1+ months

Biologics Process Engineer (MSAT) - Downstream, San Diego, CA

Kelly Services
San Diego, CA 92108
**Sr. Biologics Process Engineer (MSAT) - Downstream, San Diego, CA**

**Overall Responsibilities:**

Manufacturing Science and Technology (MSAT) is a partner of biologics manufacturing operations and is the custodian of manufacturing processes with strong collaboration from Process Development group. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved. Our CDMO is currently seeking a Sr. Biologics Process Engineer to join the Downstream MSAT to lead and support the planning and execution of cGMP clinical phase manufacturing operations.

**Position Responsibilities:**

+ Recommend strategies for improving purification procedures for top performance using bioprocess engineering principles and protein biochemistry.

+ Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.

+ Network with Process Development, Manufacturing, and Quality organizations to establish a reliable state of process control.

+ Actively lead technical transfer and implementation of purification processes including facility fit modeling based on client needs.

+ Actively participate in process validation activities.

+ Build, modify, and utilize digital data storage, visualization, and analysis systems such as Minitab and/or JMP and custom web-based interfaces to enable site process monitoring and continuous process verification programs.

+ Generate documents (technical memos, protocols, reports) related to process monitoring, product impact assessments, campaign end summary reports.

+ Provides training as needed and ensures adherence to company policies and quality requirements.

+ Currently in the process of building a state-of-the-art biologics manufacturing facility heavily leveraging disposable technology. The candidate will have the opportunity to support multiple manufacturing commissioning projects.

**Qualifications/Skills Required:**

+ Bachelor's degree (BS) in Chemical Engineering, Biochemistry, or equivalent with 5-10 years of relevant downstream processing experience.

+ Working knowledge of protein purification techniques involving chromatographic and filtrationbased technologies.

+ Well-experienced with operations of AKTA Pilot, AKTA-Ready, Flex-ACT, Starto-Flow and other disposable downstream skids.

+ Detailed knowledge in creation of process methods/recipes using GE unicorn software.

+ Strong knowledge of MS Office including Excel, PowerPoint, and Word.

+ Must have experience within biologics CMC that includes pilot plant and/or cGMP manufacturing.

+ Must have experience in technology transfer from development into a cGMP Manufacturing.

+ Must be able to demonstrate significant success in technical proficiency, scientific creativity, and collaboration with others.

+ Must be able to clearly communicate scientific information both written and oral.

+ Ability to present technical information to both technical and non-technical audiences is required.

+ Must be able to demonstrate sound judgment and problem-solving capabilities with exceptional interpersonal skills.

+ Strong organizational skills are required.

+ Project management experience is a plus.

**For immediate consideration apply today?**

**Questions? Please reach out to Dustin at**

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

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**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. at
Posted: 2019-12-13 Expires: 2020-02-24

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Biologics Process Engineer (MSAT) - Downstream, San Diego, CA

Kelly Services
San Diego, CA 92108

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