Senior Director CMC Analytical Development
HQ- Cambridge, MA /
CMC & Quality /
Salaried, full-time
/ On-site
The Sr. Director will have a highly visible role within the company to lead the strategy and execution of CMC analytical development activities to support the characterization of complex gene-editing drug products. The successful candidate will enjoy working in a fast-paced environment, collaborate with research scientists and communicate clearly with internal and external stakeholders. The ideal candidate will enjoy working in cutting edge technology, embrace challenges and build a strong team. This role requires proven technical experience in developing complex analytical assays in support of GMP products, a broad understanding of the regulatory environment, and to champion Arbor’s needs with external organizations.
Responsibilities
- Accountable for the appropriate build of internal CMC analytical capabilities and identification and management of external laboratories (CDMOs) to develop and implement analytical tools for the characterization and release of gene editing products.
- Work collaboratively with research scientists, Process Development, Manufacturing, Quality Control, Regulatory and Quality Assurance to provide strategic and technical expertise in analytical methods and testing.
- Responsible for establishing critical quality attributes to support Arbor’s clinical development programs.
- Leadership skills that promote a positive results-oriented culture while maintaining confidence in Biopharmaceutical development capabilities to resolve complex problems.
- This role will be involved in activities related to analytical testing, method transfer, validation, laboratory investigations/deviations and regulatory applications/inspection.
- This role will support the evaluation of external QC laboratory capabilities, and the harmonized execution of analytical methods across the CDMO network.
- Author, review and/or approve technical reports, risk assessment, investigation, deviation, change control and/or other technical documents.
- Author and review relevant regulatory submission documents and provide strategic guidance on regulatory interactions relating to analytical methods, specifications, and control strategy.
- Work cross functionally and manage relationships with external stakeholders.
- Develop budget proposals and manages execution of approved budgets and building internal teams.
Requirements
- Degree in science (preferably a Ph.D.), with demonstrated leadership experience and subject matter expertise in analytical development and at least 10+ years in a biopharmaceutical organization.
- Knowledge of cGMPs and Regulatory guidelines as well as expertise in laboratory techniques commonly used in the analysis of cell and gene editing products is required.
- Ability to work both independently and in a matrix team environment.
- Expert level technical skills and experience with design, execute, and document analytical method development, validation, transfer in support of process development, product release and stability.
- Manage/lead external and/or internal CMC analytical characterization activities. Support the development of product specification and control strategy.
- Experience with LNP, mRNA or AAVs is desired.
- Broad knowledge of the relevant cGMPs, ICH guidelines and QBD principles.
- In-depth experience with analytical methods that meets US FDA, UK and/or EU regulatory requirements.
- Demonstrated experience with authoring CMC sections of regulatory submissions. Experience interacting with regulatory authorities via scientific advice meeting, inspection etc.
- Self-motivated, detail-oriented, strong interpersonal skills and can participate and work effectively on multiple cross-functional teams.
- The ability to work in a fast pace, matrix environment; problem solver with a hands-on approach, manage priorities and maintain timelines for multiple projects.
Our Values:
Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us!
· Purposeful Action: Start with The Why
· Bold Resilience: Adopt a Growth Mindset
· Humble Authenticity: Start in the Heart
About Arbor:
At Arbor, we are discovering, developing and making available to all patients the next-generation of genetic medicines. We are disrupting the field through our proprietary discovery engine to develop a portfolio of differentiated genetic editing and delivery capabilities. We have an unencumbered portfolio of multiple CRISPR based genetic modifiers that can be tailored to correct the underlying pathology of each genetic disease. Our pipeline of genetic medicines will focus on bringing cures to all patients with genetic disease.
We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional.
We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.
