Kilo Lab Lead Technician

Responsibilities

• Supports the team, follows instructions, assists with troubleshooting, collaborates cross-functionally, and upholds safety-first, quality-always mindset.
• Ensures supply of medicines by 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.
• Provides on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift.
• 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.
• 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 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.
• 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.
• Partners with area management and supervision to understand Foundry strategy and future production needs; representing and supporting this strategy in conversations with shift members.
• 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.
• Understands and utilizes computer systems and programs for development project activities, including control or automation systems such as Delta V and Pi.
• Uses 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.
• Performs clean room gowning and wears 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.
• 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.
• Solid understanding of FDA guidelines and cGMP requirements.
• Demonstrated strong documentation skills.
• Knowledge of lean manufacturing principles.
• Problem-solving skills: proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
• Proven 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.