Senior Manufacturing Engineer, Drug Products (JS20-254)

Catalyst Biosciences (Catalyst, CBIO) is seeking a passionate, experienced, and collaborative Senior Manufacturing Engineer, Drug Products for its South San Francisco headquarters. The position reports directly to the Executive Director, Drug Product Manufacturing in the Biologics Development and Manufacturing department and offers a highly visible opportunity to make a significant impact by contributing to internally and externally partnered biologics product 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 Engineer, Drug Products supports Catalyst’s Drug Product operations by execution or oversight during GxP process development and manufacturing of biologics drug products. The Senior Engineer, Drug Products ensures Catalyst’s compliance with applicable GxP biologics drug product requirements and correspondingly develops and maintains Catalyst’s biologics drug product policies and procedures while aligning with existing company policy. The incumbent manages all aspects of GxP drug product process development 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 drug product process development and manufacturing, including supply, compliance, and inspection-readiness.

Responsibilities

  • Develop, maintain, and improve GxP policies and procedures to ensure biologics drug product 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 biologics drug 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 biologics drug 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 drug product contract organizations and vendors, including coordination, communication and oversight, to ensure timely development and delivery of GxP 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 preparation of Catalyst’s health authority submissions
  • Support regulatory inspections at Catalyst and contract organizations
  • Execute other departmental 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 preferred
  • Twelve (12) or more years of experience in biologics drug product manufacturing or related 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 biologics drug product regulations, requirements, and guidelines
  • 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 (JS20-254) in the subject line.