Spclst, Operations

Job Description

Job Description:

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, manufacturing plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of Vaccines and Biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, warehouse, utilities, and quality control laboratories.

The Specialist, Operations will be responsible for providing support to the manufacturing area as part of the Operations team.

This is a full-time position working Monday through Friday, dayshift (normally 8:00am-4:30pm)

Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire, blood test, chest x-ray

Position Responsibilities:

• This role reports to an Operations Associate Director and supports the product transfer for a new facility in Durham, NC within Drug Substance, Drug Product and/or supporting areas.

• Support and execute to approach for production team as part of tech transfer and modernization for process

• Collaborate with broad partners and stakeholders across MPS, GES, and across site for information

• Independently manage project assignments, escalate potential delays and develop remediation plans when applicable

• Collaborating across diverse teams

• Creating strong safety culture

• Contributing to the manufacturing team and support for the facility

• Leading routine process support, projects, and improvement activities

• Serving as subject matter expert on the process for daily work and projects, understand full process requirements such as safety, compliance, process

• Providing guidance for daily production support, projects, deviations and changes

Required Experience and Skills:

• Bachelor’s degree in an Engineering or Science related field with minimum of 2 years post-degree experience in manufacturing, operations, pharma, biotech or vaccines work environment

• Communication, leadership and teamwork skills

Preferred Experience and Skills:

• cGMP experience in a sterile bulk, biologics or pharmaceutical environment, operations, technical services, supply chain, and/or quality operations

• Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and/or supporting clean utilities

• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately

• Flexibility and ability to manage multiple priorities

• Demonstrates interpersonal, technical aptitude and problem-solving skills

• Experience using Lean, Six Sigma, Operational Excellence tools

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Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected