Pfenex Inc.
  • 17-Sep-2018 to 16-Nov-2018 (PST)
  • San Diego, CA, USA
  • Full Time

POSITION SUMMARY

Reporting directly to the VP Global Quality, as a key member of the Quality Organization, the Director of Quality Assurance/Quality Control (QA/QC) is responsible for Quality Assurance/Quality Control Operations (QA/QC) in support of PFEnex products. Strong QA/QC experience in biosimilar and recombinant vaccine biopharmaceutical environment from research and development to commercial. Interface closely with various departments to ensure that QA/QC related activities at PFEnex, PFEnex partners or service providers are properly managed to support process/method transfer, disposition of products, achieve project goals, and timelines. This position presents a great opportunity to be part of a team that drive the company Quality Culture and continuous improvement and support the advancement of a broad portfolio of biosimilar products and recombinant vaccines. We are interested in candidates with a proven track-record of successfully and efficiently integrating activities and perspectives across functions to achieve our ultimate goal of delivering Quality cost effective therapies that enable access to patients who need them.

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

  • Actively, support in the development of the long-term Quality strategy for Pfenex business model and overall quality oversight. Be flexible, transition from strategy to tactical activities.
  • Actively support, develop and drive Pfenex Quality Culture by embedding quality into business processes which support GCP, GLP, GMP's including suppliers, external CMO's, CRO's and Contract Laboratories.
  • Develop continuous improvement plan, establish metrics and facilitate review at Quality Operations Review
  • Provide Quality oversight to contract manufacturer/contract laboratories, identify GxP quality risks and present integrated risk management solutions to senior leadership teams.
  • Act as Person in the Plant for Pfenex CMO's, if applicable.
  • Collaborate and partner with Process Development, Analytical and Manufacturing Team, Program Management Office, Regulatory and CMC in support of product pipeline and registration activities.
  • Provide strategic leadership and coaching to direct reports in the execution of their functions. Attract, develop and lead a high performing, global and diverse team to support Pfenex
  • Direct and Approve and/or generate GxP documents, technical transfer, Specifications, Validation documents, Method Validations, Risk Assessments, Change Control, Deviations, OOS, Master Batch Records and product disposition.
  • Manage regulatory inspection or Board of Health communication and partner to support CMC related activities in Quality response preparations. Proactively lead inspections readiness program and prepare for pre-approval inspections.
  • Ensure that the in-process analytics and quality control comply with regulatory requirement
  • Generate COAs as needed for Pfenex products; oversee revisions
  • Work with analytical function to determine product release assays; review release assay data
  • Oversee Reference Standard documentation and characterization plan; determine primary and secondary references; new reference bridging plan; reference stability
  • Oversee CMO/partner QC analytical cGMP activities: review SOPs, validation protocols, validation reports, verification protocols, verification reports; method transfer protocols for validated methods; ensure data integrity
  • Other duties as assigned or required.

JOB SKILLS, ABILITIES, AND QUALIFICATIONS

A minimum of a Bachelor's of Science degree in life sciences or other relevant biologic, chemistry, biochemistry discipline required; Master's degree preferred.

  • 10+ years of Pharmaceutical/Biopharmaceutical Quality, Compliance, Quality Control experience in support of clinical/commercial manufacturing of Biologics, Sterile Fill Finish, combination products and/or device  required
  • 5+ years of managing, leading and developing others required
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required.
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality Guidelines
  • Manage Regulatory Board Inspections, FDA, EMEA, PMDA, etc.
  • ASQ, Black Belt/Green Belt certifications a plus.
  • Ability to travel up to 25% (US and Internationally)
  • Ability to work flexible work schedules.
  • Excellent computer, verbal, and written communication skills
  • Innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Proven ability to work in a lean organization and creatively tackle problems.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.
  • Experience in process characterization within biosimilars process development organization
  • Experience with biopharmaceutical product PD, research, clinical, and commercial manufacturing
  • Significant experience with MS Office Suite; Project, Visio, LIMS, and EDMS.
  • Experience with analytical process characterization techniques (HPLC, ELISA, SDS-PAGE and CE).
  • Working knowledge of U.S. Government-funded programs is preferred
  • Other skills and abilities as required

 Additional Information:

*All new hires are required to go through a background and reference check
*Affirmative Action and Equal Opportunity Employer (EOE)
*No agencies or phone calls please
*Pfenex celebrates the diversity of life and welcomes all individuals to apply
*Pfenex does not currently offer sponsorship or consideration to those on an H1-B or other similar visas at this time

 

Pfenex Inc.
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