Analytical Development Manager

Summary:

The Manager of Analytical Development will serve as a leader and expert in analytical development of test methods; providing strategic and scientific guidance and technical support to the team; colaborates cross functionally to achieve the company goals.

Key Responsibilities include but are not limited to:

• Act as a senior internal analytical leader and expert to support various projects from initiation to commercialization, provides technical support to facilitate method development and analytical validation
• Provide strategic direction and responsible for analytical development, implementing improvements in analytical methods and method transfer
• Responsible for safely and effectively developing, establishing, and validating analytical testing methodologies to control raw materials, production intermediates, and drug substances; ensure all analytical testing activities are in compliance with applicable compendia and FDA/ICH regulatory guidance.
• Develop/ update SOPs and quality assurance systemic documents for analytical development tasks; ensure all instruments are qualified to conduct analytical activities, meet requirements of GMP and appropriate regulatory guidelines.
• Responsible for multiple analytical project management, setting objectives, and prioritizing activities based on business requirements. Determining budget (equipment, facilities, headcount) requirements to meet organizational goals and balancing resources to ensure that business needs are met.
• Maintaining an awareness of developing trends and new opportunities to improve operating efficiency and reduce cost.
• Be responsible for on-time, on-budget delivery of analytical support.
• Responsible for routine analytical lab activities well-coordinated, analytical methods qualified and fit for purpose, and the information effectively communicated and documented in a timely manner.
• Act as a department leader to lead the team, including supervising, coaching, mentoring and developing team members.
• Identify and address technical and validation gaps in analytical methods and QC testing.
• Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity.
• Act as a partner with Manufacturing and Quality teams to ensure that appropriate analytical methods are developed, qualified, and put into use for routine QC testing and characterization of drug substances, starting materials, and in-process samples.
• Thorough knowledge of Good Manufacturing Practices. Acts as area owner for SOPs, change controls, deviations, and CAPAs (Corrective and preventive action).

Qualifications and Requirement

• Degree in Chemistry, Analytical Chemistry or related discipline, at least 5 years relevant experience in the pharmaceutical industry with a minimum 3 years of people leadership experience is required,
• In-depth theoretical and hands-on experience in various analytical techniques and instrumentations (HPLC, UPLC, HPLC-MS IC, GC, GC-MS, NMR, UV, AAS ) for analytical development.
• Solid track records in method development, method transfer, and validation for commercial manufacturing.
• Excellent verbal and written communication skills, ability to effectively work across levels, functions, and with external customers.
• Fluent in English
• Ability to work under pressure to meet deadlines.
• Self-motivated with the ability to work independently
• Working knowledge of Microsoft office and of software products including Excel, Word, and PowerPoint

Knowledge and Skills

• Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions.
• Ability to lead successfully within extended project teams and handle multiple challenges under pressure.
• Excellent communications and presentation skills - written and verbal; create and deliver summaries, development reports, and presentations as needs.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously.

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