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19 days old

Biologics Drug Substance/Drug Product Technology Transfer Lead

Kelly Services
Gaithersburg, MD 20898
**Kelly Services** has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract temporary opportunity to work as a **Biologics Drug Substance/Drug Product Technology Transfer Lead (multiple positions)** at a prestigious Fortune 500 company in **Gaithersburg, MD**



**Job Length: 6 months**



**Pay rate: Up to $90/hour**



USP/DSP TT Lead (New and reports to DS TT Lead)

o B.S with 6+ years of experience

o M.S. with 4+ years of experience

o PhD with 4+ years of experience


**Biologics Drug Substance/Drug Product Technology Transfer Engineer**


Position Description:

AstraZeneca (AZ) is developing a vaccine to target Covid-19. As part of this effort, the Biologics Global Technical Operations (GTO) group is working with AZ 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.


We are 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 AstraZeneca 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 AZs 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 AZ 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 AZ 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.


**Minimum Requirements:**

Education/Experience

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.

o B.S with 10+ years of experience

o M.S. with 6+ years of experience

o PhD with 4+ years of experience


**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



**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 resumes. Thank you for your interest in the assignment.








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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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. 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.

\#KellyGTS
Posted: 2020-10-05 Expires: 2020-11-07

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Biologics Drug Substance/Drug Product Technology Transfer Lead

Kelly Services
Gaithersburg, MD 20898

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