Process Development Chemist

Job Summary

As a Process Development Chemist, you will manufacture reagents according to SOPs and applicable quality and manufacturing requirements, ensuring reagent consistency, working alongside reagent planning, dispensing, and quality assurance teams. You will have the opportunity to collaborate with cross-functional teams, including R&D, for troubleshooting, continuous improvement, and implementing novel processes to support consistent reagent performance for downstream lab workflows.

Key Responsibilities

• Execute product manufacturing according to established procedures (SOPs) using good manufacturing practice (GMP).
• Manufacture products in alignment with quality and safety requirements (ISO 9001/14001/45001).
• Execute QC testing of raw materials and final products and document results per established procedures.
• Maintain strong laboratory practices, including accurate recordkeeping with a readiness for audits and quality reviews.
• Support general lab functions, setup, calibration, and maintenance of equipment.
• Collaborate with scientists and production teams to troubleshoot issues, refine standard work, and support scale-up and process validation activities.
• Support reagent manufacturing through change control activities, batch documentation reviews, and continuous improvement initiatives.
• Participate in inventory receipt, maintenance, and control of raw materials, products, and lab supplies.
• Facilitate investigations, recording, and implementation of product deviations or CAPA systems.
• Independently troubleshoot and resolve routine issues using established procedures, escalating complex issues as needed.
• Work safely and in compliance with all applicable company, federal and local regulations.
• May be required to label, dispense, and package reagents and final products.

Basic Qualifications

• Bachelor’s degree in life or natural sciences discipline
• 2 years of laboratory experience.
• 1 year of experience with basic computer skills (Microsoft suite including Word, Excel, and Teams) for data analysis, record-keeping, and document maintenance.

Preferred Qualifications

• Good project management, organization skills, and attention to detail and accuracy; maintain good laboratory documentation practices; ability to handle multiple projects or tasks in a fast-paced environment.
• Experience with reagent or chemical manufacturing workflows, including tech transfer or production support is highly desired but not required.
• Familiarity with method validation concepts and routine quality documentation practices.
• Familiarity with applicable analytical tools including UV-Vis, fluorometers, or similarly related equipment.
• Experience with electrophoretic analysis relevant to proteins, DNA, and/or RNA (or strong capability to learn and apply these techniques quickly).
• Demonstrates strong interpersonal skills (verbal and written communication) and is enthusiastic to work with and provide support in a cross-functional team environment.
• Problem solver, with a positive, proactive, can-do attitude; knows when to ask for help and how to help others.
• Willingness to learn new concepts, challenge boundaries, and adjust to changing priorities effectively.

Physical Requirements

May require the ability to lift 25 pounds and stand for long periods of time.