Objectives:

The AS&T (Analytical Sciences & Technology) Associate Director will provide the leadership, development and implementation of analytical controls activities including both analytical science and quality control across Hilleman Laboratories’ R&D/CMC development operations and clinical GMP manufacturing processes. The incumbent supports Analytical Development team in R&D/CMC to define the analytical methods and requirements for process development to pave the path to IND submission, and leads the subsequent analytical method transfer for GMP product manufacturing process in GMP function. To ensure that qualification and transfer activities are planned and executed to support the manufacturing of vaccine and biologics products in an efficient, effective and compliance manner. This incumbent is also responsible to ensure the overall QC laboratory operations, QC related systems/processes compliance, consistencies and robustness in accordance with applicable regulatory requirements and to drive proactiveness and continuous improvement efforts. Ensures quality, safety and compliance of Hilleman Laboratories developed and manufactured products for disposition. As a key member of the Quality Leadership Team and he/ she will partner with cross functional teams to achieve the business's operational goals/objectives.

Responsibilities:

• Work with Analytical Development team to establish the strategy and approach for analytical method life-cycle management including control of method development, characterization, performance, pharmacopoeia and health authority compliance and definition of method improvements.
• Accountable for leading and providing strategic directions in the overall AS&T & QC related systems/processes, programs and procedures.
• Collaborate with process development, analytical development, technical services, manufacturing, supply chain, quality assurance and regulatory affairs for scientific analytical support.
• Manage and coordinate analytical control activities at external laboratories. Support for trouble shooting activities and continuous improvement initiatives.
• Oversee QC laboratory operations to ensure compliance with GMP and internal quality standards through direction, authoring, reviewing and approving standard operating procedures (SOPs) for all analytical control activities.
• Review and approve analytical control documents e.g., analytical protocols and reports, registration documents, SOPs & etc. Support overall regulatory / program sponsor interaction and documentation.
• Monitors the overall health and performance of the entire AS&T & QC related programs to ensure systems’ robustness and identify opportunities to support continuous improvements efforts.
• Handle laboratory events, deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints. As a person of contact for analytical questions from health authorities and analytical subject matter expert during audits and inspections.
• Manage and oversee product stability and analytical studies for programs. This includes authoring/reviewing protocols and reports as well as evaluating the results e.g., trending and leading technical discussions with technical expert and program sponsor.
• Lead and develop strategies/playbooks for Analytical Sciences and QC related topics to support and ensure the success of regulatory inspections and site audits.
• Provide leadership and guidance to AS&T team. Mentor, develop and inspire AS&T staff of all skill levels to excel and reach their potential technically, professionally and compliantly.
• As member of the Quality Leadership Team (QLT) responsible for setting AS&T related strategies and quality standards.

Education, Behavioural Competencies And Skills:

Basic Qualifications:

• Bachelor’s degree or equivalent, preferably in science, engineering or other related technical field.
• Minimum of 10-15 years of relevant experiences, preferably in Analytical Sciences, Quality Control, CMC or related field in the pharmaceutical industry (preferably vaccines or biologics industry).
• Familiar with regulatory requirements and local Codes & Standards especially in vaccines and biologics e.g., FDA, EMEA and ICHQ7

Preferred Key Skills, Abilities, and Competencies:

• The role should possess in depth knowledge of the relevant regulatory environment, including applicable regulations and current guidelines for analytical sciences supporting process characterization as well as strong knowledge and understanding of microbiology, analytical testing, QC systems and contamination control strategy.
• In-depth knowledge and experiences with GMP laboratory operations, data integrity requirements and associated laboratory equipment.
• Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
• Proficient in Quality Management and Quality Risk Management principles
• Strong leadership capability to lead a highly diverse team.
• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and external stakeholders.
• Experience in working with internal and external multifunctional teams.
• Problem solving skills with ability to apply logical, science-based thinking to reach quality decisions/solutions that are compliant and ensure product quality.