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Quality Product Leader - Vaccine

Location: San Diego, CA, United States
Job # 11056667
Date Posted: 06-14-2018
Quality Product Leader - Vaccine
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert or Extend)
Full time: Mon – Fri: 8am – 5pm
Pay: Depends on Experience
Start Date: ASAP
 
Client Overview:
Our client is a clinical late-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. We have the highest-quality protein production and bioanalytic technology platform approach that allows us to create biosimilars in a highly efficient manner from concept to commercialization.

Job Description:
The Quality Product Leader will work in partnership with the Product Development Leader to execute a quality strategy and provide quality operations support to all business processes. In this role, the Quality Product Leader will be responsible for assuring consistency in achieving product quality and compliance across multiple sites (drug substances, drug product, devices/combination products). As the Product Quality Leader, you'll be expected to be familiar with all area of product development and QA commercialization activities.

Responsibilities:
  • Assures product quality through the lifecycle of the product
  • Ability to communicate, influence and motivate teams to reach quality objectives
  • Assures supplier audits for key raw materials and components
  • Facilitate / approve Change Control (process/methods) and impact, as appropriate
  • Serves as the single-point-of-contact to Product Development Tea
  • Provides functional area technical expertise to Product Development Team
  • Participate in Regulatory strategy design; data verification, supplemental/variances, renewals, CMC Maintenance, APR
  • Assures Quality Agreements for any contract and co-manufacturing/testing is executed according to project timelines
  • Involved with testing strategy in partnership with analytical team
  • Provide support on method transfer
  • Review / approve master batch records
  • Involved/ review Quality Target Profile, and CQA's
  • Knowledgeable in Quality Systems and industry standards (cGMP, ICH guidelines, PFEnex Policies, procedures, and Supply and Quality Agreements
  • Expected to demonstrate PFEnex Values; Trust, Integrity, Accountability, Ambition, and Innovation
  • Develop an integrated Global Quality plan considered product life cycle management, contingency and sourcing decisions
  • Responsible for quality related milestones; new product with risk assessments, CQA, CPP, Design space and control strategy prior to transfer into production
Experience:
  • 10+ years of biosimilar and/or pharmaceutical process development/ characterization, and/ or clinical/ commercial manufacturing experience required
  • 5+ years of cGMP/ GLP environments and regulations experience required. (large molecules)
  • 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
  • Possesses and demonstrates exceptional problem solving skills
  • Proven ability to work in a lean organization and creatively tackle problems
  • Work independently in a matrix environment and manage multiple tasks simultaneously
  • Experience with biopharmaceutical Quality product research, clinical, and commercial manufacturing
  • Significant experience with MS Office Suite; Project, Visio, LIMS, and EDMS
  • Working knowledge of U.S. Government-funded programs is preferred
  • Other skills and abilities as required
Supplemental Experience as a Strong Plus
  • Experience working in a drug-development organization; biosimilars development preferred
  • Experience in a publicly traded biotech/pharma/scientific-related company preferred
  • Experience working in a start-up or fast-growing company preferred
Education
  • BA/BS degree in life sciences, engineering or a related discipline required
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