Senior Engineer, Combination Products (JS20-253)

Catalyst Biosciences (Catalyst, CBIO) is seeking a passionate, experienced, and collaborative Senior Engineer, Combination Products for its South San Francisco headquarters. The position reports directly to the Executive Director, Drug Product Manufacturing in the Technical Operations department and offers a highly visible opportunity to make a significant impact by contributing to internally and externally partnered combination product design and development programs in a fast-growing company.

ABOUT CATALYST BIOSCIENCES

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet medical needs in patients with rare bleeding and complement related disorders. Catalyst currently has compounds in discovery and development phases that span the value chain from the early discovery stage to late stage clinical trials with the intent of commercialization.

The Senior Device Engineer, Combination Products supports Catalyst’s Drug Product operations by execution or oversight during design, development, and manufacturing of combination products (biologics product plus medical device). The Senior/Principal Engineer ensures Catalyst’s compliance with applicable GxP and combination product requirements (e.g., health authorities, ISO) and correspondingly develops and maintains Catalyst’s combination product policies and procedures while aligning with existing company policy. The incumbent manages all aspects of combination product design controls as well as production. The incumbent executes independently and represents Drug Product Manufacturing in cross-functional interactions with internal departments and external contract organizations, testing organizations, or vendors. The role requires regular interaction with the Executive Director, Drug Product Manufacturing on matters related to combination product design and manufacturing, including supply, compliance, and inspection-readiness.

Responsibilities

  • Develop, maintain, and improve GxP policies and procedures to ensure combination product design, development, and manufacturing is conducted in accordance with appropriate regulations, guidelines, and procedures
  • Support selection, management, and inspection readiness of GxP contract organizations or vendors by performing capability reviews and gap analyses
  • Interact with the development and manufacturing units of contract organizations or vendors to ensure that Catalyst’s interests are met while relationships are maintained
  • Partner across the business to ensure effective management, timely execution, and continuous improvement of clinical and commercial combination product processes
  • Develop strong working relationships and work collaboratively with internal stakeholders (e.g., Regulatory Affairs, Quality Assurance, Project Management, and Clinical Operations)
  • Provide technical oversight, including planning, budgeting, scheduling, risk management, and execution, to ensure requirements are met for combination products during:
    • Development of contracts and quality agreements for contract organizations
    • Medical device design (feasibility, development, controls, risk management, verification, and validation)
    • Manufacturing process development, validation, and continuous verification
    • Analytical test development, including transfer, verification, or validation
    • Manufacturing, assembly, and packaging including risk management, change management, deviation management, testing, stability, batch review, and metrics
    • Medical device technology transfers and scale-ups
    • Transition from clinical to commercial operations
  • Manage relationships with combination product contract organizations and vendors, including coordination, communication and oversight, to ensure timely development and delivery of GMP products to support clinical trials
  • Escalate project or resource issues and risks to program and functional management (integrated risk management)
  • Prepare high quality presentations in partnership with Catalyst teams for communication with internal and external stakeholders
  • Ensure transparent communication of activities and status across teams and to key stakeholders
  • Support quality engineering reviews
  • Develop or assess sampling systems, procedures, and statistical techniques
  • Devise or evaluate quality tests and define test criteria
  • Evaluate product complaints and failure mechanisms
  • Support preparation of Catalyst’s health authority submissions
  • Support regulatory inspections at Catalyst and contract organizations
  • Execute other Technical Operations or Catalyst projects or initiatives

**Title/Level to commensurate with education and experience.

Requirements

  • Bachelor’s degree in chemical engineering, mechanical engineering, biomedical engineering other related scientific or engineering discipline; advanced degree (MS or PhD) preferred
  • Twelve (12) or more years of experience in combination product or related medical device roles in the biopharmaceutical industry; experience must include global clinical and/or commercial environments supporting development, commercialization, and operations support
  • Working knowledge of global GxP, medical device, and combination product regulations, requirements, and guidelines (e.g., Design Control (21 CFR 820), ISO 14971, and ICH)
  • Ability to apply sound judgment and decision-making skills (risk-based and appropriate for the phases of clinical development and commercial production)
  • Demonstrated experience successfully managing external collaboration partners
  • Proven track record of strategic thinking, innovative problem solving, and achieving results
  • Ability to independently and proactively organize and prioritize work while managing multiple tasks in a fast-moving matrix environment while ensuring alignment with internal and external stakeholders
  • Ability to deal with ambiguity
  • Strong verbal and written communication skills
  • Leadership and influencing skills
  • Collaborative, diplomatic, and tactful
  • Travel required – global, up to 25%

 

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (JS20-253) in the subject line.