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Downstream Process Transfer Manager- Bothell, WA

Kelly Services

Bothell, WA 98021
Kelly Services
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Job Details

Kelly Scientific is searching for a **Downstream Process Transfer Manager** to join a growing global biologics company located in Bothell, WA. This is an exciting opportunity to provide leadership and oversight of Downstream (Purification) Process Transfer from Process Development into Manufacturing, the implementation of new technologies and systems into GMP operations, and key aspects of the start-up of new manufacturing facilities. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental relationships.

This is a direct hire position, working M-F 8am-5pm, with flexibility required and ability to be on-call as projects are timeline driven.

**Job Responsibilities** **:**

+ Lead Process Transfer activities from Process Development to Manufacturing and incorporate application of Lean and Six Sigma methodologies to drive process improvement. This includes driving the entire effort of drafting and revising process transfer documents; facility/equipment fit modeling, raw material estimates, manufacturing batch records and sample plans.

+ Serve as a key representative on project teams to identify, define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biotechnology APIs.

+ Develop standards supporting Process Transfer activities and serve as Subject Matter Expert to troubleshoot processes and equipment during investigations or cycle and process development on the manufacturing floor. Driving event and process analysis via Root Cause Analysis.

+ Lead the engineering effort to acquire process equipment from design through procurement, installation and operational readiness, and associated required GMP documentation.

+ Prepare and present data associated with manufacturing processes to internal and external clients. May serve as the escort during Person-in-Plant activities.

+ Provides mentorship, guidance, and training to downstream Process Transfer team, as well as high-level technical leadership to Manufacturing and other departments associated with GMP operations.

**Requirements** **:**

+ Bachelors or Masters Degree in engineering or science (or equivalent work experience)

+ Minimum of 10+ years experience e in biopharmaceutical manufacturing operations preferred

+ Minimum of 3+ years experience in leadership/management/supervisor in Manufacturing and/or Process Engineering, with a preference toward pharmaceutical or other regulated industries

+ Experience with bringing biotechnology equipment and processes from design through GMP operational readiness

+ Must be self-motivating, organized and proactive in order to coordinate the multi-departmental tasks and deliverables (interaction with PD, Eng., QA, QC, etc.)

+ Proven expertise in mentoring/development, change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by cross functional teams.

+ Strong knowledge in the following system(s):Pharmaceutical Utilities, Purification, Filling, Bioreactors, Automation, Sterilization, and Water Purification.Driver for process improvement/design via Lean and Six Sigma methodologies.

+ Strong technical aptitude including demonstrated experience of applying scientific reasoning to solve complex problems.

+ Ability to work hours necessary to support production and/or maintenance activities

+ Ability to lift up to 40lbs. with assistance

+ Ability to work in confined spaces and near operating equipment

+ Ability to work in loud noise environments

**Apply today!**

**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 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.
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