CenterWatch

1+ months

Senior Associate 2 - Biologic Technical Operations, Purification, Oceanside, CA

Kelly Services
Oceanside, CA 92054
**Senior Associate 2 - Biologic Technical Operations, Purification, Oceanside, CA**



Exciting opportunity for an experienced candidate in Biologics Technical and Manufacturing Operations at one of our top clients' Oceanside facility!



We are seeking motivated, team oriented individuals with expertise in purification operations and technical transfer of recombinant proteins. Reporting to the Director of Technical Operations, you will have the opportunity to participate in technology transfer of monoclonal antibody purification processes to internal and external manufacturing sites



**Schedule/Shift:** M-F; 1st; 8AM-5PM



**Job Duties and Responsibilities:**




+ Support biologics purification technical operations by enabling timely and successful technology transfer of downstream manufacturing processes to external partners (CMOs)

+ Perform facility fit assessments and identify process gaps and generate solutions to ensure successful process fit into internal and external manufacturing plants

+ Collaborate with the Process Development, Manufacturing, and Upstream Technical Operations to ensure successful technology transfer of biologic processes including evaluation of the automation and process control strategy, bill of materials, and master batch record drafting/review

+ Monitor and evaluate purification process performance data, report and present findings

+ Support and drive yield improvements and process efficiencies

+ Lead/coordinate cross-functional projects with limited direction

+ Independently plan and execute experiments in a pilot or laboratory setting in support of process optimization initiatives or manufacturing technical assessments

+ Apply knowledge of current Good Manufacturing Practices (cGMPs)

+ Contribute to and/or lead technical investigations of process deviations and assessment of impact on product quality

+ Identify areas for improvement or optimization, lead implementation of best practices, and present data to applicable departments on the outcome of investigations or optimization initiatives

+ Coordinate or support implementation of new technologies onsite and at CMOs.

+ Serve as a subject matter expert during purification operations; provide technical troubleshooting and investigative support during internal and external manufacturing runs.

+ Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)

+ Demonstrates excellent verbal, written and interpersonal communication

+ Works on non-routine to somewhat complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action



**Job Requirements:**




+ Bachelor's degree (BS) in Chemical / Biochemical Engineering, Biochemistry, Biology or a related scientific discipline and five (5) years of relevant, industry experience, OR

+ Master's degree (MS) in Chemical / Biochemical Engineering, Biochemistry, Biology or a related scientific discipline and three (3) years of relevant, industry experience

+ Prior experience in a Technical Operations / MSAT purification role including technology transfer of biologics to contract manufacturing sites

+ Knowledge of cGMPs and validation requirements in all clinical phases

+ Antibody experience is required. Familiarity with monoclonal antibody downstream platforms, centrifugation, chromatography, and filtration. Biologics experience with alternative modalities, expression systems, antibody design variants, and/or cell therapy is a plus

+ Must be able to work effectively in cross-functional teams

+ Must demonstrate excellent technical writing skills



**Skills:**




+ Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)

+ Demonstrates excellent verbal, written and interpersonal communication

+ Works on non-routine to somewhat complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action

+ Support biologics purification technical operations by enabling timely and successful technology transfer of downstream manufacturing processes to external partners (CMOs)

+ Perform facility fit assessments and identify process gaps and generate solutions to ensure successful process fit into internal and external manufacturing plants

+ Collaborate with the Process Development, Manufacturing, and Upstream Technical Operations to ensure successful technology transfer of biologic processes including evaluation of the automation and process control strategy, bill of materials, and master batch record drafting/review

+ Monitor and evaluate purification process performance data, report and present findings

+ Support and drive yield improvements and process efficiencies

+ Lead/coordinate cross-functional projects with limited direction

+ Independently plan and execute experiments in a pilot or laboratory setting in support of process optimization initiatives or manufacturing technical assessments

+ Apply knowledge of current Good Manufacturing Practices (cGMPs)

+ Contribute to and/or lead technical investigations of process deviations and assessment of impact on product quality

+ Identify areas for improvement or optimization, lead implementation of best practices, and present data to applicable departments on the outcome of investigations or optimization initiatives

+ Coordinate or support implementation of new technologies onsite and at CMOs.

+ Serve as a subject matter expert during purification operations; provide technical troubleshooting and investigative support during internal and external manufacturing runs



**For immediate consideration, apply today! Questions? Call Grace at 714.971.0721 or Email at grace.piper@kellyscientific.com**






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



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000
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.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2018-12-17 Expires: 2019-02-18

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Senior Associate 2 - Biologic Technical Operations, Purification, Oceanside, CA

Kelly Services
Oceanside, CA 92054

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