Head of Chemistry, Manufacturing & Controls

Head of Chemistry, Manufacturing & Controls (CMC) 

Remote or Hybrid, Vancouver, WA

Our Head of CMC will drive the CMC development, scale-up, cGMP manufacturing, and quality control processes to advance Absci’s internal pipeline of AI-generated antibody assets. The leader of CMC will be solely responsible for coordinating the CMC efforts in CDMOs, driving timelines of Absci’s early-phase biologics. This role requires a blend of technical expertise in chemistry and manufacturing processes, and strong internal and external communication skills. This role will also contribute to regulatory filings, requiring strong experience in technical writing and biologics regulations. Occasional travel is required. 

Responsibilities: 

Strategic Development

• 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.

Management of external vendors and providers

• 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. 

Cross-Functional Collaboration 

• 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.

Qualifications:

Educational Background: 

• Bachelor’s degree in a technical field such as chemistry, chemical engineering or pharmaceutical sciences. An advanced degree is preferred. 

Professional: 

• 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.

How We Thrive Together: Absci’s Core Values

• We are one team with one finish line: You will foster strong cross-functional collaboration, ensuring smooth information flow from development to manufacturing. 
• We embrace our differences: You will value and leverage the diverse backgrounds and perspectives within our team to create more robust solutions together.
• We deliver Results: By proactively driving project timelines and troubleshooting technical challenges, you will ensure the reliable delivery of high-quality products.
• We do the right thing: You will uphold the highest standards of quality and compliance, working transparently with regulatory agencies and partners to build trust and accountability.
• Innovate because lives depend on it: You will champion the implementation of novel manufacturing technologies and CMC strategies, supporting our mission to bring life-changing medicines to patients faster.
• We believe in the impossible: You will embrace experimentation, rapidly learn from setbacks, and translate those lessons into continuous CMC and process improvements.

The salary range for this position is $160,000- $230,000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, vision benefits and ability to participate in our employee stock purchase plan.

Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, breakfast and lunch for onsite employees, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match. Legal authorization to work in the United States is required.