Kilo Lab Lead Technician

Responsibilities

• Supports the team, follows instructions, assists with troubleshooting, collaborates cross-functionally, and upholds safety-first, quality-always mindset.
• Executes 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.
• Trains entry-level Kilo Lab Technicians with structured, hands-on instruction on manufacturing processes, equipment use, and site procedures to build skills and ensure consistent compliance.
• 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, maintains notebooks or records, and supplies written summaries to supervisors as needed.
• 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 leader for site safety culture, promoting compliant operations and positive safety behaviors; leading by example and promoting accountability at all levels.
• Provides technical leadership for 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.
• Makes interpretations of data generated and suggests subsequent experimentation; offers ways to improve efficiency of time utilization, equipment design, configurations, and process improvements.
• Partners with area management and supervision to understand Foundry strategy and future production needs; represents and supports this strategy in conversations with shift members.
• Summarizes, prepares, and tabulates data; coordinates activities with other laboratories and support groups.
• Plans own work schedule and operates with minimal supervision; level of independence increases with experience and equipment familiarity.
• Participates in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Understands and utilizes computer systems and programs for development project activities, including control or automation systems such as Delta V and Pi.

Requirements

• 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.

Qualifications

• Basic Qualifications:
• Previous experience in facility or area start-up environments.
• Prior work in pharmaceutical or chemical manufacturing involving Process Safety Management regulations or hazardous chemicals.
• Experience in the handling of controlled drugs.
• Previous experience operating kiloscale glassware and equipment such as glass reactor systems, filtration equipment (AFDs, Nutsche filters, cartridge), rotary evaporators, and pumping systems.
• Ability to work cross-functionally with PTE scientists, process engineers, operations, analytical chemists, safety and quality representatives.
• Experience in small molecule, peptide/oligonucleotide, or high-potent manufacturing operations.
• Familiarity with unit operations regarding distillation, filtration, extraction, and chromatography.
• Knowledge of FDA guidelines and cGMP requirements.
• Strong documentation skills.
• Problem-solving skills: proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Ability to understand technical nomenclature and language and work with mathematical formulas.
• Strong organizational skills with the ability to handle and prioritize multiple projects and requests.
• Demonstrated ability to manage priorities and ambiguity.
• Demonstrated initiative to solve problems, troubleshoot issues, and learn new processes and computer system applications.
• Ability to effectively communicate (electronically, written, and verbal) across levels and functions.
• Basic computer skills required; proficiency in MS Word, Excel, and PowerPoint preferred.
• Post-secondary education helpful.
• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
• Strong teamwork and interpersonal skills.
• Other Information:
• This is a manufacturing-based role.
• May be required to provide support outside of normal working hours, including nights or weekends.
• May require limited domestic and international travel (< 10%).
• Role requires ability to work in laboratory and manufacturing environments.