Laboratory Manager

job summary :

The Lab Manager is responsible for a large variety of operational tasks that support laboratory and facility operations. In this role, you will assist with purchasing, inventory management, lab maintenance, and administration of the computerized maintenance management system.

Additionally, the Lab Manager will work within a quality system to process deviations, change control, SOPs, and CAPAs. The successful candidate will work closely with CMC and Facility personnel to ensure the facility and equipment is kept in an inspection ready condition.

responsibilities :

Assist in the implementation and administration of the computerized maintenance management system, including creation of maintenance work instructions, updating asset records, tracking record approvals, ensuring timely closure of work requests, work orders, and asset requests.

Assist with completion of the CMMS implementation, including participating in the performance qualification.

Assist with process equipment maintenance in the MS&T and QC labs. Supervise the activities of maintenance service technicians.

Ensure documentation is completed at the time of service and that work is performed in accordance with EHS / GMP requirements.

Effectively align maintenance activities with stakeholder schedules to ensure the maintenance without disrupting the MS&T and QC schedules.

Assist with the identification of critical spare parts and stand-by equipment needed to assure maximum capacity and reliability.

Assist with ensuring appropriate vendor service contracts are in place to support the maintenance program including timely raising of new / modified service contracts and issuance of POs.

Perform all activities in compliance with applicable cGMP regulations, FDA, USP and ISPE guidelines. Organize and clearly document maintenance records in accordance with GDP Participate in and / or initiate GMP investigations, deviations, CAPA, and change control related to maintenance.

Champion GMP compliance and maintenance best practices to support a best-in-class maintenance program. Identify and recommend initiatives for continuous improvement, including developing or modifying SOPs.

• Perform regular inspections of the QC and MS&T labs to identify areas of concern, initiate work orders, schedule repairs and track to completion.
• Assist building support services including office and kitchen inventory, access card issuance and seating planning.

qualifications : Required

Required

• Bachelor’s degree or relevant experience.
• Requires 2+ years of relevant experience within a laboratory environment.
• Demonstrated oversight, knowledge and experience with computerized maintenance management systems.
• 5 days a week in office situation (not a work from home role)
• A work-ethic focused on precision and accuracy.
• Excellent communication skills with a proven track record of working in a collaborative and team environment.
• Solid analytical and critical thinking skills
• Excellent partnering skills able to collaborate with technical and non-technical staff across the organization.
• High energy, confident, gets things done.
• Experienced with GMP Quality Management system (deviations, CAPA’s, etc.).
• Strong ability to analyze raw data, assess results and determine appropriate action.
• Ability to consistently apply work methods with precision and accuracy to ensure quality results.
• Must have strong organization skills and a resilient mentality to be able to rapidly adjust and accommodate conflicting priorities and sudden scheduling changes.
• Capable of successfully working independently with limited supervision as well as in a collaborative environment.

Desired

• GMP experience in a pharmaceutical environment
• Project management skills
• Highly collaborative and supportive of business and of its ideals and strategies
• Prior experience in complex biotechnology and / or pharmaceuticals industry

skills :

CAPA, GMP (Good Manufacturing Practice)