Senior Specialist, Engineering

Job Description

Seeking candidates for a Senior Specialist position within our company's research laboratories Biologics Pilot Plant Process Operations Team. This individual will provide downstream technical guidance on pilot-scale campaigns for the Good Manufacturing Practice manufacture of bulk clinical supplies, leading technical process fit on downstream unit operations, and contributing to manufacturing activities in the other disciplines as needed. Strong comprehension of regulatory guidelines governing Good Manufacturing Practice manufacture is essential. The candidate will work in matrixed teams in close partnership with process and analytical development groups, facility engineering, Quality, Good Manufacturing Practice compliance, and safety groups. Candidate will participate in a range of process readiness activities including, but not limited to, equipment specification, equipment start-up, campaign document preparation/review, process fit within the Biologics Pilot Plant suites, technical document preparation, and planning/execution/close-out of Good Manufacturing Practice batches. Some overtime, including weekends and occasional second and third shift work, will be required during operations. Assignments include elements of preparation, execution, and closeout of a Good Manufacturing Practice campaign.

Primary Responsibilities:

• Designing and performing downstream operations such as normal flow filtration, tangential flow filtration, homogenization, lyophilization, chromatography, and centrifugation.

• Preparing critical technical documents for process readiness (e.g., Standard Operating Procedures, batch records).

• Evaluating and integrating innovative technology/process equipment fit.

• Developing equipment specifications & participating in start-up activities.

• Working in a multi-disciplinary project team environment.

• Troubleshooting downstream process unit operations.

• Leading and supporting cross-functional teams with ability to objectively resolve problems and issues.

Education Minimum Requirements:

• Bachelor’s degree in Chemical Engineering or Biological Sciences with minimum 5 years of relevant experience or a master’s degree with minimum 3 years of relevant experience.

Required Experience and Skills:

• Good Manufacturing Practice manufacturing of biologics, or vaccines, and/or process development activities.

• Subject matter expertise in one purification unit operation

• Strong teamwork and collaboration

• Extensive knowledge of cGMP, Quality Systems, and safety for operations

• Highly self-motivated with the ability to work in a fast-paced and dynamic setting with high adaptability to change.

Preferred Experience and Skills:

• Excellent organizational, problem-solving, and project management skills

• Strong technical background in large molecule operations

• Experience leading teams in a matrixed organization.

• Demonstration of Decision Making, Execution Excellence, and Ownership and Accountability Leadership Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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