Director of Analytical Development

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 Description

The Director of Analytical Development plays a vital role in the Site Leadership Team. Tasked with driving end-to-end, phase-appropriate analytical development for all drug substances, the Director ensures excellence from method conceptualization to GMP support. Collaborating seamlessly as a global team member, this role is critical in bridging the gap between chemical development and quality control while ensuring top-notch client communication and project success.

Key Responsibilities / Accountabilities

• End-to-end Development: Spearheaded the end-to-end phase-appropriate analytical development for all drug substances, ensuring alignment with organizational and regulatory standards.
• Method Implementation: Lead the design, implementation, and execution of advanced analytical methods, focusing on HPLC, GC, and LC/MS techniques.
• Resource Allocation: Strategically allocate resources for projects, guaranteeing timely delivery of all objectives related to analytical development phases.
• Regulatory Compliance: Drive the development and validation of analytical methods following stringent regulatory guidelines, addressing any FDA discrepancies proactively.
• GMP Support: Provide robust initial GMP support, ensuring the seamless transition of analytical methods from development to production stages.
• SOPs and Documentation: Oversee the creation and maintenance of SOPs, test methods, and all related GMP documentation while ensuring the accuracy and reliability of data presented by analysts.
• Tech-Transfer Initiatives: Guide and influence tech-transfer and validation projects across the organization, ensuring effective and efficient transfer from R&D to production.
• Problem Resolution: Act as the primary subject matter expert in resolving intricate analytical issues, offering guidance and solutions to challenges as they arise.
• Team Leadership: Mentor, coach, and lead the analytical team, fostering a culture of continuous learning and best practice adoption.
• Stakeholder Communication: Foster deep ties with both internal teams and external clients, ensuring all communications are clear, proactive, and solution oriented.
• Financial & Non-Financial Metrics: Metrics will be tailored to business goals and communicated during onboarding.
• Working Relationships: Cultivate relationships with senior management, R&D teams, production teams, external clients, and other stakeholders.
• Nature of Impact: Provide strategic direction and hands-on leadership, exerting influence over vital decisions related to drug substance development.
• Magnitude: Play a central role in the success of drug substance development projects, with an evident influence on business outcomes.

Qualifications

• PhD in Analytical Chemistry or master’s in chemistry or relevant field with at least 15 years of in-depth industrial experience.
• Demonstrable leadership experience in GMP settings, with a track record of successfully driving teams and significant projects.
• Strong leadership in coaching and mentoring the teams for successful project delivery.
• In-depth knowledge of method development and validation concerning APIs.
• Mastery using HPLC, GC, GC-MS, LC-MS, IC, spectroscopy, and wet chemistry.
• A history of successful mentorship, coaching, and team leadership.
• Proven skills in method validation protocols, reports, and relevant software such as Microsoft Office, UPLC, and Empower 2.
• Superior analytical, written, and verbal communication skills are essential.
• Excellence in client communication and relationship management.
• Ability to interpret scientific journals and regulatory documents and produce comprehensive technical reports.

Additional Information

All 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.