As an Operations Director for Manufacturing and Client Cell Culture, you will oversee the daily management of multiple laboratories conducting GMP and non-GMP cell bank manufacturing and other cell expansion activities. This includes supervision of managers, supervisors, scientists, associate scientists, and/or lab technicians in each lab. This also includes oversight and accountability for quality of work, service delivery, financial targets, and other established lab performance targets. You are responsible for the scientific integrity of technical work performed, adherence to all regulations, and are required to ensure scientific observations, detailed workbooks and all other documentation fulfills generally accepted (cGMP and cGDP) professional/industry standards. You will manage and lead cell bank manufacturing and cell expansion for subsequent characterization testing in compliance to cGMP for multiple laboratories within our Biologics business. Less than 10% travel required for this role.
Additional responsibilities include:
Oversee the development of manufacturing technical specifications with client input.
Make final decisions on operational matters to ensure achievement of department objectives.
Effectively deploy the resources within the laboratory and make recommendations to Head of Biologics Operations for required additional resources to facilitate the continued expansion of the business.
Drive teams to meet revenue targets while maintaining and controlling associated budgeted expense lines.
Drive business and quality metrics to meet company goals: on time delivery, right first time, repeat rate, etc.
Interact with Sales/Marketing to develop and implement the business of the company and provide support to the sales team where required.
Interact with other operational leaders and senior management in the organization to promote synergies between departments and more effectively utilize resources.
Interact with global colleagues to ensure uniformity of standards and service within the company as well as drive global alignment.
Liaise with the Operational Excellence and Digitalization & Automation project leads on continuous improvement efforts. Coordinate resources needed for such projects.
Who you are:
BA/BS in scientific discipline
5+ years experience leading small to mid-scale biologics manufacturing operations (e.g. cell bank manufacturing)
5+ years experience with cGMP regulations and regulatory compliance.
5+ years of previous people management experience
Working knowledge of spreadsheets and spreadsheet data analysis tools.
Effective coaching and developmental skills for direct reports.
MA/MS in scientific discipline.
Excellent time management and organization skills.
Excellent oral and written communication skills, both formal and informal that have been demonstrated through presentations/seminars, oversight of projects, etc.
Job Requisition ID: 205589
Career Level: D - Professional (4-9 years)
Working time model: full-time
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North America Disclosure
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