TEMP GMP Lab Ops Lead

Seeking a highly motivated and experienced GMP Lab Ops Lead to support our expanding Quality Control team. In this role the candidate will use their exceptional organizational skills to support all activities and will assume a large variety of operational tasks. The ideal candidate must have experience in the following areas: purchasing, maintaining an adequate inventory of research consumables/ raw materials, handling of hazardous materials according to EH&S guidelines, maintaining basic laboratory instruments, SOP writing, record keeping and adherence to all regulatory requirements.

 

Responsibilities including, but not limited to :

 

• Manage existing and/or developing new systems/processes to improve laboratory operations and manage vendor relationships.


• Manage the storage and cataloging of samples, document protocols and collaborate with the lab leaders and other departments.


• Work directly with lab members and Unity lab services to maintain lab consumables and raw material that includes tagging, restocking stock room and POUs.





 
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Develop expertise in all primary job functions, enabling the ability to train others and update SOPs as required.

 

Support suite equipment and systems to ensure no disruptions to production.

 

Individual must be able to gown to meet cGMP or safety requirements (e.g., aseptic gowning or live virus/BSL-2 gowning).

 

As required collaborate with team members to ensure completion of all Compliance Operations tasks. This may include but is not limited to the following: processing sample requests, supplier qualification, and raw material testing.

 

Collaboration with QC operation team in sample management and coordinate delivery to 3 ^rd party and CMOs/ CROs.

 

Partner with Quality, Validation, and Facilities personnel to continually drive compliance and department deliverables.

 

• Assist in maintaining the asset management database and play an important role


• Inventory and maintain biological/chemical registrations and inventories.


• Maintain laboratory SharePoint website, laboratory software/licenses, data storage, and workstations, ensuring appropriate record-keeping.

 

 

 

Technical Requirements & Skills:

 

BS in scientific or other relevant discipline

 

Minimum 3-5 years of direct GMP experience in managing biomedical research laboratory operations

Experience in using and troubleshooting basic laboratory instrumentation

 

Knowledge of Blue Mountain CMMS, Veeva and Oracle workflows for laboratory operations

 

Cell culture knowledge and experience

 

Experience with remote, global lab facilitation and the researching and implementation of international laboratory requirements

 

Microsoft Office skills and be familiar with third-party management of software and IT infrastructure

 

Strong attention to detail, problem-solving, time-management and organizational skills along with the ability to balance multiple objectives

 

Willingness to collaborate with cross-departmental teams to improve scientific operational efficiencies and logistics, and to support business needs and scientific teams

 

Clarify Direction & Priorities : Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.

 

Partner & Collaborate Effectively : Listen to and value others thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.

 

Support Learning & Growth : Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.