VP Analytical Development (On-site Colorado)

Description

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

Core Values

This position is expected to operate within the framework of Tolmar's Core Values :

Education & Experience

Working Conditions

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Qualifications

Behaviors

Leader - Inspires teammates to follow them

Motivations

Ability to Make an Impact - Inspired to perform well by the ability to contribute to the success of a project or the organization

Education

PHD of Science (required)

Experience

15 years :

(required)

Skills

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.