Pfenex Inc.
  • 21-May-2018 to 30-Dec-2018 (PST)
  • San Diego, CA, USA
  • Full Time

Pfenex is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value, difficult to manufacture proteins. We are committed to providing innovative solutions for global health. Our team is made up of driven, talented, motivated individuals making an immediate impact within our fast-paced dynamic organization.

POSITION SUMMARY

The Risk Management SME is responsible for supporting risk management activities for new product development and product maintenance through the application of Quality engineering skills for drugs, biologics, and medical devices. This person will support projects and tasks through the product lifecycle.  The idea candidate should have experience with PAI readiness and combination products or devices.

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

 

Primary Responsibilities

Provide Risk Management technical expertise and engineering support through the product life cycle for new product development projects and existing products.

  • Develop and implement Risk Management for Pfenex Combination Products (including risk assessment and control for material, product, process, and quality)
  • Provide guidance to teams on risk management, regulatory and quality engineering policies, principles and best practices.
  • Facilitate development and completion of risk management deliverables by collaboratively working with quality, R&D, engineering, marketing and clinical.
  • Develop and maintain Risk Management Files according to ISO 14971 and ICH Q9 and ensure Risk Management Files are updated per defined schedules and frequencies.
  • Provide support for the pre- approval inspection readiness efforts

Required Skills and Knowledge

  • Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EN ISO 14971:2012, ISO 13485)
  • Teamwork oriented and ability to lead and influence with proven problem-solving skills
  • Consistent application of technical principles, theories, concepts and quality sciences / tools and demonstrates knowledge of FDA/ISO requirements
  • Excellent communication and writing skills
  • Provide Risk Management technical expertise through the product life cycle for new and sustaining product development projects and platforms.
    • Demonstrate knowledge of risk management, regulatory and quality engineering policies, principles and best practices
    • Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies.
    • Collaborative work with quality, R&D, engineering, marketing and clinical.
    • Facilitate development and completion of risk assessments for field issues/complaints in the field.
  • Drive measurable improvements to Pfenex processes and procedures.
    • Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams;
    • Prepare/Revise policies/procedures based on industry standards for Quality Management Systems and Design Controls.
  • Provides guidance and direction on the use of analytical tools to assess product failure investigations.
  • Establishes compliant reporting risk management system to help facilitate timely, accurate, and sustained decision making to ensure appropriate compliant outcomes.
  • Works with medical personnel on creation of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.

QUALIFICATIONS

 Experience:

  • Bachelor's degree in technical field and 5-7 years of experience is required; or equivalent combination of education and experience.
  • Direct experience with combination products or devices and/or drug products/biologics in a regulatory environment
  • Combination product experience is preferred
  • Experience developing risk management policy and procedures for pharmaceutical/biologics/or medical device business is essential
  • Excellent computer, verbal, and written communication skills
  • Experience with cGMP Manufacturing and Quality Systems within a FDA regulated manufacturing environment.
  • Remains current on pharmaceutical regulations, industry standards, current practices, and new technology.

Education:

  • A Bachelor's degree in Engineering or Life Science preferred or specific biopharmaceutical experience required.

PHYSICAL DEMANDS

Additional Information 

  • Affirmative Action and Equal Opportunity Employer (EOE).
  • Pfenex celebrates the diversity of life and welcomes all individuals to apply.
  • Must be legally authorized to work in the US without sponsorship

 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Pfenex Inc.
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