Manufacturing Associate II

Job Description

The Manufacturing Associate II supports the reagent formulation team by performing hands‑on manufacturing and quality control of reagent and buffer consumables. This role focuses on reagent formulation, filling, packaging, and analytical testing while ensuring accurate documentation, inventory control, and continuous improvement of batch records and standard operating procedures. The position operates in a fast-paced, multi‑disciplinary environment and contributes directly to both production goals and research and development needs.

• Perform assigned manufacturing tasks for reagents and buffers according to established batch records and standard operating procedures.

• Carry out simple buffer formulations up to 50 liters, ensuring accuracy, consistency, and compliance with specifications.

• Perform troubleshooting on formulations, filling processes, packaging operations, and analytical techniques to resolve issues and maintain product quality.

• Conduct quality control procedures for consumable products, including testing and verification using standard laboratory equipment.

• Collect, record, and analyze data generated during manufacturing and quality control activities, ensuring accuracy and completeness.

• Process work orders to completion, including manufacturing, testing, and releasing products to inventory.

• Execute batch records and SOPs with high attention to detail, and contribute to improving and updating these documents to enhance process robustness and efficiency.

• Identify gaps and weaknesses in SOPs, formulations, and processes for finished goods and component materials, and recommend improvements.

• Maintain accurate inventory of materials through regular cycle counts, ordering, and receipt of raw materials and components.

• Support filling operations and provide fill support to ensure timely and accurate completion of production runs.

• Lead kit support activities, including leading a production line for kit assembly and ensuring all components meet quality and documentation requirements.

• Support reagent formulation equipment and instruments through calibration, validation, and basic troubleshooting activities.

• Update and track daily usage of reagents and consumables, ensuring R&D and development teams receive required materials on time.

• Collaborate closely with scientists, engineers, and other manufacturing personnel as part of a multi-disciplinary team to support R&D and process improvement activities.

• Operate effectively in a fast-paced environment with rapidly shifting priorities while maintaining quality and compliance.

• Perform other related duties as assigned to support manufacturing, quality, and development objectives.

• Hands‑on experience with reagent and buffer formulations in a laboratory or manufacturing setting.

• Experience working with standard operating procedures (SOPs), batch records (BRs), and work instructions (WIs).

• Proficiency in general laboratory skills, including safe handling of reagents and operation of basic lab equipment.

• Hands‑on experience using pH meters, conductivity meters, UV-Vis spectrophotometers, and other standard laboratory instruments.

• Ability to perform basic troubleshooting on formulations, filling processes, packaging operations, and analytical methods.

• Strong quality mindset with experience performing quality control procedures for consumables.

• Ability to collect, organize, and analyze data accurately to support manufacturing and quality decisions.

• High level of attention to detail with strong analytical thinking skills.

• Strong verbal and written communication skills, including the ability to document work clearly and accurately.

• Proficiency with Excel, Word, Confluence, and web‑based or similar programs for documentation and data management.

• Self‑motivated with the ability to work independently and as part of a team.

• Highly organized and flexible, with the ability to manage multiple tasks and shifting priorities.

• Bachelor of Science degree in biology, biochemistry, chemistry, molecular biology, or a related life science discipline preferred.

• 2 years of relevant experience in consumable…