Sr. Spclst, Engineering

Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state‑of‑the‑art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Senior Specialist, GMP Process Operations, serves as a technical expert and operational leader within the upstream bioreactor operations team. This role is hands‑on, providing both direct process execution and leadership across multiple manufacturing campaigns. The Senior Specialist applies deep technical knowledge of bioreactor systems and GMP compliance to ensure successful production of clinical materials, effective technology transfer of new processes and continuous improvement of manufacturing operations.

Key Responsibilities:

• Lead and execute GMP bioreactor operations across multiple scales ranging from benchtop to 2000 L in stainless steel, glass, and single‑use systems.

• Direct and coordinate upstream campaign teams ensuring safety compliance and schedule adherence.

• Serve as a subject matter expert for bioreactor operations, including system design, process control, and troubleshooting.

• Provide technical leadership in deviation investigations, CAPA implementation and change control activities.

• Partner with process development, engineering and quality to introduce, scale, and optimize new processes in the GMP manufacturing environment.

• Drive continuous improvement initiatives related to process robustness, equipment reliability, and operational efficiency.

• Mentor and train Specialists and Associate Specialists in technical execution, GMP documentation, and problem‑solving methodologies.

• Maintain accurate and compliant documentation including batch records, logbooks, and deviation reports.

• Promote a strong safety and quality culture through example and engagement.

#PRD

Education:

• Bachelor’s degree in biology, biotechnology, chemical engineering, or related field with 5 or more years of relevant experience, or

• Master’s degree with 3 or more years of relevant experience.

Experience:

Required:

• Demonstrated technical expertise in bioreactor operations and upstream bioprocessing.

Preferred:

• Proven experience leading manufacturing teams in a GMP environment.

• Proficiency with Delta
  
  V and/or Unicorn control systems preferred.

• Experience supporting or owning deviations, CAPAs and change controls.

• Strong working knowledge of GMP documentation and regulatory expectations for clinical manufacturing.

Key Attributes:

• Recognized as a technical leader with strong analytical and troubleshooting skills.

• Demonstrated ability to lead teams and foster collaboration across functions.

• High degree of ownership, accountability, and professional integrity.

• Effective communicator capable of translating complex technical concepts to diverse audiences.

• Flexible and adaptable to dynamic clinical production environments including off‑shift work as required.

Required Skills:

Adaptability, Analytical Testing, Biomanufacturing, Biotechnology, Chemical Biology, Chemical Engineering, Chemical Technology, Continuous Process Improvement, Data Analysis, Detail‑Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Safety Compliance, Strategic Thinking, Technical Leadership, Technical Problem‑Solving, Technical Writing

Preferred

Skills:

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  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…