Thermo Fisher Scientific Sr Director, PDS Operations in Greenville, North Carolina
The Sr. Director, Pharmaceutical Development Services (PDS) Operations is an entrepreneurial site leader for building and sustaining Sterile Drug Product PDS Operations at our largest Drug Product manufacturing facility in Greenville NC. The Sr. Direction skillfully develops the service offerings and effectively delivers PDS services to customers. The Sr. Director drives effective and profitable management, advances the Patheon strategic vision as it relates to the local operation, and shares broadly across the PDS network. This role actively participates as a member of the site leadership team defining growth and talent strategy for this emerging division and building internal and external partnerships to assure a stable pipeline of products in development. Reporting to this leader are highly skilled Analytical scientists with expertise in Chemistry, Biochemistry, Immunology, and specifically those with expertise in Sterile Liquids/Lyophilized products, small and/or large molecule method development and method validation. In our Pharmaceutics & Process Technology (PPT) group which also reports to this leader, scientist and leaders of this group will have educational background in Steriles Pharmaceutics, Industrial Pharmacology, or advanced level scientific background in Chemistry or Biology with a focus on lyophilization, technical transfer and process scale-up projects, aseptic, parenteral, liposome, nanoparticles and tangential flow filtration.
Manages and delivers signed work to customers with a high degree of RFT and OTD delivery and actively keeps Net Promoter Scores (NPS) scores high, expanding projects and growing work with existing customers. Recommends strategies to enable growth of site.
Drives Patheon’s operational efficiency initiatives, and leads change throughout the site.
Actively supports sales in bringing new clients to the site; an expert on all site capabilities.
Maintains knowledge of competitive landscape in the CMO industry.
Active participant in site leadership team developing strategic objectives. Cascades through direct reports.
Plans and utilizes available resources effectively in order to achieve business objectives.
Establishes a strategic overview with regard to continuous improvement in GMP, business and management processes. Establishes and maintains robust quality systems to support the analytical, formulation, manufacturing and business activities within PDS, and between PDS and Drug Product (Manufacturing).
Maintains state of readiness for, and actively participates in client and regulatory audits.
Forecasts and maintains departmental budgets, provides monthly status and compliance report outs to site Vice President / General Manager and other functional heads.
Reviews project performance, identifies issues and areas for improvement, and complies with all corporate and site Quality and EH&S standards.
Leadership of people to implement change, understand consequences and obtain commitment through coaching, training, and clear objective setting to meet the site’s short term needs and long term ambition.
Develop department members to be key leaders within the organization. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
Builds pipeline of future talent to enable growth; and retain top talent on behalf of Thermo Fisher Scientific.
Helps set strategic business direction for PDS business in collaboration with site and corporate leadership.
Selects, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.
Bachelors of Science degree, Masters or PhD in directly related technical field required Chemistry/Biochemistry, Chemical Engineering)
12+ years management experience within a Sterile Fill Drug Product operational environment
Strong business management knowledge and experience
Demonstrated track record of multi-discipline leadership
The ability to operate in a culture of high scrutiny and to leverage corporate resources for benefit of the business and site – ability to build and sustain relationships in a highly matrixed environment
Understanding of the development processes and associated Regulatory requirements
Excellent interpersonal skills used to work and communicate with staff at all levels and to interactive positively/sensitively with our clients
Decision maker who drives initiatives to completion
Experience evaluating and understanding new development and formulation technologies
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.