Associate Director - Small Molecule Technical Services & Manufacturing Science, API External Manufacturing

Eli Lilly Benelux

Cork, Ireland

Responsibilities:

The Associate Director – Technical Services/Manufacturing Science (TSMS) API External Manufacturing is responsible for managing the activities of TSMS personnel supporting the oversight of externally manufactured Small Molecules. The Associate Director TSMS must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization and process optimization. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and multiple global suppliers to deliver on technical objectives, specific product business plan, and quality objectives.

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.

Basic Qualifications:

Bachelor’s Degree in scientific disciplines of Chemistry, Pharmacy, Engineering or other related field.
Prefer 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.

Additional Skills/Preferences:

Responsible for maintaining a safe work environment
Ability to influence and lead diverse groups
Influences complex regulatory, business, or technical issues within the site and function
Experience in statistics
Technical leadership, administrative and organizational skills
Builds 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 & apply technical/scientific knowledge