Mantell Associates
Mantell Associates is partnered with a CDMO who is seeking a highly skilled and experienced Director of Microbiology.
Director of Microbiology – Responsibilities:
- Leadership of Drug Product function
- 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
- 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
- Embodies cultural values and aligns daily actions with department goals and company culture
Director of Microbiology – Requirements:
- Experience in Drug Product
- Strong leadership skills
- Bachelor’s degree in a Life Sciences discipline or equivalent experience required
- Minimum of 7 years relevant experience in Quality Control Microbiology
- Minimum of 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
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.