Senior Process Development Engineer jobs in United States
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Kelly Science, Engineering, Technology & Telecom · 20 hours ago

Senior Process Development Engineer

Kelly Science, Engineering, Technology & Telecom is seeking a highly experienced Senior Process Development Engineer with expertise in pharmaceutical API manufacturing. This role focuses on the scale-up of processes from R&D to commercial production, including multi-kilogram batch sizes and validation activities.

Staffing & Recruiting

Responsibilities

Lead scale-up activities for API chemical synthesis from lab scale to pilot and commercial production
Develop, author, and execute batch records, protocols, and validation documents for commercial manufacturing
Collaborate cross-functionally with manufacturing, QA/QC, and other departments to ensure seamless process implementation
Mentor and lead a team of engineers, including junior staff, providing technical guidance and support
Drive continuous improvement initiatives to optimize yields, throughput, and process robustness
Ensure compliance with regulatory standards such as cGMP, ISO, and FDA guidelines

Qualification

Pharmaceutical API manufacturingProcess optimizationTechnology transferAnalytical instrumentationCGMP complianceTeam leadershipCommunication

Required

Minimum 10 years of experience in pharmaceutical API manufacturing, specifically chemical synthesis
Hands-on experience with scale-up from R&D to commercial production batches (multi-kilogram scale)
Strong knowledge of process development, technology transfer, and reaction calorimetry
Proficiency with analytical instrumentation (e.g., HPLC, GC, NMR, TGA, DSC) is highly desirable
Experience writing and managing validation and batch records in a regulated environment
Ability to lead and mentor engineering teams effectively
Excellent communication skills and ability to work cross-functionally

Benefits

Medical
Dental
Vision
Telemedicine
Term life
Whole life
Accident insurance
Critical illness
A legal plan
Short-term disability
Retirement savings plan
Service bonus
Holiday pay plans (earn up to eight paid holidays per benefit year)
Transit spending account
Paid sick leave under the applicable state or local plan

Company

Kelly Science, Engineering, Technology & Telecom

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Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.

Funding

Current Stage
Late Stage

Leadership Team

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Linda Stuit
Senior Vice President, Engineering Specialty
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Company data provided by crunchbase