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30 days old

Biologics Drug Substance/Drug Product Technology Transfer Engineer

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Biologics Drug Substance/Drug Product Technology Transfer Engineer in Gaithersburg, MD to work a contract assignment of 6-12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities of the** Biologics Drug Substance/Drug Product Technology Transfer Engineer **includes:**



The client is developing a vaccine to target Covid-19. As part of this effort, the Biologics Global Technical Operations (GTO) group is working with colleagues in R&D to enable the technology transfer of the drug substance (DS) and drug product (DP) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process qualification and commercial manufacture.


Looking to augment the GTO team working on technology transfers with a DS / DP Tech Transfer Engineer. In this role, you will also work with GTO Drug Substance and/or Drug Product technical stewards, R&D process development and quality experts within the company and partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO. You will be expected to stay on the program for a minimum of 6 months and up to 12 months.




+ To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements.

+ The position provides the opportunity to work with a highly motivated and talented global team, working under aggressive timelines to deliver a cutting edge monoclonal antibody manufacturing process to multiple world-class manufacturing facilities and support the companys efforts in dealing with the Covid-19 pandemic.



Essential Job Functions:




+ Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with the company and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.

+ Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.

+ Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.

+ Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.

+ Work with CMOs to compile and trend DS/DP manufacturing process data during manufacturing campaigns.

+ Note: The team will be based in the US East Coast, CMOs receiving technology transfers are located in EU, and Far East. Will require ability to work flexible hours to support multiple global time zones.



Knowledge/Skills




+ Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.

+ Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills

+ Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations

+ Ability to work in a complex, dynamic, global environment



Education and Experience Requirement of the Biologics Drug Substance/Drug Product Technology Transfer Engineer includes:




+ Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred.

+ B.S with 10+ years of experience

+ M.S. with 6+ years of experience

+ PhD with 4+ years of experience



**Additional Information:**




+ Contract assignment, duration 6-12 months.

+ Work schedule: full-time, first shift.



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3037376]



Thank you for your interest in the assignment.




**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-19 Expires: 2020-09-19

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Biologics Drug Substance/Drug Product Technology Transfer Engineer

Kelly Services
Gaithersburg, MD 20898

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