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2C
22nd Century Technologies, Inc
Scientist Vpp Downstream Group /Principal VPP Scientist - HYBRID
Career Insights for Process Development Engineer
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What they do
A Process Development Engineer designs and implements production systems in manufacturing, engineering or mining. Develops processes that are efficient and cost effective. Plans, implements and tests production systems and processes and ensures compliance with industry and regulatory standards.
$117,822 / year median in Maryland
+3% projected growth
Job Description
Education Master's degree in Biochemical Sciences or related field PhD in Bioengineering, Chemical Engineering, Biochemistry, or related discipline required Experience 8+ years in recombinant protein purification for GMP clinical-phase products Experience with downstream process development and technology transfer Experience supporting IND submissions and regulatory documentation Experience in viral clearance strategy and validation Experience mentoring scientists and leading technical projects Required Skills Strong knowledge of downstream process development Expertise in protein purification and process optimization Familiarity with DOE using JMP Strong documentation and record-keeping skills Excellent verbal and written communication Ability to work in cross-functional teams Proficient with Microsoft Office and data analysis software Job Responsibilities Lead downstream process development for clinical candidates Oversee technology transfer to manufacturing teams Develop and optimize purification processes Support GMP clinical material production Lead viral clearance strategy and validation activities Support IND submissions and regulatory requests Review and approve process protocols and reports Troubleshoot downstream manufacturing processes Train staff on laboratory equipment and techniques Maintain laboratory equipment and research facilities Coordinate with manufacturing and project teams Analyze research data and prepare technical reports Present research at scientific meetings and conferences Publish research findings in peer-reviewed journals Serve as SME for purification strategies and process development Mentor junior scientists and support project milestones Deliverables Present project and laboratory updates as required Ensure timely completion of downstream development milestones Support successful production and technology transfer activities AL_TSC About our