Director of Chemical 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, Chemical Development will oversee an organization of process chemists to deliver on Veranova’s portfolio of Innovator and Generic API projects.

The Chemical Development organization is responsible for the design of efficient, robust, and scalable chemical processes for APIs that can be moved rapidly from the laboratory to the manufacturing plant. The group works closely with Analytical Development, Quality, EHS and Manufacturing Operations to support the development, transfer, and execution of manufacturing processes, as well as with Regulatory Affairs for the preparation of regulatory filings.

The successful candidate will be responsible for leading the Chemical Development function by providing strategic direction, management of resources, scientific mentorship, and career guidance. As a strong communicator, this individual will partner with other department leaders both locally and globally to drive the scientific engine of Veranova.

Key Responsibilities / Accountabilities

• Accountability spans all aspects of small molecule process development, including support of preclinical and clinical drug candidates as well as commercialization/launch of innovator and generic API products
• Leadership for chemical process development, process characterization, technology transfer, process performance qualification (PPQ) and identification of life cycle management improvements
• Development of novel synthetic processes and suitable control strategies for APIs, intermediates, and regulatory starting materials
• Direct chemical R&D related to process design, process characterization, process parameter criticality assessments, risk assessments (FMEA, pGTI etc.) and linking of API bulk properties to DP manufacturability and performance
• Accountable for project teams, process development laboratories, Kilo-Labs, thermal hazards evaluation, process engineering (modeling, crystallization, particle engineering) and characterization platforms (DoE)
• Identify and drive life cycle management opportunities including cost of goods and plant cycle time reductions
• Promote a continual learning culture where our scientists and engineers relentlessly pursue innovation
• Introduce new development technologies, tools, and platforms to drive efficiency, capability, and speed
• Manage resource and budget planning, departmental objectives, prioritization, and project assignments
• Lead and/or influence interdisciplinary projects involving Analytical Development, Production, Quality, Regulatory, Finance, and the Business Units
• Apply experience with technical writing for regulatory dossiers (IND, NDA, ANDA, DMFs etc.) and to develop strategic responses to global Health Authorities
• Organize or participate in departmental committees to ensure that industry standards and best practices are applied
• Engage internal and external clients/partners to effectively communicate strategy, plans and timelines
• Lead and/or contribute to Technical Review Gate meetings and Phase Reviews to advance the portfolio
• Build & foster industry – academia collaborations to advance Veranova’s technology platforms and projects
• To take on any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
• The Director of Chemical Development will cultivate and grow a world-class process development team that is passionate about designing novel and efficient synthetic processes to manufacture active pharmaceutical ingredients.
• Key to success in this role will be the demonstration of strong leadership skills with the ability to quickly build credibility with the site leadership team and scientific staff.
• Support Veranova’s new product introduction (NPI) framework, including establishment of best practices for chemical development, authoring of guidance documents and leading staff training activities.
• Develop future leaders as well as technical subject matter experts. This will include recruiting, developing, and retaining top talent. Important aspects of this objective will be accomplished through mentorship and training of scientific staff, as well as designing improved process development platforms to drive speed, efficiency, and process knowledge.
• Demonstrate and promote external scientific eminence to enhance Veranova’s reputation within the industry via publications, patents, presentations and contributions to scientific conferences and industrial consortia.

Qualifications

• PhD in Chemistry (Organic Chemistry / Synthetic Chemistry) or Chemical Engineering
• 8+ years of academic, post-doctoral or pharmaceutical industry experience
• Extensive experience in drug substance process development
• Possesses ability to lead, coach and develop a team of multiple experience and skill levels. Exhibits an adaptive management style with an ability to positively resolve conflict
• Possesses the ability to write clear and concise technical reports, presentations, and business correspondence
• Strong business acumen
• Experience in working in a multi-disciplinary team environment
• Sound knowledge of current Good Manufacturing Practices (cGMP) and FDA guidelines
• Demonstrates strong analytical, written, and verbal communication skills
• Possesses the ability to write clear and concise technical reports, presentations, and business correspondence
• Demonstrated ability to successfully contribute across multiple scientific endeavors
• Proven track record of scientific excellence through presentations at conferences and publication of peer reviewed manuscripts
• Able to troubleshoot critical issues or problems using appropriate information and, determine causes and viable solutions
• Ability to work well on global cross-functional teams.
• Must be able to expresses oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
• Exercises good time management and prioritization skills to balance multiple project and departmental objectives
• Subject matter expertise in organic chemistry. Demonstrated ability to successfully contribute across multiple scientific endeavours
• Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
• Project management skills: ability to manage one’s time within individual, departmental, and corporate goals, and timelines; management of internal and external resources
• Demonstrated scientific eminence as evidenced by publication of peer-reviewed manuscripts, book chapters, presentation of scientific posters or lectures at professional conferences or events

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.