27 days old

Process Development Manager

Kelly Services
Gaithersburg, MD 20898
Kelly has a great opportunity as a Process Development Manager in Gaithersburg MD!

You will support the development and tech transfer of processes to manufacture purified Lentiviral vectors used for pre-clinical and clinical products.

Additional responsibilities:

+ Manage the Upstream PD team and oversee activities relevant to manufacturing of viral vector for pre-clinical and tech transfer purposes as well as planning and leading upstream studies in support of process improvement, process characterization, and tech transfer.

+ Prepare documentation in support of development, tech-transfer, and pre-clinical production

+ Lead scientific/technical activities to design, optimize and characterize upstream process based on quality by design (QbD) principles; Identify Critical Process Parameters and perform studies to better understand their influence on Critical Quality Attributes; Execute and analyze DOEs (i.e. characterization studies) using JMP statistical analysis software.

Requirements include:

+ Bachelors Degree in the life sciences with at least 5-8 years of relevant experience; or equivalent combination of education and experience.

+ Leadership experience with demonstrated proficiency in effectively managing a team.

+ Subject-matter-expert level of knowledge in mammalian cell culture, bioreactor operation and control, and scale-down model development. Lentiviral vector experience preferred.

+ Experience with analytical methods common to production and characterization of viral vectors (i.e. ELISA, qPCR, Cell transduction, Flow Cytometry, SDS-PAGE, HPLC, etc.).

+ Experience using molecular biology software to analyze plasmid DNA constructs (i.e. Clone manager).

+ Knowledgeable in cGMPs and Regulatory guidance (ICH, FDA, EMA, PDA, etc.)

Please apply now!

**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. (
Posted: 2021-08-23 Expires: 2021-09-23

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Process Development Manager

Kelly Services
Gaithersburg, MD 20898

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