Manager Laboratory Operations

Germer International - Pharmaceutical Recruiting; Center Square (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting has partnered with a global biotherapeutics organization to recruit a Manager, Lab Operations. The role ensures daily operation, facility readiness, and GMP compliance for Quality Control labs, coordinating with cross-functional partners to secure safety, training, and timely closure of quality events.

The ideal candidate brings a scientific background, 7+ years in pharma, and leadership experience to drive continuous improvement in analytical

Qualifications

• Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred.
• 7 years of related pharmaceutical experience in a GMP environment.
• Advanced formal training, degree or certification(s) preferred.
• Proven ability to work well under pressure and adapt quickly to change.
• Competitive base salary and annual bonus.

Responsibilities

• Provide scientific and technical guidance in flow cytometry, molecular, microbiology, and analytical capabilities.
• Lead lab operations and coordinate with internal/external partners for tasks and documentation.
• Support GMP testing operations.
• Perform and manage analytical system validation and release.
• Conduct investigations for cell and gene therapy programs.
• Maintain awareness of GMP/GTP regulations applicable to operations.
• Open, investigate, and close deviations, change controls, CAPAs and other quality events.
• Oversee the daily workflow of the department.

Skills

Leadership

Communication

Cross-functional coordination

Problem solving

Education

Bachelor's degree in science or engineering

Master's degree preferred

Job description

Organization is a leading development and manufacturer of targeted biologic therapies for patients globally. With over 1,000 employees throughout the world and multiple locations they can deliver pharmaceutical clients programs from molecule to commercialization.

Manager, Lab Operations

is accountable for the daily operational, facility readiness, and compliance of Quality control laboratories. The manager will also coordinate cross functional efforts between the lab operations group and other supporting departments to ensure laboratory safety, vendor management, material availability, facility and equipment maintenance, on time closure of quality events, and end-user training. This individual also acts as the validation system owner for scientific equipment and will work with group leads for necessary development/qualification activities. The position requires superior leadership, scientific experience, and the ability to clearly communicate with the internal department and external department.

Responsibilities:

• Provide scientific and technical guidanceand serve as the subjectmatter expert (SME) including but not limited to flow cytometry, molecular, microbiology, and analytical capabilities.
• Lead lab operations with respect to coordination with internal and external partners for tasks such as work orders, equipment or facility projects, material/waste workstreams, and revisions to operational procedural documentation.
• Support GMP TestingOperations.
• Perform and manage analytical systemvalidation and release.
• Conduct technical and laboratory investigations for multiple cell and gene therapy programs.
• Advance scientific understanding of gene therapyproducts and analytical techniques.
• Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards, and trends that are applicable to current and future cell and gene therapy development operations and products.
• Open, investigate, and close deviations, change controls, CAPAs and other quality events.
• Oversee the daily workflow of the department.

Qualifications:

• Bachelor’s degree in a scientific or engineering discipline required; Master’s degreepreferred.
• 7 years of relatedpharmaceutical experience required,including relevant experience in manufacturing in a GMP environment.
• Advanced formal training,degree or certification(s) preferred.
• Proven ability to work well under pressureand adapt quicklyto change.
• Competitive base salary and annual bonus