Kilo Lab Technician

Responsibilities

• Ensures the supply of our medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding our safety-first, quality-always mindset.
• Supports the team in executing the transfer of chemical processes from development laboratories to kiloscale operations, supporting clinical supply activities across multiple modalities including small molecules, peptides, oligonucleotides, and high-potent compounds.
• Operates processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet the production schedule.
• Conducts lab or pilot plant experiments, maintaining notebooks or records, and supplying written summaries to supervisors as needed.
• Accurately dispenses materials as requested and executes written and verbal directions, including material testing, complex experimental designs, and/or process scaling up to pilot plant level.
• Ensures completion of daily monitoring, testing, and cleaning duties to keep equipment and systems in good operating condition per local and corporate regulatory requirements.
• Assembles and disassembles machinery for processing of materials, demonstrating strong mechanical aptitude.
• Serves as a cultural contributor to site safety culture, promoting compliant operations and positive safety behaviors.
• Supports troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
• Follows all applicable procedures for safety event reporting and documentation, including spill response, issue escalation, and initiating Emergency Response procedures as needed.
• Ensures adequate communication at shift changeovers and participates in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Ensures all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Summarizes, prepares, and tabulates data; coordinates activities with other laboratories and support groups.
• Makes interpretations of data generated and suggests subsequent experimentation; offers ways to improve efficiency of time utilization, equipment design, configurations, and process improvements.
• Plans own work schedule and operates with minimal supervision; level of independence increases with experience and equipment familiarity.
• Actively participates in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Understanding and utilizing computer systems and programs for development project activities, including control or automation systems such as Delta V and Pi.
• Using specified company-supplied personal protective equipment (PPE) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.
• Performing clean room gowning and wearing respirators and safety equipment during processing and cleaning of equipment/rooms.

Qualifications

• High School Diploma or GED required.
• 3+ years of direct manufacturing experience; GMP and/or chemical processing strongly preferred.
• Demonstrated learning agility to operate a variety of new equipment and systems.
• Strong mechanical aptitude and experience working with solvents and large equipment.
• Demonstrated experience in manufacturing, cGMP, or a regulated environment.
• Authorized to work in the United States on a full-time basis.