Process Science Manager

Menlo Park, CA 94025

Posted: 11/06/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16713

Job Description

Process Science Manager
Menlo Park, CA

Position: Manager (Upstream)

 

Key Accountabilities/Core Job Responsibilities:

• • Evaluate process with the goal of optimizing and characterizing the existing AAV process to enhance robustness, scale-ability, and/or yield,

• • Utilize design of experiment (DoE) methodology with statistical analysis to characterize the process,

• • Develop scale-down models for each unit operation to support process characterization,

• • Scale-up our platform processes from small-scale to large-scale systems,

• • Author, review, and approve technical documentation including protocols, reports, tech transfer protocols, campaign summaries, and risk assessments,

• • Lead cross-functional projects while following appropriate laboratory procedures and produce competent and reproducible results to a high technical standard,

• • Appropriately analyze data, interpret and present results to cross functional teams, and maintain accurate records with little to no supervision,

• • Independently solve complex technical problems of limited scope,

• • Oversee process development activities at CDMOs including designing studies, Person in Plant, reviewing results, and writing technical reports,

• • Technical involvement in the planning and manufacturing of AAV based viral vectors for development use encompassing the entire process from thaw to harvest,

• • Routinely mentor junior associates on scientific background and technical aspects of work,

• • Manage, motivate, and coach multiple direct reports,

 

Position Requirements and Experience:

 

• • MS with 4+ years of experience or BS with 10+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields,

• • Broad experience in cGMP biologics manufacturing and documentation, with additional understanding of regulatory guidelines is preferred,

• • Highly motivated team player capable of leading by example and who exceeds expectations in all aspects of the role,

• • Must have a deep knowledge of engineering principles applicable to cell culture process equipment and bioreactor operations,

• • Prior experience with late stage process characterization is preferred,

• • Previous managerial experience is a required,

• • Hands on experience with bioreactors at small/pilot/large scale is required,

• • Drafting study protocols and reports is required,

• • Experience using DoE software is required,

• • Must have excellent time management skills and the ability to multitask/prioritize work in order to support organizational needs, meet deadlines and timeframes,

• • Some travel is required to support process development activities at CDMOs,

 

WORKING CONDITIONS:

• • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. Walk and lift up to 10 pounds.

• • WORK ENVIRONMENT: The noise level in the work environment is usually moderate.

 

Position Type/Expected Hours of Work: This is a salaried regular full-time position. General work schedule Monday through Friday, 8: 30 a.m. to 5 p.m. As an exempt employee you may be required to work additional hours as necessary.

Meet Your Recruiter

Ashley Lee

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