Early Stage Process Development Upstream Engineer III

Menlo Park, CA 94025

Posted: 09/30/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16496

Job Description

Early Stage Process Development Upstream Engineer III
Menlo Park/Redwood City, CA

We are currently  looking to bring onboard an upstream Process Development Engineer III to help lead the continued development, characterization and manufacturing of novel AAV vectors for both our rare disease and ophthalmology programs.

RESPONSIBILITIES:
  • Identify and evaluate process changes with the goal of optimizing the existing AAV manufacturing process to enhance robustness, scale-ability, and/or yield
  • Design and implement upstream bioreactor process scale-up efforts across 3L, 50L and 200L vessels, including but not limited to kLa, transfection optimization, lysis and filtration studies
  • Technical involvement in the planning and manufacturing of AAV based viral vectors for development use encompassing cell thaw to harvest and filtration
  • Author and review technical documentation including batch records, developability assessments, method development reports and process history summaries
  • Follow 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 no supervision
  • Ensure safe workplace in compliance with the company and EHS rules and regulations
  • Independently solves complex technical problems of ranging scope
  • Works collaboratively and diligently with own group and broader cross functional team(s) to achieve shared objectives
  • Coordinate and manage day to day activities in the lab in order to adhere to the company’ s timelines and goals
  • Routinely mentor junior associates on scientific background and technical aspects of work

POSITION REQUIREMENTS AND EXPERIENCE:
  • MS with 4+ years of industry experience or BS with 7+ years of industry experience with a Biochemical or Chemical Engineering degree
  • Hands on experience with stir-tank bioreactor process scale-up in an industry setting is required
  • Direct experience utilizing DOE software (JMP, DesignExpert) is required
  • Experience drafting SOPs, Batch records, reports, and protocols is required
  • Preference given to candidates with knowledge of PAT and data management systems
  • Proficient in general molecular biology techniques including Western Blot, qPCR, BCA
  • Highly motivated team player with excellent verbal and written communication skills, who is capable of leading by example and exceeds expectations in all aspects of the role
  • People management and/or leadership experience is a plus

 

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Marissa Kochan

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