Joseph Bilikiewicz

Respected leader who manages purification and production support activities for the development, validation, and GMP manufacture of a specialty biologic. Responsible for a team of 10 including 2 Supervisors, 7 Manufacturing Associates, and a Sr. Manufacturing Specialist (staff previously exceeded 20).

• Reviewed and approved daily production schedules, ensuring alignment with site timelines and budget expectations.
• Mentored junior staff to develop skills and facilitate professional growth.
• Provided technical input to support operations and address manufacturing nonconformances.
• Troubleshot process and equipment within a GMP facility as a subject-matter expert.

Selected Project Experience:

• Led the commissioning of multiple ISO 7 production suites to sustain increased commercial run rate and scale-up.
• Managed the installation and validation of multiple new chromatography systems and columns (AKTAprocess, AKTApilot 600, and AxiChrom columns) to replace aging commercial equipment.
• Spearheaded transition of facility sanitization from third party to internal, resulting in over $200k annual savings.
• Managed process scale-up activities encompassing process development, equipment installation, and validation of MBR generation.

Supervised downstream (TFF, HIC and IEX chromatography) and manufacturing support activities for the GMP manufacture of a specialty biologic.

• Trained and developed Manufacturing Associates across all levels to enhance team capabilities.
• Provided technical input to support operations and resolved manufacturing deviations and nonconformances.
• Primary point of contact for equipment troubleshooting within the GMP facility.
• Reviewed and approved batch records, deviations, CAPAs, and Change Controls to maintain quality and regulatory compliance.
• Now Keenova Therapeutics

Mentored direct reports and managed performance, incorporating training on aseptic technique, upstream, and downstream operations to enhance team capabilities.

• Identified functional gaps within team and proposed optimizations to operational schedule, improving workflow and team effectiveness.
• Collaborated with quality assurance groups to emphasize quality principles, reviewing pre- and post-execution GMP documentation to ensure compliance and uphold standards.

Identified process enhancements during technology transfer to manufacturing through team collaboration.
Engaged with clients on technical transfer and management of clinical GMP production operations.

• Subject-matter expert accountable for authoring, revising, and reviewing batch records of assorted complexity.
• Supported scheduling, receipt, and organization of project-specific materials, ensuring compliance with quality standards and timely project execution.

Operated in a lead capacity on multiple clinical stage viral vector manufacturing processes. Key unit operations included media and buffer preparation, adherent cell passaging and harvesting, depth filtration/clarification, tangential flow filtration, ion exchange chromatography, and aseptic filling.

• Provided performance training to entry-level staff to enhance clinical manufacturing skills.
• Supported preventive maintenance for equipment to ensure operational efficiency.

Performed bacterial fermentation procedures for GMP manufacture of specialty biologic. Ensured operational success through skillful operation of fermenters, cleaning, and sterilization of equipment, and preparation of media solutions in adherence with production timelines.

• Supported validation and troubleshooting of processes and equipment to ensure compliance with manufacturing standards.
• Executed GMP tasks in compliance with approved SOPs, batch records, and other controlled documentation.