialization, preferably including APIs.
• Experience with successful validation of API chemical processes and support of DMF submissions.
• Broad organic chemistry knowledge base and understanding of chemical transformations.
• Experience with 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 process analytical technology.
• Ability to work effectively as an individual, within a team and with internal and external partners.
• 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.

St. Louis, MO. Hybrid position.