Process Development & Manufacturing Specialist I
Responsibilities / How you will make an impact:
- Execute enzyme production and manufacturing processes, including fermentation, enzymatic reactions, filtration, and chromatography, following established protocols.
- Prepare materials, equipment, and production areas to support manufacturing activities and ensure readiness for scheduled operations.
- Accurately document production and experimental activities in batch records, logs, and reports in accordance with Good Documentation Practices (GDP).
- Operate and maintain laboratory and manufacturing equipment; perform basic troubleshooting and routine maintenance.
- Support process characterization and development activities under supervision to improve product quality and consistency.
- Collaborate with Manufacturing, Quality, and Supply Chain teams to support production schedules and material flow.
- Maintain compliance with cGMP (as applicable), ISO standards, and safety requirements.
Qualifications / Skills / Experience:
- High school diploma with 2+ years of relevant industry experience, or Associateโs/Bachelorโs degree in Biochemistry, Biology, or related discipline (preferred).
- Hands-on experience or exposure to enzyme production/manufacturing processes (fermentation, filtration, chromatography, or enzymatic reactions) (preferred).
- Basic understanding of GMP, ISO, and regulated manufacturing environments and GDP.
- Ability to follow SOPs and execute protocols with attention to detail and data accuracy.
- Strong organizational and problem-solving skills; ability to manage multiple tasks.
- Effective communication and teamwork; Microsoft Office proficiency; familiarity with ERP or document control systems (plus).
Benefits (highlights):
- RSU grants and optional employee stock purchase plan; comprehensive medical plans with HSA/FSA options; fertility/family planning assistance; retirement contributions; paid holidays and time off.