Supervisor

Description:

We are seeking a highly analytical, detail-oriented, and experienced Supervisor, Manufacturing Operations  to join our Panel Manufacturing team. This role is responsible for overseeing the planning, manufacturing, and reporting of antibodies conjugates for Single- and Multi-plex platforms  to support NULISA™ production. This position plays a critical role in ensuring timely and quality antibody-oligonucleotide conjugations, efficient inventory usage, accurate material consumption reporting, and informed decision-making in post-QC workflows. This position also includes supervisory responsibilities, providing guidance and mentorship to other Manufacturing Associates involved in conjugation operations.

Key Responsibilities:

• Planning: Develop weekly antibodies conjugation production schedules based on inventory needs and availability. Coordinate with internal teams to ensure timely execution and reporting of manufacturing activities.
• Inventory & Consumption: Monitor and report antibodies panel formulation activities and associated material consumption. Collaborate with Supply Chain to ensure availability and alignment of conjugation supplies.
• Cross-Functional Collaboration: Partner with QC and R&D teams to achieve panel production outcomes.
• Supervision and Training: Supervise Manufacturing Associates to ensure adherence to protocols and quality standards. Train new manufacturing staff on procedures, equipment, and troubleshooting.
• Technical Oversight: Investigate and resolve technical issues in antibody conjugation, implementing corrective actions as needed. Ensure Hamilton liquid dispensers are maintained in a controlled state and preventive maintenance (PM) is completed on schedule.
• Documentation & Compliance: Perform review of manufacturing batch records (MPRs) for accuracy and ensure proper filing. Draft and revise production records, SOPs, protocols, and reports. Initiate and close deviation reports and change requests.
• Process Transfer and Improvement: Partner with Product Development to transfer new processes into Manufacturing. Generate compliant production records and SOPs. Drive process improvements to enhance efficiency, quality, and sustainability.
• Safety Compliance: Follow best safety practices and documented procedures to maintain a safe working environment. Ensure operations align with ISO 13485/cGMP standards.

Required Qualifications:

• Bachelor’s degree or higher in Chemistry, Molecular Biology, or a related field.
• Minimum 7 years of experience in complex pharmaceutical or biotechnology manufacturing with at least 2 years in a leadership role. Hands on experience in multiplex platforms and conjugation chemistry preferred.
• Proven experience in production planning and working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) environments.
• Hands-on experience with Hamilton liquid dispensers or equivalent automated liquid handling systems.
• Solid analytical skills for interpreting manufacturing data and resolving production issues.
• Familiarity with ERP systems and production planning tools is a plus.
• Experience in process development, transfer, and optimization is a plus.
• Mechanical aptitude for troubleshooting and performing PM on automated liquid handling systems is a plus.
• Experience in validation protocol execution.
• Excellent communication skills and attention to detail.
• Ability to thrive in a fast-paced, dynamic team environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint, Project).

The base salary range for this full-time position is $110,000 - $130,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.