Senior Manager of Microbiology - CDMO

Posted 21 February 2024
Salary Negotiable
LocationUnited States of America
Job type Full Time
Discipline Large Molecule
Contact NameChristopher Gomez

Job description

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

Senior Manager of Microbiology - Responsibilities:

  • 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:

  • 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 +1 (786) 485 1298.