VP Analytical Development (On-site Colorado)

Purpose and Scope

Oversees the analytical development of Tolmar’s overall portfolio of products and technologies. Pursues and manages all analytical CMC activities needed to support the design of new products that span multiple therapeutic areas through research, development, and clinical studies to bring a product to market in compliance with global regulatory, scientific, and legislative standards and requirements. This position functions as the scientific liaison to business partners and thought leaders in areas of interest to the company.

Essential Duties & Responsibilities

• Evaluate and monitor the department’s objectives and operations to ensure alignment with overall company objectives.
• Serve as a strategic scientific leader in evolving the company's research and development programs, including generics, proprietary, and long-acting injectable portfolio, including drug-device combination products.
• Set near-term and long-term strategic directions of the department aligned with R&D objectives and deliverables, to ensure delivery of the company's product pipeline.
• Manage all lab activities related to the development and optimization of robust analytical methods aimed at quantification of raw materials, APIs, intermediates, and finished products for timely clinical supplies.
• Work with both internal and external stakeholders to develop phase-appropriate analytical strategies to support the seamless progression and transition of projects from candidate selection through product licensure and launch.
• Provide technical leadership and guidance for troubleshooting and problem-solving activities related to processes and laboratory investigations.
• Collaborate with Product Development, MS&T, Manufacturing, Marketing, and Quality Assurance departments to coordinate production and release of new products.
• Act as liaison between department management and subordinate levels, as well as executive and department-manager levels, to inform personnel of communications, decisions, policies, and all matters that affect their performance, morale, and results.
• Implement appropriate SOPs and ensure SOP and GLP compliance.
• Assure appropriate communications of project status and issues.
• Manage sustainable talent development to recruit, develop, and retain top talent in all functional areas to deliver project objectives.
• Lead/participate in senior cross-functional matrix CMC steering teams to provide technical guidance for all analytical related activities.
• Participate in due diligence activities to provide critical analytical assessment in business development efforts.
• Oversee regulatory submissions and communications related to analytics and supporting regulatory filings.
• Cultivate a team culture that respects Tolmar's core values and innovation and promotes teamwork and collaboration.
• Foster and maintain expectations of compliance with quality, safety, confidentiality and corporate integrity standards / policies.
• Develop a budget for functional areas, manage and allocate resources, and monitor expenditures.
• Write and/or review technical documents (internal reports, external disclosures, regulatory documents, etc.).
• Establish and leverage strategic relationships with CRO’s and academia to access emerging innovations.
• Perform other related duties as assigned. 

Knowledge, Skills & Abilities 

• Demonstrated understanding of analytical development and be able to think critically and strategically about how analytics relate to CMC development path and product life cycle management.
• A demonstrated ability to establish a root cause. A candidate must display a working aptitude to systematically analyze a problem to find its fundamental source rather than addressing symptoms.

• Broad-based technical expertise necessary to lead the development of generic and proprietary pharmaceutical products.
• Prior leadership role in analytical development specializing in specialty injectables, long-acting injectable products involving polymer, small molecules, and protein/peptides.
• Entrepreneurial mindset with the ability to take intelligent risks, competence in analysis, solving problems, and prioritizing and making difficult trade-off decisions to achieve overall business objectives.
• Strong data analysis, interpretation, and documentation skills.  Specific experience in Chromeleon software would be desirable.
• Expert knowledge of FDA, International, and cGMP regulations & guidelines.
• Excellent planning skills, including resource allocation and timeline development.
• Skill in effective oral and written communication. 
• Proven interpersonal