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Kelly Services Project Manager in Cambridge, Massachusetts

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

Title: Engineering Project Manager

Location: Gaithersburg, MD / Remote

Duration: 6 – 12 months Overview

  • 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.

  • 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

Responsibilities

  • 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 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.

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.

  • B.S with 10+ years of experience

  • M.S. with 6+ years of experience

  • PhD with 4+ years of experience

  • Understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements

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.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone ( taryn.carbone@kellyservices.com ) for immediate consideration.

Why Kelly ® ?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 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.

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