Director, QC Microbiology, CTDO Quality Control

• Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.

• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.

• Ability to collaborate cross functionally to drive operational and quality excellence.

• Advanced organizational and time management skills.

• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.

• Advanced teamwork and facilitation skills.

• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.

• Requires strategic thinking and ability to work independently.

• Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.

• Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.

• Ability to interpret and author general, technical, and complex business documents.

• Advanced knowledge and implementation of data integrity principles.

• Ability to represent the department in regulatory inspections.

• Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.

• Proficiency in MS Office applications.

• Ability to develop and manage a departmental budget.

• Ability to manage headcounts.

• Ability to lead projects to completion.

• Ability to design microbiology laboratory space and drive lean lab initiatives.

• Knowledgeable about micro assays including endotoxin, mycoplasma, rapid sterility method, automated EM plate reads

• Bachelor's degree required, preferable in Chemistry, Microbiology, or related s cience.

• Advanced d egree preferred.

• 10 y e ars o f relevant work experience required. Higher education may be counted towards work experience.

• Leadership experience with direct reports required.

Manages all activities related to the Quality Control Microbiology department including:

• Stability testing

• Raw material, in-process, and final product testing

• Environmental Monitoring

• Method validations/maintenance

• Metrics/data analysis

• Investigations

Manages and develops direct reports including:

• Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.

• Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.

Performs other tasks as assigned.

Th e incum bent will be required to work in office and laborato r y environments.

• T he incumbent may be required to gown for entry into the Aseptic C ore and other supporting areas on an a s- needed basis.

• The incumbent (or designee) will be expected to be on call to support issues in v olving test excursions or q u estions during shift operation s .

• Occasional travel may be required.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.