Process Development & Manufacturing Engineer - Biomaterials
Listed on 2026-08-03
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Manufacturing / Production
Quality Engineering, Medical Device Industry, Validation Engineer, Pharmaceutical Manufacturing
Full-Time | Tempo Therapeutics | On-site in San Diego, CA (R&D facility) Help build the next generation of regenerative biomaterials
Tempo Therapeutics is developing first-in-class regenerative biomaterials designed to help the body rebuild healthy, native tissue. Our proprietary Microporous Annealed Particle (MAP) scaffold is a synthetic, flowable biomaterial that supports tissue integration and regeneration. Tempo has demonstrated encouraging clinical results and is advancing products for complex surgical reconstruction and dermatology.
We are seeking a hands-on Process Development & Manufacturing Engineer to help develop, scale, and transfer robust manufacturing processes for our MAP granular hydrogel-based products. In this role, you will help transition innovative hydrogel technologies from development through scalable manufacturing, supporting products that advance toward clinical and commercial use.
What you’ll do- Manufacture research-grade and production-equivalent hydrogel batches.
- Lead and support process development, optimization, scale-up, troubleshooting, and characterization.
- Perform aseptic manufacturing operations, including formulation, mixing, sterile filtration, filling, and packaging.
- Prepare and maintain SOPs, batch records, protocols, reports, and work instructions.
- Support equipment qualification, process validation, and manufacturing verification.
- Assist with technology transfer to contract manufacturing organizations and support engineering, validation, and cGMP runs.
- Perform analytical, mechanical, and rheologic testing of products and intermediates.
- Support quality activities including deviation and non-conformance investigations, root causes, and CAPAs.
- Support supplier qualification, incoming material evaluation, inventory, and raw material management.
- Collaborate with R&D, Quality, Regulatory, Clinical, and external manufacturing partners.
- Ensure all activities comply with Tempo's Quality Management System.
- M.S. in Chemical Engineering, Biomedical Engineering, Bioengineering, Materials Science, Chemistry, or a related field; B.S. acceptable for otherwise highly qualified candidates.
- 2-5 years of relevant industry experience (M.S.) or 5+ years of directly relevant industry experience (B.S.).
- Experience in medical devices, biomaterials, pharmaceuticals, biologics, or combination products.
- Strong technical writing, troubleshooting, analytical, and organizational skills.
- Ability to work independently and collaborate effectively across teams.
- GMP or ISO 13485 environments
- Aseptic processing
- Sterile manufacturing
- Process scale-up
- Technology transfer
- Basic wet bench activities
- General chemistry and/or biology
- Working within a Quality Management System (QMS)
As a member of a small, highly collaborative team, you'll have broad ownership, direct visibility with company leadership, and the opportunity to shape manufacturing processes that will support future clinical and commercial products. You will help build manufacturing capabilities for a novel regenerative biomaterial platform at a pivotal stage of company growth. Tempo offers significant cross-functional exposure and the opportunity to directly support clinical, regulatory, and commercial milestones.
At Tempo, we believe in investing in our team. Our benefits programs are just one of the many ways we strive to help our employees take care of themselves and their families. We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.
Benefits include:- Competitive base salary and annual incentive opportunities
- Equity participation
- Comprehensive health and welfare benefits (including medical, dental, vision, life, disability, and accident insurance)
- Flexible paid time off and holidays
- Environment where professional development is actively encouraged and supported.
Tempo is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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