Associate Director, S&T Microbiology
The Associate Director position within the Science and Technology organization is responsible for providing the technical leadership, direction and management of the S&T microbiology team to support parenteral and oral drug products. The Associate Director will provide the technical expertise for commercial manufacturing during development of new products, manage operation and commercial timelines, and execute budgets for global projects and the team. The Associate Director establishes goals that are consistent with the department, development, manufacturing and customer requirements, implements plans and policies, assigns duties and responsibilities and controls subordinates performance to meet the goals and commitments.
- The Associate Director provides technical leadership for sterility process assurance and microbial control for parenteral and oral drug products as required to assure compliance with cGMP and regulatory requirements.
- Provide direction in method validations, sterilization, SOP's, tech transfers, raw material controls to support drug products.
- Lead and support investigations for microbial contamination events and establish root cause and CAPA.
- Direct team in the justification of microbial controls and limits for API's, parenteral and oral drug products.
- Drive implementation of new technologies related to microbial monitoring and controls
- Responsible for implementation of global projects across Abbvie plants and marketed affiliates including Abbvie plants and products manufactured at Third Party Manufacturers (TPMs)
- The Associate Director provides technical expertise for marketed products and can represent the company in discussions with regulatory agencies. Also provides support for regulatory audits and filings. Due to the nature of the projects and support of marketed products, the impact of decisions are significant to AbbVie's pharmaceutical Operations to minimize back orders and regulatory risks.
- The scope of activities for the teams includes interactions with R&D, Operations, Quality, Commercial and regulatory as well as the relevant technical plant support functions both within Abbvie and at third party manufacturers.
- The Associate Director is responsible for the management of a technical team of scientists and technicians ranging from scientists to senior level scientist. The group is responsible for providing technical expertise for all regulatory and quality documentation as well as post-approval filings.
- The global nature of the job requires the position to have an excellent knowledge of the various regulatory and GMP requirements as well as outstanding communication skills. The position requires interaction with scientists from various sites and at times frequent traveling to support the projects.
- BSc degree in scientific or technical field preferably in Microbiology. Masters Degree and/or PhD is preferred.
- Ten (10)+years in the Pharmaceutical Industry with at least 5 years working in relevant support group is required. Experience in support of marketed products is preferred.
- The Associate Director must display managerial ability via leadership, supervisory experience and administration.
- Exhibits a thorough understanding of Global CMC drug development, strong management skills, financial, research management practices and long term planning skills.
- Excellent knowledge of various international regulatory and GMP requirements
- Must be goal oriented, able to work within a team environment, self-motivated and understand the business needs to meet timelines
- Good verbal, written communication skills and the ability to interface with multiple areas with the organization is essential.
- Previous experience in supervising people is preferred.