About Countable Labs
At Countable Labs (formerly Enumerix), we’re reimagining the future of genomics—and we’d love for you to be a part of it! As the innovators behind our groundbreaking Countable PCR platform, we’re building tools that make a real impact in precision medicine. We’re a fast-growing startup fueled by innovation, collaboration, and a mission-driven spirit. If you’re ready to roll up your sleeves, build something from the ground up, and help shape the future of genomics, we want you on our team!
Role overview
We are seeking an experienced and driven Staff or Senior Staff Scientist to lead Reagent Manufacturing Transfer and New Product Introduction (NPI) activities within our organization. This role will serve as the critical interface between R&D and Manufacturing, responsible for successfully transitioning reagent manufacturing processes to full-scale production, overseeing process and product validation, and maintaining rigorous documentation.
What You’ll Do
- Technology transfer from R&D to production
- Lead the transfer of reagent manufacturing processes from R&D to Manufacturing.
- Translate R&D protocols into robust, scalable production procedures.
- Collaborate with cross-functional teams (R&D, Operations, and Quality) to ensure alignment on process requirements and deliverables.
- Work with R&D to define, implement, and support QC procedures for reagents, consumables, and accessories.
- Ensure new reagents and reagents produced with improved processes are integrated with the instrument platform.
- Conduct production of pilot lots of reagents.
- Train manufacturing associates on production procedures.
- Be the internal subject matter expert of all reagents used on our platform
- Scale-up and process development
- Develop and optimize scalable manufacturing processes for reagents and kits.
- Identify and implement opportunities for efficiency, scalability, and quality improvements in manufacturing processes.
- Design experiments and analyze data to support process improvements and troubleshooting.
- Oversee new product and process validation
- Create and maintain project timelines, risk assessments, and validation plans for new reagent products.
- Documentation
- Author and maintain comprehensive documentation including, but not limited to, process transfer protocols, manufacturing work instructions, batch records, process and product validation protocols and reports.
- Ensure documentation complies with applicable quality and regulatory standards (e.g., ISO 13485).
What we’re looking for
- Advanced degree (MS or PhD) in Molecular Biology, Genomics, Bioengineering, Chemical Engineering, or related field.
- 5+ years of experience in the life science tool industry, at least 2+ years of experience in tech transfer/new product introduction — exact level of role will depend on candidate experience.
- Strong understanding of the manufacturing and quality requirements of reagents in the life science tool industry.
- Experience with the manufacturing of reagents used for life science products, especially those that interface with scientific instruments.
- Strong troubleshooting skills, and ability to interpret technical data reports
- Excellent writing skills, especially with production and quality-related documents.
- Exceptional attention to detail
- Excellent communication skills, with the ability to interface with an interdisciplinary team
- Ability to thrive in a fast-paced, dynamic startup environment, balancing rigor with adaptability as priorities evolve.
