Chemistry, Manufacturing & Controls

Summary

Join Absci, a data-first AI drug creation company, as their Head of Chemistry, Manufacturing & Controls (CMC)! This remote or hybrid role, based in Vancouver, WA, will see you driving CMC development, scale-up, cGMP manufacturing, and quality control processes for Absci’s AI-generated antibody assets. You will coordinate CMC efforts in CDMOs, manage project budgets, and ensure compliance with cGMP regulations. Strong technical expertise in chemistry and manufacturing, excellent communication skills, and experience in technical writing and biologics regulations are essential. The role involves collaboration with internal and external stakeholders, including CDMOs and vendors. Occasional travel is required.

Requirements

• Bachelor’s degree in a technical field such as chemistry, chemical engineering or pharmaceutical sciences
• Recommended to have 10 to 15 years of industry experience in pharmaceutical development and manufacturing, with a focus on CMC; required knowledge of the biologics development process; experience interacting with key functional stakeholders such as manufacturing, QA, QC, and supply chain
• Experience in planning and managing resources to deliver predetermined objectives as specified by more senior managers (Over 3 years to 6 years)
• Proven track record of successfully developing and setting strategy for CMC programs from development through commercialization
• Flexibility to work non-traditional work hours when needed, given international operations across time zones
• Ability to create and deliver presentations to influence and inform individuals across functions and levels within the organization
• Ability to travel up to 10% of the time. This will include outside of the United States

Responsibilities

• Function as technical leader at contract development and manufacturing organizations (CDMOs) for early-phase biologics for development of both Drug Substance and Drug Product, including upstream and downstream development, gap/risk analysis, cGMP manufacturing, release, and stability
• Provide technical guidance for cell line development, upstream process development, downstream process development, formulation development, analytical development, and drug product development
• Review and approve controlled documents, including batch records, SOPs, protocols, and reports related to process development and characterization
• Preparation of program/platform dashboards and presentations
• Manage project budgets to target
• Ensure that senior management/development teams are informed of important program timelines, milestones, and risks
• Responsible for tracking commitments and communications with external vendors and providers
• Keep projects in compliance with cGMP regulations
• Coordinate activities to ensure efficient and cost-effective project completion
• Coordinate production of commercial batches as needed
• Work closely with QA to identify and evaluate deviations, CAPA and change control
• Serve as a liaison between internal stakeholders and external partners, such as contract development and manufacturing organizations (CDMOs) and vendors
• Lead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants
• Collaborate with clinical operations to ensure deliverables meet development plans
• Adhere to all company policies, procedures and safety rules

Preferred Qualifications

An advanced degree is preferred

Benefits

• Medical, dental, vision insurance
• Unlimited vacation
• Parental leave
• Employee assistance program
• Voluntary life and disability insurance
• Annual bonus potential
• 401(k) with a generous company match