Manager of Biologics Development and Manufacturing (CMC) (WA)

Key Responsibilities:

Strategic Execution:

• Serve as the technical lead at Contract Development and Manufacturing Organizations (CDMOs) for early-phase biologics drug development, covering both Drug Substance and Drug Product. Responsibilities include tech transfer, scale-up, gap/risk analysis, process characterization, and cGMP manufacturing.
• Provide technical leadership in areas such as cell line development, upstream and downstream process development, formulation development, analytical methods, and drug product development.
• Review and approve controlled documents, including batch records, SOPs, protocols, and reports related to process development and characterization.
• Prepare dashboards and presentations for program and platform progress.
• Oversee and manage project budgets, ensuring alignment with financial targets.

Project Management:

• Lead planning and tracking of project timelines and commitments, ensuring clear communication with team members.
• Ensure compliance with cGMP regulations for all projects.
• Coordinate activities to ensure projects are completed efficiently and cost-effectively.
• Manage commercial batch production as needed.
• Keep senior management and development teams informed about critical program timelines, milestones, and risks.

Cross-Functional Collaboration:

• Collaborate with QA/QC teams to identify and assess deviations, CAPA, and change control.
• Act as the primary liaison between internal teams and external partners, including CDMOs and vendors.
• Lead and guide partner organizations and consultants, ensuring strong communication and relationship-building.
• Work with CDMOs to prepare for health authority inspections.
• Adhere to company policies, procedures, and safety standards.

Qualifications:

Educational Background:

• Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, or a related technical field. An advanced degree is preferred, and project management training is a plus.

Professional Experience:

• At least 3 years of experience in pharmaceutical development and manufacturing, with expertise in Chemistry, Manufacturing, and Controls (CMC) for biologics.
• Experience working with key stakeholders in manufacturing, QA, QC, and supply chain.
• Flexibility to work outside traditional hours due to international operations spanning different time zones.
• Proven ability to prioritize tasks, manage multiple projects, and perform in a dynamic, high-pressure environment.
• Proficiency in MS Office (Excel, Word, PowerPoint, MS Project), JMP statistical software (preferred), and Adobe Acrobat.
• Skilled in developing and delivering presentations to inform and influence individuals across various functions and organizational levels.
• Ability to travel up to 10%, including international travel.

Preferred Qualifications:

• Strong expertise in cell line development, upstream and downstream process development.
• Experience in formulation development is highly desired.
• Comprehensive understanding of regulatory requirements from the FDA and other regulatory agencies.
• Proven track record in supporting CMC programs from development to commercialization.
• Demonstrated ability to manage multiple projects and prioritize effectively in a fast-paced environment.
• Industry experience in biotech, pharmaceuticals, or healthcare.

This is a full time position