Company Description Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.Job DescriptionThe Global VP of Analytical Research and Development will cultivate and grow a world-class analytical development organization passionate about designing novel and efficient analytical processes to manufacture and analyze active pharmaceutical ingredients while understanding the financial implications of science in business. This individual will cultivate the project profitability mechanism within the analytical development organization and team while working on new originators' business opportunities and bringing the latest analytical technologies to support the ongoing strategic initiatives at Veranova.This role will be responsible for leading the analytical research and development function by providing strategic direction, management of resources, scientific mentorship, and career guidance. Reporting directly to the chief technology officer (CTO), the VP of Analytical Research and Development will have significant visibility and influence across all Veranova sites and must establish and maintain strong partnerships with cross-functional groups. As part of the senior leadership team, will advise the executive committee to drive scientific efforts in the CDMO business globally to deliver on innovator and generic API projects.Key Responsibilities / Accountabilities
- Accountable for all aspects of small and large molecule analytical development including supporting preclinical and clinical drug candidates and commercialization/launch of innovator and generic API products.
- Develop future leaders as well as technical subject matter experts. Provide leadership to the analytical development team, including technical support, recruiting and retaining top talent, mentoring staff, and performance management.
- Oversee the development and transfer of analytical methods into the quality control process to ensure successful qualification, validation, and routine use in a quality control environment.
- Lead process analytical development, impurity characterization, technology transfer, process performance qualification (PPQ), and identification of life cycle management improvements.
- Partner with other department leaders and functions to support the development, transfer, and execution of manufacturing processes and with regulatory affairs to prepare regulatory filings and analytical reports to support process development.
- Develop novel analytical processes and suitable control strategies for APIs, intermediates, and regulatory starting materials.
- Direct analytical R&D in the process design, process characterization, process parameter criticality assessments, risk assessments (FMEA, pGTI, etc.), and linking of API bulk properties to drug product (DP) manufacturability and performance.
- Independently apply scientific knowledge (both theoretical and practical) for the resolution of analytical challenges. Uses outside resources (literature and specialty labs) to address complex problems.
- Introduce new analytical techniques and capabilities to the company while using a wide range of analytical and chemical knowledge to solve short and long-term problems.
- Provide content and reviews for analytical sections in proposals for analytical development projects, scientific reports, regulatory documentation, certificates, and other technical documents.
- Identify and drive life cycle management opportunities, including cost of goods, analytical cycle time reductions, and opportunities for disruptive innovation across the portfolio.
- Motivates, encourages, and inspires while promoting a continual learning culture where our scientists, chemists, and engineers relentlessly pursue innovation.
- Be a champion for growth and change introducing new development technologies, market segments for business growth tools, and platforms to drive efficiency, capability, and speed.
- Manage resources and budget planning, departmental objectives, individual project profitability, prioritization, projects acquisition, and assignments
- Leads and influences interdisciplinary projects involving analytical development, production, quality, regulatory, finance, and business units.
- Apply experience with technical writing for regulatory dossiers (IND, NDA, ANDA, DMFs, etc.) and develop strategic responses to global health authorities.
- Organize and participate in departmental committees to ensure that industry standards and best practices are applied.
- Advance the portfolio by leading and contributing to technical review gate meetings and phase reviews.
- Build & foster industry-academia collaborations to advance Veranova analytical technology platforms and projects.
- Collaborate with R&D groups in life sciences technologies as well as our biotech and pharma partners in manufacturing to advance and implement new analytical methods and technologies, including developing analytical methods for large molecules.
- Review data generated and supervise investigation of technical problems as needed from analytical prospectives.
- Interact with internal and external clients and respond to regulatory and scientific questions from those clients and regulatory agencies.
- Take on other duties within the employee's skills and abilities whenever reasonably instructed.
Qualifications
- PhD in Analytical or organic chemistry, preferably in analytical chemistry with 15 years of academic, post-doctoral, or pharmaceutical industry experience
- Or Master in analytical chemistry with a minimum of 15 to 20 years of relevant experience and demonstrated superior technical expertise in the CDMO environment.
- Extensive experience in drug substance analytical research and development is critical.
- Must possess the ability to lead, coach, and develop a team at all levels while exhibiting an adaptive management style with an ability to positively resolve conflict.
- It will be necessary to demonstrate strong analytical, written, and verbal communication skills to write clear and concise technical reports, presentations, and business correspondence.
- Must have strong business and financial acumen to understand the financial implications of science in business and cultivate the project profitability mechanisms within the analytical development organization.
- In-depth knowledge of the drug development process, especially as it applies to small, large, and bioconjugation molecules active pharmaceutical ingredients (APIs) is critical.
- Expert knowledge of current Good Manufacturing Practices (cGMP) is necessary.
- Ability to define problems, collect relevant data, recognize patterns, and draw conclusions from disparate information streams to make well-informed decisions promptly.
- Must have experience working in a multi-disciplinary team environment.
- Proven history of scientific excellence through presentations at conferences and publication of peer-reviewed manuscripts.
Additional InformationAll your information will be kept confidential according to EEO guidelines.Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.