Associate Specialist, Engineering

Associate Specialist

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company's lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company's Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years, as well as future anticipated growth as part of the new product vaccine tech transfers to the facility.

The Process Support Lab at the Durham site is seeking an Associate Specialist with strong interpersonal, communication, and collaboration skills responsible for lab-scale vaccine process development execution, technical transfer support, and post commercial process enhancements activities for multiple pipeline vaccine programs. The well-qualified candidate must have analytical, problem-solving, and communication skills. Furthermore, the candidate will be required to work in a fast-paced environment.

Off-shift or weekend coverage may occasionally be required to support the technical team, based on project-specific assignments and/or the vaccine production schedule.

Key responsibilities may include but are not limited to:

• Provide technical hands-on support in execution of lab-scale experiments in at least one of the following areas: buffer/media preparation, cell/tissue culture, particle isolation, or product lyophilization.
• Execute bio-analytical assays for in-process and post-process samples (can include potency assays, metabolite analysis, moisture analysis, FTIR, SEM-EDS, UV/Vis, etc)
• Perform particle isolation, microscope imaging, and particulate analysis using analytical equipment to determine origin of particulate submissions with quick turnaround to support manufacturing investigations at the site.
• Assist in design and execution of lab experiments to support process characterization, commercial technology transfer, and qualification studies associated with the development and implementation of bulk processes, systems and facilities related to pipeline vaccine bulk products.
• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products (investigational and/or developmental studies).
• Troubleshoot equipment and assays as needed.
• Ability to support off-shift or weekend work if needed.
• Author and present experimental design proposals, technical reports and documents.
• Compile process data and employ statistical tools for experimental analysis and process monitoring.
• Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to vaccine processes.

Education Minimum Requirement:

• Bachelor's Degree or higher in Engineering or Sciences, with relevant academic experience with at least one (1) year of relevant experience.

Required

Experience and Skills:

• Strong leadership, interpersonal and communication skills (written and oral).

Preferred

Experience and Skills:

• Vaccine or biologics manufacturing within an aseptic, cGMP environment
• Hands-on experience in large molecule manufacturing or bio-analytical assays.
• Experience designing experiments and authoring technical documentation.
• Solves Technical Problems Independently
• Strong Attention to Detail
• Ability to foster collaborative work environment
• Demonstrated systematic problem-solving skills

Required Skills:

Adaptability, Applied Mathematics, Biochemical Assays, Cell Cultures, Cell Physiology, Chemical Engineering Fundamentals, Chemical Plant Operations, Data Analysis, Engineering Standards, Estimation and Planning, Fast-Paced Environments, Field Failure Analysis, Interpersonal Communication, Job Description s, Mammalian Cell Culture, Manufacturing Scale-Up, Oral Solid Dosage, Plan of Action and Milestones (POA&M), Primary Cell Culture, Problem Solving, Process Optimization, Professional Engineering, Site Supervision, Teamwork

Preferred

Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  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 veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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