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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

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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
Company:
- 22nd Century Technologies Inc., (TSCTI) is one the fastest growing healthcare staffing companies in the United States. With presence in all 50 States and 6000+ employees nationwide, we have been providing unparallel healthcare and technology staffing services to Public and Private sectors for over 26 years. Started as a technology staffing company in 1997, we have significantly expanded our healthcare practice to both Clinical and Non-Clinical staffing, serving various facilities, healthcare organizations and government agencies. Our ISO certified staffing practices and technology driven staffing procedures - from recruitment to onboarding, along with an internal pre-vetted resume database of healthcare professionals, enable us to serve our customers with their immediate staffing needs. TSCTI has extensive experience providing Physicians, Nurses, Pharmacists and other Allied Health professionals to various states - California, Connecticut, District of Columbia, Florida, Michigan, Minnesota, New Jersey, New York, Texas, Vermont, Virginia to name a few, and Our valued relationships with employees as well as commitment to meet and exceed clients' expectations through our exemplary employees proves our competency in today's healthcare staffing industry. Recognized among "Best Company to Work For" by Forbes, 22nd Century Technologies, Inc., consistently exceeds our clients' expectations by focusing on their absolute satisfaction with jobs while keeping our employees motivated. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Pay:
$80,000.00 - $140,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Vision insurance
Education:
Doctorate (Required)
Experience:
GMP protein purification: 8 years (Required) downstream process development: 8 years (Required) viral clearance validation: 5 years (Required) Ability to
Commute:
Bethesda, MD 20814 (Required)
Work Location:
In person