Senior Director

Senior Director, Analytical Sciences

Reporting to the Senior Vice President of Technical Operations, the Senior Director of Analytical Sciences and Quality Testing (ASQT) will lead the ASQT team within Technical Operations and be responsible for establishing overall analytical strategies, analytical method development, method qualification, method validation, method transfer, early-stage testing, CQA and product characterization; comparability strategies and analytical control strategies; authoring and reviewing regulatory submission and participating in interactions with Health Authorities; and mentoring, managing and inspiring staff in the team.

This is a leadership role in both the product development and the organization. The role requires strong technical expertise, passion, strategic thinking, and collaboration with internal and external teams, including Process Development, Manufacturing, Quality, Regulatory, Facility, partners, and vendors. The individual will serve as a collaborator and a scientific and technical leader on a variety of teams within the company and will represent the company in the same roles during interactions with regulatory agencies, partners, and vendors.

Responsibilities:

• Lead, manage, mentor, and inspire the ASQT team
• Own the ASQT budgets associated with projects, capital equipment and staffing (internal and consultants)
• Establish overall analytical strategies, including analytical development plans, comparability strategies and analytical control strategies
• Lead analytical method development, optimization, transfer, qualification, and validation. Product characterization. CQA and analytical control strategy. Product specifications. Comparability. Early-stage analytical testing (cGMP and non-GMP)
• Maintains current state-of-the-art practices and methods according to industry standards and regulatory guidelines
• Author and review regulatory submissions
• Represent ASQT in project teams, product development teams, company initiative task forces, and collaborations with partners
• Oversee the review and approval of analytical laboratory documentation, including (but not limited to) technical reports, method transfer/qualification/validation protocols and reports, investigation protocols and reports, stability protocols, certificates of testing/analysis
• Oversee the review and approval of manufacturing batch records with respect to sampling plans and analytical testing
• Establish goals, design experiments, analyze and review data, recommend and plan actions to achieve project objectives, including establishing and assuring adherence to schedules, work plans and performance requirements
• Support the evaluation and selection of contract facilities, including request for proposals, review of proposals, and assessment of contract analytical and manufacturing organizations
• Provides scientific/technical guidance, leadership, and decision-making across the company, including non-analytical functions, as appropriate
• Regularly interact with senior management as required
• Support due diligence as required

Qualifications:

• Ph.D. with 10+ years, MS with 15+ years, or BS with 18+ years of relevant method experience
• Degree in analytical chemistry, chemistry, biochemistry, pharmaceutical sciences, or related field required
• A broad understanding of analytical strategies for large molecule drug substances and drug products, especially monoclonal antibody therapeutics
• Demonstrated ability to manage test method transfer
• Direct experience with analytical comparability and analytical control strategy
• Direct experience with analytical method development, validation, and stability evaluations
• Demonstrated technical proficiency of analytical methodologies for release and stability testing
• Proven ability to lead in a team environment to solve complex technical challenges
• Experienced with regulatory submission and regulatory requirements for protein therapeutics
• Knowledge of relevant GMP and quality guidelines
• Ability to effectively represent the company with external partners
• Excellent oral and written communication skills
• Leadership and managerial experience
• Embodies the company values; exhibits high degree of integrity and professionalism when interacting with outside investigators and vendors
• Entrepreneurial and enjoys working in a fast-paced, creative, and resourceful small company environment
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)