Mantell Associates is partnered with a CDMO who is seeking a highly skilled and experienced Director of Microbiology.

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Senior Manager 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

Senior Manager 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

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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.