Senior Process Chemist

Primary Duties and Responsibilities

• 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 synthesis route 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.
• Aids in the creation and submission of Drug Master Files (DMFs).

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 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 Qualifications

• 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.

Education and Experience

• 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. Hybrid position.

Application Requirements

Please apply on our website https://apicenter.org/careers/senior-process-chemist.