Associate Director, Manufacturing Sciences and Technology (MSAT)

Salary depends on experience
Posted on 11/02/17
San Francisco, CA
11 - 15 years experience
Patient Care
Salary depends on experience
Posted on 11/02/17

Description

The Associate Director, Manufacturing Sciences and Technology (Purification), will be a primary technical liaison for manufacturing of Portola's lead recombinant protein biologic produced in Chinese hamster ovary (CHO) cells at Contract Manufacturing Organizations (CMOs). The successful candidate will play a lead role in the Continued Process Verification program. In addition, this person will lead studies on process improvements, technology transfers, scale up and trouble-shooting of process-related issues, and will drive root cause analysis of manufacturing deviations. This person will ensure project-related timelines are met working with Portola's CMOs. Internally, the Associate Director will work closely with R&D in evaluating Andexanet alfa process robustness and productivity and will lead the Andexanet alfa Downstream Working Group.

 Responsibilities:

  • Participates in preparation, review and approval of CMC sections of regulatory filings and acts as process design SME during regulatory inspections.
  • Reviews and approves MBRs
  • Interfaces with Quality and leads studies to support root cause analysis, product impact assessments and closure of manufacturing process deviations
  • Troubleshoots process-related issues (due to deviations, out-of-trend performance, etc.) and facilitates corrective actions working with CMOs
  • Ensures that all process characterization, technology transfer and scale-up studies are executed by CMOs in accordance with documented work orders and approved protocols
  • Reviews and approves scientific protocols and reports from the CMOs for studies ensuring content is appropriate for Portola's Regulatory filings
  • Performs Manufacturing data trending real-time
  • Supports late stage development activities including PPQ planning, execution and PAl preparations, and plays a lead role in Continued Process Verification program
  • As a member of the Manufacturing sub teams, assists in development and execution of project plans and schedules that represent the appropriate level of detail and have accurate resource planning estimates to support process development and team objectives
  • Keeps management informed of any significant risks to CMC timelines and/or budgets
  • May serve as Person-In-Plant (PIP) providing Portola technical oversight of CMO manufacturing activities and provides on-site oversight at CMO's during critical activities

Requirements:

  • BSc, MSc or PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 12 years for BSc or MSc or 8 years for a PhD of relevant experience in the bio/pharmaceutical industry in Process Development, MSAT or Manufacturing environment
  • SME in Downstream Process Development, Scale-up and Process Characterization of recombinant biologics; cell line and upstream development experience a plus
  • Good understanding of FDA/EMEA/ICH/cGMP guidance documents
  • Strong working knowledge of current Regulatory guidance on late stage and continued process verification requirements is a plus
  • Moderate project management skills
  • Prior experience working with and managing CMO activities
  • Prior experience writing CMC sections of regulatory submissions is a plus
  • Able to thrive in a small group setting with limited administrative support
  • Up to 20% travel required

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