Reagent Specialist

Proclinical is seeking a Reagent Specialist for a startup biotech company located in San Francisco, CA.

The Reagent Specialist will work closely with cross-functional teams, including R&D, operations, and external partners, to ensure timely and efficient production of high-quality reagents for flow cytometry applications.

Must be eligible to work in the US.

Job Responsibilities:

• Collaborate with R&D team and external partners to develop and optimize new reagent formulations used in VisionSort TM platform, ensuring optimal performance and stability.
• Handle day-to-day production of reagents in accordance with specifications, established protocols and standard operating procedures (SOPs) with limited supervision.
• Troubleshoot and resolve any formulation or packaging issues.
• Identify and source raw materials required for reagent production, ensuring timely availability and compliance with quality standards.
• Assist with logistical processes for finished goods, semi-finished goods, and raw materials including packing, printing labels, incoming goods inspection, and receipt.
• Collaborate with suppliers and Operation team to evaluate quality and resolve any quality issues.
• Maintain accurate records of raw material inventory and coordinate replenishment as needed.
• Conduct rigorous QC testing of reagents to ensure compliance with established specifications and performance standards. Use various analytical techniques to verify reagent quality. Document and report QC results and troubleshoot and resolve any quality issues.
• Complete Batch Manufacturing Records (BMRs), ensuring that all information is timely, accurate, legible, and correct to guarantee traceability.
• Continuously identify and implement process improvement initiatives to enhance reagent formulation, packaging, and QC processes.
• Communicate production issues and potential solutions to management as they arise.
• Collaborate with cross-functional teams to implement best practices, optimize workflows, and improve efficiency and quality of reagent production.
• Maintain accurate and up-to-date documentation of formulation, packaging, and QC processes in accordance with regulatory requirements and company policies.
• Adhere to the company's safety policies and procedures and report hazards to ensure a safe and healthy workplace environment.
• Participate in audits and inspections as needed and assist with preparing documentation for regulatory submissions.
• Performs other related duties and assignments as required.

Skills and Requirements:

• Bachelor's degree in chemistry, biochemistry, biological sciences, or related field.
• Minimum 3-5 years of experience in hands-on reagent formulation, packaging, and quality control in the life science industry.
• Experience in cGMP, GLP manufacturing and/or analytical laboratories is preferred.
• Strong understanding of flow cytometry principles, reagent formulation, and quality control processes is a plus.
• Basic knowledge of raw material sourcing and inventory control.
• Familiarity with regulatory requirements for reagent production, such as FDA regulations, GMP, GLP, and ISO 13485 is preferred.
• Excellent analytical and problem-solving skills, with attention to detail and accuracy.
• Strong organizational and time management skills, with the ability to work independently and meet deadlines.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Proficient in using analytical instruments, software, and tools for QC testing and data analysis.
• Ability to adapt to changing priorities and work in a fast-paced environment.

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) 617-671-0335 or s.jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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