We are looking for a Senior Manager - Microbiology with extensive background and expertise regarding the development, implementation, and maintenance of quality control microbiology systems and activities.
ESSENTIAL JOB FUNCTIONS:
- Drives performance and continuous improvement, while managing diligent execution of day-to-day performance.
- Is effective at root cause analysis and overseeing effective implementation actions.
- Manages all quality control microbiology activities and oversees hiring, training, and developing QC micro personnel.
- Establishes and communicates high performance standards through meaningful KPIs, defines clear accountability, and leads by adopting improvement strategies to reduce operational variances and increase efficiency.
- Creates and approves the validation process for new facilities and equipment.
- Manages departmental budget, headcount and capital.
- Sets short-term and long-term department goals and deploys goals to the department staff.
- Coordinates QC micro functions with operation activities and cross departmental staff for multiple sites and fill lines at Lusk and Roselle.
- Ensures implementation and maintenance of quality systems, including but not limited to SOP writing, deviations, trend reports, personnel training, ACT reports, CAPAs and Complaints.
- Interacts professionally with clients for process development, transfer, testing and monitoring activities. Represents the company as the subject matter experts (SME) for microbiological matters and addresses client inquiries.
- Demonstrates aptitude to influence clients, peers and leadership on critical compliance and business interfaces.
- Represents department in internal and external audits. Responsible for on-time resolution of audit deficiencies.
- Analyzes data and results and provides conclusions and proposals for final reports; capable of critical review.
- Performs investigations and makes for the corrective actions necessary to assure conformity with quality specifications.
- Oversees staff competency and /or training in all aspects of testing, cGMPs, SOPs (standard operating procedures), company policies and safety.
- Ensures compliance activities are performed on time.
- Builds effective partnerships with department heads to help drive the business toward achieving company objectives.
- Regular and reliable attendance on a full-time basis or in accordance with posted schedule.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in a Life Sciences discipline or equivalent experience required. Minimum of seven (7) years relevant experience in Quality Control Microbiology. Minimum of three (3) years of supervisory experience.
- Significant experience with GMP, USP, EM, contamination control, aseptic techniques and troubleshooting.
- Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork.
- Detail oriented with strong written, verbal communication and presentation skills.
- Proficiency with Microsoft Office applications.
- Directs and provides expert knowledge in the day-to-day function of Microbiology.
- Identifies, recruits, and retains top-notch talent.
- Champions the company culture and empowers employees to take responsibility for their jobs and goals.
- Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
- Provides oversight and direction to the employees in accordance with the company policies and procedures.