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17 days old

Upstream Engineer II/III

Kelly Services
Durham, NC 27722
**We are Kelly Science and Clinical** **,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a growing, award-winning biopharmaceutical contract development and manufacturing organization providing fully integrated, drug development and biopharmaceutical services to pharmaceutical and biotechnology companies globally.


**Job Title:** **Upstream, Manufacturing Science, & Technology, (MS&T) Engineer, II/III**


**Overview:**


Built upon a foundation of world-class analytical capabilities, our client delivers efficient process development, clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Urgently seeking an Upstream, (MS&T) Engineer, II/III to apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into **this fast-growing, team-based, collaborative** cGMP manufacturing facility.


**Responsibilities may include (but are not limited to) the following:**


+ Lead technical transfer projects for platform and/or repeat early-mid stage clinical manufacturing programs

+ Lead technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection.

+ Support and/or drive business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicate recommendations to the client

+ Perform facility fit activities including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications

+ Provide supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs

+ Compile/analyze process data and communicating out to the client and upper management via production updates and campaign summary reports

+ Support/lead complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation

+ Support/lead collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports

+ Lead technical deviation investigations and collaborate with Operations, Technical and Quality Management to determine event impact, perform root-cause analysis and corrective action identification

+ Determine equipment sizing, media and solution preparation methods and volumes, and assist in coordinating with vendor. **Education/Experience Requirements/Competencies** **:**


+ Legally authorized to work in the job posting Country.

+ BS in Science or Engineering with minimum of 4 years industry experience, Masters with 2 years industry experience **OR** PhD with no years industry experience.

+ Expertise in upstream processing techniques and equipment in biologics

+ Experience with technical transfer and scale up is required

+ Experience with GMP compliance requirements

+ Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production.

+ Experience working in a cGMP manufacturing environment is preferred.


**Generous Compensation and Benefits Package Including Relocation Assistance**


**EOE, including Disability/Vets**


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-06 Expires: 2021-10-07

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Upstream Engineer II/III

Kelly Services
Durham, NC 27722

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