Tolmar · 1 day ago
VP Analytical Development (On-site Colorado)
Fort Collins, CO
Full-time
Onsite
Director/Executive
$300K/yr - $325K/yr
15+ years expTolmar is a company focused on pharmaceutical development, and they are seeking a VP of Analytical Development to oversee the analytical development of their product portfolio. This role involves managing all analytical CMC activities, collaborating with various departments, and ensuring compliance with regulatory standards to bring products to market.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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
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 and leadership skills
Ability to interact and influence successfully across boundaries with cross-functional areas and disciplines
Ability to manage, direct, lead, and coordinate others
Expert knowledge of Electronic Lab Data systems, advanced statistical analysis, and implications to 21 CFR part 11 and global regulations
Master's or Ph.D. in Pharmaceutical Chemistry, Chemistry, Biochemistry, Chemical Engineering or related field with demonstrated ability to lead successful programs
Fifteen plus years of related pharmaceutical or biotech research and development experience required
Ten years of demonstrated leadership of large teams (20+ FTEs) with the ability to drive a positive environment and culture that fosters ownership, accountability, empowerment, and the development of team members, which will enable the progression of their scientific and managerial career paths
Demonstrated experience utilizing a Quality by Design approach in product development
Preferred
Specific experience in Chromeleon software would be desirable
Benefits
Bonus eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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