Director, Pharmaceutical Manufacturing

  • Brisbane, CA
  • Posted 13 hours ago | Updated 1 hour ago

Overview

On Site
$90 - $98 per hour
Contract - W2

Skills

Director
Pharmaceutical Manufacturing

Job Details




A pharma company in California is actively seeking an experienced professional to join their team as their new Director, CMC Pharmaceutical Manufacturing.


Responsibilities:



  • Manage/lead external drug product manufacturing of small molecules in a cGMP environment

  • Manage/lead production planning, execution, and tracking

  • Manage CMO relationships and foster collaborative partnerships. Lead and/or contribute to CMO selection and onboarding

  • Support and/or lead CMC projects of Ultragenyx s small molecule portfolio

  • Be an integral part of cross-functional and cross-discipline CMC teams for products that include synthetic components

  • Develop and maintain CMC manufacturing activities, Product Design History File and Quality Risk Management Plan

  • Manage process development and optimization technology transfer as well as production related change controls, deviations, and complaints

  • Drive RFPs, SOWs, MSAs, and other governance documents

  • Promote and implement knowledge management processes for appropriate sharing and storage of documentation

  • Provide representation on global projects and in functional and cross-functional teams


Qualifications:



  • 10+ years or more of relevant experience in small and/or large Biopharmaceutical companies and working in global organizations

  • Ph.D. or equivalent work experience in Pharmaceutical or Engineering Sciences

  • Demonstrated experience with participation in and/or leading CMC teams and executing CMC activities

  • Experience in development and clinical manufacturing of small molecule formulations and manufacturing of drug products

  • Experience in QbD, DoE, process optimization and qualification/validation, phase-appropriate manufacturing controls, up-to-date with new mfg technologies including PAT

  • Familiarity with current regulatory landscape for small molecule DPs

  • Working knowledge of quality and regulatory requirements of small molecule products, including ICH guidelines


Desired Skills:



  • Experience in formulation of multiple dosage forms

  • Knowledge of Antisense Oligonucleotide products

  • Experience with Analytical Development and Quality


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