JOB SUMMARYThe Development Engineer III serves as an advanced individual contributor responsible for leading complex process development and scale-up activities for APIs and intermediates. This role independently drives technical solutions from laboratory through pilot and early commercial manufacturing, applying strong engineering judgment and cross-functional collaboration. This role level demonstrates deep technical capability, ownership of process strategy, and consistent contribution to commercial readiness and continuous improvement initiatives.
DUTIES AND RESPONSIBILITIES- Lead design and execution of laboratory and pilot-scale experiments for reactions, extractions, distillations, crystallizations, filtrations, and drying operations.
- Develop and reconcile scalable mass and energy balances through commercial projection; validate assumptions with plant data.
- Identify and implement process optimization strategies to improve yield, safety, robustness, and cycle time.
- Serve as technical lead for assigned projects and provide clear process recommendations to stakeholders.
- Own preparation and technical review of batch records, process descriptions, and first-scale batch documentation.
- Lead plant trials, demonstration campaigns, and first commercial batches; confirm CPPs, CQAs, and operating ranges.
- Troubleshoot scale-dependent issues and implement corrective actions during manufacturing campaigns.
- Partner with Manufacturing, Quality, EHS, and Supply Chain to ensure safe, compliant, and efficient scale-up.
- Evaluate reactive and hazardous materials, recommend mitigation strategies, and support hazard assessments (e.g., dust hazard data, reaction calorimetry).
- Collaborate on solvent selection, cleaning strategies, and waste stream optimization.
- Support environmental permitting considerations and ensure adherence to GMP and company safety standards.
- Apply Quality by Design (QbD) principles, including design of experiments (DoE), definition of CPPs, and control strategy development.
- Analyze process data to support investigations, deviations, and continuous improvement initiatives.
- Prepare technical reports, scale-up summaries, and client-facing documentation as required.
- May perform other duties as assigned.
EDUCATION AND EXPERIENCE- 6-9 years of related experience and a bachelor's degree or 4-7 years of related experience and a master's degree or 1-4 years of related experience and a PhD in a related field.
- Bachelor's degree in Chemical Engineering or related engineering discipline required.
COMPETENCIES/SKILLS- Strong command of chemical engineering principles including mass and energy balances and scale-up methodology.
- Experience leading pilot or early commercial manufacturing campaigns.
- Demonstrated ability to independently troubleshoot and resolve complex technical issues.
- Working knowledge of GMP manufacturing and regulatory expectations.
- Strong communication, documentation, and cross-functional collaboration skills.
- Proficiency in Microsoft Excel and technical data analysis tools.
WORKING CONDITIONSOn-site laboratory, office and pilot plant. Shift coverage (day, swing, night) will be periodically required. Periodically participates in production support that may include nights, weekends, and holidays.
This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role, consistent with applicable law.
