Associate Director – Global Chemistry Laboratory Operations & Governance

Vantive•Oakdale, MN

1d•Hybrid

About The Position

This Associate Director – Global Chemistry Laboratory Operations & Governance role at Vantive R&D provides technical, people, and compliance leadership for chemistry activities most relevant to Vantive’s global drug and device product portfolio. This role has direct people, laboratory, and project execution responsibility for US-based chemistry laboratories, leading a wet chemistry team of approximately 8–10 scientists performing extractables and leachables (E&L), analytical chemistry, stability, and materials compliance testing as well as data scientist(s) for data analysis and digital tools specialist(s) for streamlining lab workflows. In addition, this role holds global accountability for governance of chemistry laboratory (which would cover analytical chemistry, stability, extractables and leachables (E&L), and materials compliance testing labs) compliance across all internal and external laboratories supporting Vantive products. This would include Vantive internal labs in US, Ireland and India and external Contract Research labs (CROs) across the globe. The Associate Director serves as the primary R&D interface with Regulatory and Quality functions for all chemistry laboratory–related matters globally, and as the primary compliance interface with all external chemistry laboratories, contract testing organizations, and other related suppliers. The role orchestrates execution of critical chemistry activities through deep domain expertise in chemistry applications in drug and device product portfolio, a strong compliance mindset, cross-functional collaboration, and an agile, problem-solving approach. This individual works closely with R&D peers and cross-functional leaders to ensure chemistry strategies enable compliant, safe, and effective products for global patients.

Requirements

A Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related STEM disciplines is required.
15+ years of relevant experience, including significant experience in regulated laboratory environments (e.g., GMP) and interaction with internal regulatory and quality organizations as well as governmental agencies like FDA, EMA for drug and device product portfolio.
Demonstrated hands-on (in at least one of the areas) and leadership expertise in extractables and leachables (E&L), analytical chemistry, stability, and materials compliance within regulated laboratory environments.
Strong working knowledge of global regulatory and quality expectations (e.g., cGMP) applicable to chemistry laboratories and external testing organizations.
Proven experience leading laboratory-based scientists and setting technical direction in a wet chemistry environment.
Demonstrated experience acting as a senior technical interface with Regulatory Affairs, Quality, external laboratories or suppliers and government regulatory bodies like FDA, EMA, and others.
Hands-on experience supporting analytical method development and validation, stability programs, chemical investigations, and materials compliance testing.
Ability to design and implement scientifically sound, regulation-compliant, and operationally efficient laboratory strategies.
Strong communication, mentoring, and decision-making skills.
Self-motivated, collaborative leader with strong interpersonal and problem-solving skills.
Leadership experience managing teams of around 10 or more is required.
Demonstrated experience in working in global teams – especially in people leadership and/or strategic leadership roles is highly desired.

Nice To Haves

The successful candidate will demonstrate a passion for advancing scientific innovation in a highly regulated environment, consistently seeking opportunities to optimize laboratory operations and support new product development initiatives.
They will thrive in a collaborative setting, leveraging their technical, compliance, and leadership skills to drive continuous improvement and contribute to the achievement of organizational goals.
Adaptability, strategic vision, and the ability to build strong relationships across global teams will be essential to ensure the ongoing success and compliance of Vantive's chemistry laboratories.

Responsibilities

Provide direct people leadership for a US-based wet chemistry laboratory team (~8–10 scientists) performing extractables and leachables (E&L), analytical chemistry, stability, and materials compliance testing.
Own global governance of chemistry laboratory compliance (e.g., GMP) for all laboratories supporting Vantive products.
Serve as the primary and accountable R&D interface with Regulatory Affairs and Quality functions for all chemistry laboratory–related matters globally.
Act as the primary global technical and compliance interface with all external chemistry laboratories, contract research/testing organizations, and analytical suppliers.
Prioritize, direct, and personally own critical chemistry activities across strategic and tactical projects being executed in US chemistry labs supporting both on-market products and new product development.
Ensure inspection of readiness for chemistry laboratories and support audits, inspections, and regulatory interactions involving internal and external laboratories.
Contribute to and maintain the Chemistry and Laboratory Technology Roadmap.
Work with cross-functional stakeholders and peers to design and implement laboratory strategy across extractables and leachables, analytical chemistry, stability, and materials compliance.
Proactively engage in scoping, ideation, and key product development decisions.
Coach and mentor laboratory scientists to foster a culture of scientific excellence, compliance, collaboration, and continuous improvement.
Collaborate closely with R&D peers and cross-functional stakeholders on strategy, resource allocations, and program execution.

Benefits

medical, dental and vision coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
the Employee Discount Program
the Employee Assistance Program (EAP)
childcare benefits