Senior CMC Operations Lead

1 week ago

Bothell, Washington, United States Medix™ Full time

Senior CMC Operations Lead

The Senior CMC Operations Lead at Medix™ will spearhead the CMC initiatives at Contract Development and Manufacturing Organizations (CDMOs) for product development and scaling, cGMP production, process evaluation, and validation for Phase 3 clinical trials and commercial distribution. This role will also play a vital part in regulatory submissions and the formulation of policies and procedures to ensure adherence to the US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs).

Key Responsibilities:

  • Serve as Subject Matter Expert (SME) and guide the technical team at CDMO for late-stage recombinant protein drug development, encompassing tech transfer, scaling, risk assessment, process evaluation, and cGMP production.
  • Offer technical expertise and ensure project timelines are met while maintaining compliance with cGMP standards.
  • Review and authorize controlled documents, including batch records, Standard Operating Procedures (SOPs), protocols, and reports related to process development and evaluation.
  • Collaborate closely with Quality Assurance/Quality Control (QA/QC) to identify and assess deviations, Corrective and Preventive Actions (CAPA), and change control measures.
  • Lead and coordinate the efforts of partner organizations and consultants, fostering strong communication and relationships.
  • Guarantee compliance with internal processes and policies as well as regional regulatory requirements, emphasizing quality and precision in both verbal and written communication.
  • Work alongside CDMO for health authority inspections.
  • Accountable for project planning and tracking timelines, ensuring effective communication of commitments to team members.
  • Actively engage as a member of product support and new business development initiatives.
  • Contribute to US and international documentation supporting product development and maintenance, ensuring compliance with local regulatory requirements.
  • Adhere to all company policies, procedures, and safety regulations as outlined in the Employee Handbook and other communications.

Preferred Education:

  • University-level degree in a scientific discipline or equivalent qualification.

Preferred Experience:

  • At least 5 years of experience in process development and CMC operations, with a preference for experience in biologics.
  • Strong knowledge of drug product process validation and manufacturing for lyophilized recombinant protein drugs is essential.
  • Desirable expertise in protein production and purification for clinical and commercial applications.
  • Experience in formulation development is advantageous.
  • Comprehensive understanding of regulatory requirements from the FDA and other regulatory bodies.

Knowledge, Skills, and Abilities:

  • Willingness to undertake a diverse range of responsibilities in a smaller organization, both independently and as part of a team.
  • Exceptional oral and written communication skills; ability to effectively engage with colleagues and health authorities.
  • Proficiency in MS Office Suite [Excel, Word, PowerPoint, MS Project], JMP statistical software, and Adobe Acrobat.
  • Willingness to travel as required by projects (10-25% of the time, both domestically and internationally).
  • Flexibility to work varied hours to facilitate collaboration with international CDMOs and partners.

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