DescriptionReporting to the Executive Director, Analytical Development, the Associate Director, Analytical Development is primarily responsible for implementation of analytical strategies for assigned programs to support Viridian's development pipeline and contribute to sustained clinical supply through timely analytical deliverables. This is a hands-on, individual contributor role overseeing analytical workflows for multiple programs at all stages of development. This role entails significant collaboration with internal cross-functional groups as well as oversight of external CDMO/CRO partners.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):- Provide technical guidance, and tactical direction for assigned Analytical Development projects from pre-clinical through commercialization, in alignment with broader program and functional strategy
- Manage activities including method assessment, development, transfer and validation to support release and stability testing of drug substances and drug products
- Provide detailed review and approval of analytical methods, development reports, validation protocol and reports, stability protocol, etc.
- Manage and provide technical guidance to support investigations, quality events and development studies at CDMO/CROs
- Author and review technical reports, technical data packages and relevant CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs, etc.)
Requirements- Master's degree in biochemistry, analytical chemistry or related field with 10+ years of experience or a PhD with 6+ years of experience in analytical development/sciences
- Demonstration of increasing responsibility in project and people management project leadership and cross-functional/external partner management
- Extensive hands-on experience in analytical testing of protein therapeutics is required
- Experience with broad analysis and characterization of monoclonal antibodies is preferred
- Strong subject matter expertise in biophysical/biochemical OR potency assays for protein therapeutics
- Experience with high concentration OR combination products is preferred
- Experience with execution and/or oversight of analytical method development, transfer and phase-appropriate validation
- Broad understanding of cGMP requirements, compendial testing, and regulatory guidance with respect to development and testing of biological therapeutics
- Direct experience authoring of analytical, stability and comparability sections of regulatory documents. Experience with BLA and MAA preparation is preferred
- Excellent interpersonal and communication skills (written and oral), including the ability to effectively present data to peers, management and external partners
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast-paced environment and to handle multiple tasks
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 10%
- The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
- Competitive pay and stock options for all employees
- Medical, dental, and vision insurance
- 100% Paid Parental Leave
- Short- and long-term disability coverage
- Life, Travel and AD&D
- 401(k) Company Match with immediate company vest
- Employee Stock Purchase plan
- Generous vacation plan and paid company holiday shutdowns
- Various fertility, mental, financial, and proactive physical health programs
