Process Engineer

APIIC is a nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to revolutionizing pharmaceutical development through innovative chemical and semisynthetic research. Through investments and collaboration along the supply chain, APIIC’s model contracts leading U.S.

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

Our mission is to drive national health security and economic growth through U.S.

-based production of medicines so that every patient, healthcare system and pharmacy retailer has access to critical medicines.

About the Role

We are looking for a talented Process Engineer to work closely with synthetic chemists to develop novel routes of synthesis using advanced manufacturing technologies. The position will be a lead role in technology development with activities in the following areas.

• Scale-up & Tech Transfer: Convert lab procedures to scalable unit operations (reaction, crystallization, filtration, drying), author/execute transfer packages and PPQ protocols. Identify large‑scale equipment and work with third‑party vendors to design and qualify. Help troubleshoot issues with existing and new commercial equipment.
• Validation & Compliance: Lead/author process validation documents, batch records, change controls; investigate deviations/OOS and drive CAPA.
• Cross‑Functional
  
  Collaboration:
  
  Work closely with R&D/Analytical, QA/QC, Supply Chain and external customers to meet timelines and conduct DOE work to better understand CQA’s and CMS’s. Participate, lead, and conduct process risk evaluations.
• Documentation: Write SOPs, reports, and technical summaries suitable for regulatory inspections.

Primary Duties and Responsibilities

• 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 complex advanced manufacturing processes utilizing state‑of‑the‑art technology.
• Work with external subject matter experts and stay abreast of latest technologies and applicable federal regulations.
• Execute development studies to support lab‑scale and commercial API manufacturing processes.
• Provide technical leadership for transfer of a completely defined process to contract manufacturing organizations for manufacturing under cGMPs.
• Preparation and review of relevant documentation including, but not limited to, reports, specifications, and batch records, as well as updating relevant lab records.
• Assist 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 that 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 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 toward goals, and track details, data, information and activities.
• Plan: Determine strategies to move the project and organization forward, set goals, create and…