Provide scientific support and technical expertise to the QC Microbiology laboratory department as well as other functional areas within the organization to ensure quality, compliance and efficiency in QC laboratory performance.
Key Responsibilities/Essential Functions
Validate microbiological methods (lead or assist with modifications), evaluate new materials/products, establish testing standards and troubleshoot complex issues in the QC Laboratory.
Support aseptic manufacturing process validations: including facilities, utilities, process equipment, and product qualification, ensuring all required deliverables meet internal requirements and applicable regulatory standards.
Lead, write, and execute protocols/reports for procedural and instrumentation validations.
Perform LEA (lab equipment assessments) and QVAs (quality validation assessments).
Perform non-routine/advanced lab testing in accordance with SOPs and cGMP guidelines. Perform verification and approval of data to ensure accuracy.
Responsible for oversight of calibration and maintenance for QC laboratory equipment, as assigned.
Where necessary, develop the required skills within the QC Microbiology team, including the training of existing personnel.
Lead or participate in training of Manufacturing and QC personnel in aseptic technique and aseptic processes. Perform periodic assessment of aseptic technique and processes.
Assist Laboratory Management with inspection readiness activities and serve as a QC Microbiology SME during regulatory inspections.
Identify and lead continuous improvement efforts.
Perform Administrative functions for QC Laboratory electronic systems, including LIMS, NOVATEK and other document/equipment management software platforms.
Author, review and act as document owner for SOP changes; take lead on change controls, CAPAs and other quality system requirements.
Represent Quality Control Microbiology in cross functional team meetings and projects, providing technical perspective and expertise.
Maintain and increase personal scientific, regulatory and compendial expertise, and contribute to team objectives. Extensive knowledge of industry practices in the area of microbiology. Applies extensive technical expertise, and has full knowledge of other related disciplines.
Applies advanced knowledge of scientific methods to resolve routine and advanced problems. Contributes technical expertise to investigations, resolution, and documentation of laboratory issues. Develops technical solutions to complex problems which require the regular use of ingenuity and creativity. Provide technical skills to support/lead investigations.
Guides the successful completion of major programs and may function in a project leadership role. Demonstrates flexibility to handle changing priorities without impact to other projects.
Team player who can work independently with minimal direction with high attention to quality. Strong communication skills both oral and written. Solid interpersonal skills, ability to take a lead role and interact with a diverse group of individuals at various levels (including key-stake holders, inter-organizational and outside contacts such as CMO representatives). Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Ensures all functional activities are conducted in compliance with, the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
Actively promote safety rules and awareness. Demonstrate good safety practices at all times including appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards through partnership with Environment Health and Safety resources.
Promote and demonstrate the values of Accountability, Collaboration, Customer Service, Efficiency, Quality and Safety. Demonstrate appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
* In the case of absence, reports to Manager above or a peer incumbent will function as a backup for this position.
Aseptic manufacturing experience, including familiarity with technical support of aseptic manufacturing process technologies and facilities. Experience with Isolator based aseptic fill/finish manufacturing preferred.
Subject matter expertise in Microbiology.
Lean experience and training preferred.
Typically requires 8+ years with a BS in a related scientific discipline (6+ years with an MS, or 4+ years with a PhD) of previous microbiology experience in the pharmaceutical industry, related GMP environment, or equivalent combination of education and experience; Advanced degree preferred.
Experienced in analyzing data and developing technical reports to support project plans; including presentation to senior leadership.
Some non-routine travel may be required.
Flexibility with scheduling requirements-may include extended shifts, overtime, weekends and holiday coverage; including during adverse weather conditions.