Senior Technical Manager

As a leader in the pharmaceutical industry, we are seeking an experienced professional to fill the role of Associate Director – Technical Services/Manufacturing Science (TSMS). This individual will be responsible for managing the activities of TSMS personnel supporting the oversight of externally manufactured Small Molecules.

The ideal candidate will have a strong background in technical leadership and management, with experience in pharmaceutical manufacturing environments. They will possess excellent communication and interpersonal skills, as well as the ability to influence and lead diverse groups.

This role requires a deep understanding of cGMPs, regulatory guidelines, and industry standards for validation. The successful candidate will have a proven track record of delivering technical objectives, product business plans, and quality objectives.

Key Responsibilities:

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• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.\
• Performance management and development of technical staff.\
• Partner within TSMS and other functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.\
• Interact with suppliers, regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.\
• Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.\
• Ensure adequate oversight and technical excellence for investigations and complaints.\
• Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality.\
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.\
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.\
• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.\
• Collaborate with cross-functional teams to drive business outcomes and achieve operational excellence.\
• Develop and maintain relationships with internal and external partners to ensure seamless execution of projects and initiatives.\
• Stay up-to-date with industry trends, regulations, and best practices to ensure compliance and competitiveness.\
• Lead by example, demonstrating a commitment to safety, quality, and excellence in all aspects of the job.\
• Maintain accurate records and reports to ensure transparency and accountability.\
• Support and contribute to the development of training programs and materials to enhance the skills and knowledge of technical staff.\
• Participate in regular meetings and updates to ensure effective communication and collaboration across departments.\
• Provide input and guidance to project managers on technical requirements and resource allocation.\
• Identify and mitigate risks associated with technical projects and initiatives.\
• Develop and implement processes and procedures to optimize efficiency and effectiveness.\
• Manage budgets and resources effectively to achieve business objectives.\
• Monitor and report on key performance indicators (KPIs) to measure success and areas for improvement.\
• Perform other duties as assigned or required.\\/ul\

Required Skills and Qualifications:

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• Bachelor's Degree in scientific disciplines of Chemistry, Pharmacy, Engineering or other related field.\
• At least five years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.\
• Strong technical leadership and management skills, with experience in leading cross-functional teams and influencing organizational outcomes.\
• Excellent communication and interpersonal skills, with the ability to influence and lead diverse groups.\
• Proven track record of delivering technical objectives, product business plans, and quality objectives.\
• Deep understanding of cGMPs, regulatory guidelines, and industry standards for validation.\
• Experience in statistics and data analysis.\
• Technical leadership, administrative and organizational skills.\
• Ability to build relationships with internal and external customers and partners.\
• Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.\
• Demonstrated Project Management skills and ability to coordinate complex projects.\
• Strong analytical and quantitative problem-solving skills.\
• Ability to communicate and influence effectively across functional groups and stakeholders.\
• Strategic thinking and ability to balance short-term needs with long-term business evolution.\
• Enthusiasm for changes, team spirit, and flexibility.\
• Demonstrated ability to learn and apply technical/scientific knowledge.\\/ul\

Benefits:

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• Competitive salary and benefits package.\
• Opportunities for career growth and professional development.\
• Collaborative and dynamic work environment.\
• Recognition and rewards for outstanding performance.\\/ul\

Others:

10–20% travel may be required. Some off-shift work (night/weekend) may be required to support 24/7 operations across global supplier network.