CMC Internal Operations Specialist

Responsibilities

• Support material management for clinical production including shipping & receiving, procurement, SAP goods receipt, inventory, and kitting activities
• Auxiliary facilities & EHS activities such as work orders, maintenance documentation review and upload to CMMS, hazard waste compliance and daily/monthly/weekly inspections
• Support internal supply chain activities for all lab teams by performing pack outs, coordinating shipments, and completing any necessary documentation
• Perform small and large scale (0-200L) solution production, including authoring and executing associated form preps
• Support upstream and downstream process development and manufacturing operations (GMP & non-GMP) for multiple programs spanning all phases of biopharmaceutical development, as required
• Interact effectively and transparently with all Kiniksa team members and stakeholders
• De bottleneck and rationalize operation processes to optimize process consistency and efficiency
• Cross-functional operational partnership and collaborate with CMC, Quality, Supply Chain, and Clinical teams to ensure alignment on manufacturing and launch activities
• Communicate timelines, risks, and inventory status to stakeholders clearly and effectively
• Understand the patient-impact of operational execution and its direct support to timely delivery of therapies to patients
• Show strong mathematical aptitude in solution preparation and calculations with confidence and precision
• Support processes that ensure safe, high-quality clinical materials through formulation support skills

Qualifications and Experience

• BS/BA degree + 0-3 years’ experience in the Biotech Industry (preferred)
• Relevant biological process development and manufacturing experience with a strong record of achievement
• Mature mathematical aptitude in solution preparation (0-200L scale)
• Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity
• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement
• Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost targets
• PREFERRED: Experience in a GMP regulated environment and good documentation practices