Vice President, Analytical Services

Our Client is a CRO providing integrated, scientifically-driven research, analytical and development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. The company has enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance.  The company has successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets.

The Vice President, Analytical Services reports to the CEO and has responsibility for leading the Analytical Services group – managing the establishment and deployment of the company’s analytical expertise, infrastructure, and operational systems necessary to support the client’s product development strategy and activities.

This customer-facing role functions to grow the company’s demand for Analytical Services In this capacity the role will manage a team of Service Managers and Project Managers to provide strong technical, scientific, and administrative value to customers in the areas of analytical testing design, development, and validation.

The job responsibilities for the position shall include but not limited to the following:

• Develop, present and close client proposals for analytical support of product development, manufacturing process design, optimization, validation, transfer, and commercialization.
• Collaborate internally and with client resources in formulation development, regulatory affairs and quality group to define drug product quality attributes, testing methods, stability profiles, product performance attributes, and release & in-process specifications.
• Serve as subject matter expert (SME) to lead establishment of internal SOPs for the analytical operations, implement relevant industry best practices and regulatory guidance, and ensure compliance of analytical operation that can satisfy all audits from regulatory bodies and clients.
• Enhance and positively contribute to analytical inputs as required by QC team for client testing and manufacturing sites
• Ensure write up and review the technical reports at different stage of developmental activities.
• Responsible for matters such as maintaining quality, accuracy and quantity of work; providing advice, guidance and direction; dealing with routine problems; developing detailed internal work methods; and initiating recommendations on personnel matters.
• Oversee and collaborate with internal/external partners involved with formulation/process development, bioequivalence studies, regulatory, manufacturing, and marketing.
• Update management on important issues and escalate potential critical issues in a timely manner.
• Provide strategic direction for outsourcing analytical development and methods to another laboratory wherever required. Select and manage CMOs/CROs to execute pharmaceutical development, analytical development and manufacturing activities.
• Responsible for providing inputs for annual budgets for analytical operations.
• Design and deploy effective training and skill enhancement curriculum and ensure professional performance and productivity for the analytical staff.
• Responsible for performance monitoring and appraisal for subordinates.

Required Education, Capabilities, Experience and Competences

• D. in analytical chemistry, pharmaceutical chemistry or related scientific discipline, with approximately 10 years of experience, OR Masters in analytical chemistry, pharmaceutical chemistry or related scientific discipline with about 15 years of experience, in analytical development area.
• Prior experience in a contract service provider, CDO, CMO, CDMO, is a plus.
• Demonstrated scientific knowledge and experience in analytical science in drug product development and associated analytical requirements throughout the development & commercial continuum.
• Demonstrated broad knowledge and experiences in the development and validation of test methods for small molecule API and drug product candidates, physical and chemical characterizations, general analytical analysis, assay/impurity analysis, dissolution testing, and specification development.
• Established knowledge of applicable global drug development and regulatory standards and current expectations. Knowledge and application of cGMP/GLP, ICH, FDA CMC guidance documents.
• Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters.
• Experience in technology transfer of test methods to external manufacturing sites and external CMOs.
• Excellent communication skills (oral, written and presentation) with global clients and colleagues.