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 Process Operations Specialist is responsible for leading and executing GMP bioreactor operations in support of clinical manufacturing campaigns, ensuring consistent execution of upstream processes and supporting integration with other process areas. The Specialist applies technical knowledge, problem solving and leadership skills to deliver high-quality, compliant biomanufacturing operations.

• Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000L in stainless steel, glass, and single-use systems.
• Lead small teams in the preparation, setup, operation, and teardown of bioreactors and associated support systems.
• Perform in-process monitoring, sampling, and real‑time data review to ensure process performance and compliance.
• Troubleshoot process and equipment issues, collaborating with engineering, process development, and quality functions to resolve deviations and maintain production flow.
• Support new process introduction, scale‑up activities, and technical transfer into GMP operations.
• Maintain and complete GMP documentation, including batch records, logbooks, and deviation reports in compliance with regulatory and site standards.
• Promote a strong safety culture and adherence to environmental, health and safety procedures.
• Participate in continuous improvement initiatives focused on process robustness, equipment reliability, and operational efficiency.
• Train and mentor less‑experienced staff in GMP operations, equipment use, and documentation practices.

• Bachelor's degree in biology, biotechnology, chemical engineering, or related field with a minimum of 2 years of relevant experience.
• Master's degree with a minimum of 1 year of relevant experience.

• Hands‑on experience with bioreactor operations.

• Experience with Delta
  
  V and/or Unicorn control systems strongly preferred.
• Working knowledge of GMP documentation, deviation management, and aseptic technique.
• Familiarity with upstream and downstream unit operations in biopharmaceutical manufacturing.
• Proven ability to lead teams.

• Strong ownership and accountability for assigned tasks and team outcomes.
• Ability to work effectively in a team‑based, matrixed environment.
• Flexible and adaptable to changing priorities, including off‑shift work as needed.
• Excellent attention to detail, communication, and documentation skills.
• Commitment to maintaining the highest standards of safety, quality, and compliance.

• Adaptability
• Adaptability
• Aseptic Technique
• Biomanufacturing
• Biotechnology
• cGMP Guidelines
• Chemical Biology
• Chemical Engineering
• Chemical Technology
• Electronic Batch Records
• GMP Compliance
• Laboratory Experiments
• Mammalian Cell Culture
• Occupational Health and Safety Management
• Personal Initiative
• Pilot Plant Operations
• Process Design
• Process Engineering
• Process Optimization
• Product Formulation
• Safety Standards
• Standard Operating Procedure (SOP) Writing
• Standards Compliance
• Sterile Manufacturing
• Teamwork
• + 2 more

Current Employees apply HERE

Current Contingent Workers apply HERE

Effective September 5 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site per week, Monday‑Thursday, although the specific days may vary by site or organization, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to field‑based positions; facility‑based, manufacturing‑based, or research‑based positions where the work to be performed is located at a Company site;

positions covered by a collective‑bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the…