API Innovation Center · 2 days ago
Process Engineer
St Louis, MO
Full-time
Onsite
Senior Level
5+ years expAPI Innovation Center is a non-profit organization focused on ensuring a stable U.S.-based supply of active pharmaceutical ingredients. They are seeking a talented Process Engineer to develop novel synthesis routes, lead technology development, and collaborate across various functions to optimize manufacturing processes.
ManufacturingNon ProfitPharmaceutical
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
Assists in the creation and submission of Drug Master Files (DMFs)
Qualification
Required
Bachelor's degree or higher in Chemical Engineering, Chemistry, or a related field, or equivalent experience
A minimum of 5 years overall experience with >3 years of small-molecule API manufacturing/scale-up experience
Understand bench chemistry with strong understanding of reaction mechanisms, impurity control, and downstream purification unit operations
Solid grasp of cGMP, data integrity, and regulatory expectations; strong technical writing
Work well with other disciplines (safety, process chemists, engineers, and regulatory affairs)
Experience with FDA Q7A Good Manufacturing Practice Guidance for APIs
Good mechanical aptitude
Solid understanding of analytical instrumentation and techniques as well as Process Analytical Technology (PAT)
Benefits
Competitive salary and comprehensive benefits package.
Professional development and significant opportunities for career growth.
Collaborative, passionate, and innovative team environment.
Company
API Innovation Center
API Innovation Center is a non-profit organization focuses on delivering market-competitive commercial supply of US-made APIs.
11-50 employees
H1B Sponsorship
API Innovation Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
Funding
Current Stage
Early StageTotal Funding
$38.45MKey Investors
U.S. Department of Health & Human ServicesMissouri Technology Corporation
2024-09-12Grant· $14M
2023-03-02Grant· $9.45M
2022-07-14Grant· $15M
Leadership Team
Kevin Webb
Chief Operating Officer
Recent News
2025-11-11
2025-11-04
Company data provided by crunchbase