Head of Chemistry, Manufacturing & Controls
Head of Chemistry, Manufacturing & Controls
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$ 160000 - 230000
1 Vacancy
Job Description
About Absci
Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation platform combines cutting-edge AI models with a synthetic biology data engine enabling the rapid design of innovative therapeutics that address challenging therapeutic targets.
Absci is a global company headquartered in Vancouver WA and maintains offices in New York City Switzerland and Serbia. Learn more at or follow us on LinkedIn (@absci) X (@Abscibio) and YouTube.
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 Abscis 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 Abscis 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:
- Bachelors 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: Abscis 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 $160000- $230000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge skills and 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.
Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex sexual orientation gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information marital status or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should request the recruiter or hiring manager or contact .
Required Experience:
Director
Employment Type
Full-Time
