Process Development Engineer III, Downstream - Drug product and Formulation

Menlo Park, CA 94025

Posted: 01/09/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16947

Job Description


1/9 - This can go up to a Manager level if we find someone that has more experience than a level III Engineer. 

Must Haves:

Looking for strong background in  drug product and formulation experience. Pretty sure we identified several of these type of candidates last year, hoping these folks are in our network. 

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

Good documentation practices, expert in purification experience (TFF & Chromatography), aseptic techniques, pipetting, cGMP experience, ELISA, qPCR, analytical methods

CMO interactions, vendor management, interactions with QA for deviations, CAPA, and drafting SOPs, batch records, and tech reports, scale-up and -down experience

 

Process Development Engineer III, Downstream - Drug product and Formulation

Menlo Park, CA (relocating to Redwood City in early 2020)

 

RESPONSIBILITIES:
  • Independently design, develop, and evaluate process changes and new technologies to optimize the existing downstream AAV process to enhance robustness, scale-ability, and/or yield.
  • Technical lead and perform the development and qualification of scale-down / up models of the platform process.
  • Technical involvement in the planning and manufacturing of AAV based viral vectors for development use encompassing the entire process from thaw to final formulation,
  • Author and review technical documentation including batch records, Tech Transfer protocols, Campaign Summaries, and risk assessments.
  • Lead and provide technical feedback during group discussions on downstream planning, processes, and projects to maintain timelines and managing project teams to meet goals.
  • Independently analyze and interpret data, draft technical summary reports, and present results to cross functional teams
  • Identify assays needed for in-process control to support Process Development Independently solves complex technical problems.
  • Follow good documentation practices to maintain accurate records through a highly organized lab notebook and data logging of process data.
  • Independently identify and solve complex technical problems of limited scope while notifying management.
  • Search literature for methods, processes, and new technologies for downstream AAV process.
  • Emphasis of Quality Control, Quality Assurance, and Consistency throughout lab work performed.
  • Collaborate and interact with R&D, Assay Development, Quality, and Pre-Clinical groups to provide support on as-needed basis.
  • Provide support for external manufacturing by reviewing and approving batch records, performing tech transfers, and providing technical support and PIP on as-needed basis,
  • Represent company to third parties (CMOs, vendors, collaborators, trade shows, training, etc.) in a professional manner.

POSITION REQUIREMENTS AND EXPERIENCE:
  • MS with 4+ years of experience or BS with 6+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields.
  • Strong background in  drug product and formulation
  • Hands on experience with TFF (Hollow Fiber / Cassettes) UF/DF, and/or GE AKTA (Avant, Pilot), chromatography at small/pilot/large scale is required. Additional experience with fill / finish is a plus.
  • Understanding of theory of chromatography, protein purification, and TFF is required.
  • Proficient in general molecular biology techniques and assays including qPCR, SS, ELISA, HPLC, and/or Mass Spectrometry.
  • Must have excellent time management skills  and the ability  to multitaskprioritize work  in order to support organizational needs, meet deadlines and timeframes.
  • Experience drafting, reviewing and following, SOPs, Batch records, technology transfer documents and protocols is required.
  • Broad experience in cGMP biologics manufacturing and documentation required, with additional understanding of regulatory guidelines preferred.
  • Highly motivated team player capable of working with others in a fast pace environment.
  • Ability to use Microsoft Excel, Word, PowerPoint. Experimental design software, and statistical data analysis software a required.
  • Prior experience with insect cell-baculovirus expression technology and AAV gene therapy is a plus.
  • Some travel is required to qualify new vendors and oversee manufacturing activities.

Meet Your Recruiter

Jesse Ashworth

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