Position title: Process Engineer
At Tempo Therapeutics, we are pioneering a new era in tissue engineering and regenerative medicine with our cutting edge Microporous Annealed Particle (MAP) technology platform. Our team is developing next generation biomaterials to build precision scaffolds for use in surgical oncology, organ regeneration, stem cell, and drug delivery. Our mission is to harness the power of MAP technology to transform patient outcomes for those in need.
To achieve this mission, we are recruiting top talent and building a dynamic, fast-paced, and collaborative environment that enables our team to do their best work and make a real impact on society.
Tempo is seeking a highly motivated individual to fill the role of Process Engineer to join the Product and Process Development team at our headquarters in San Diego, CA. Applicants must have a Bachelor of Science in a technical field and 2 - 5 years of industry experience. The successful candidate will be responsible for the development and optimization of manufacturing processes for production of Tempo's unique hydrogel microsphere products. This position requires hands-on expertise in process development, scale-up, and tech transfer to commercial production environments.
Responsibilities:
- Own development of manufacturing process for new and existing product formulations by characterizing baseline performance and capabilities of each process.
- Derive & execute studies (DOEs) to characterize boundary conditions and optimize process for manufacturability and quality.
- Work with R&D to develop test methods and ensure new products have manufacturability in consideration during development (DFM).
- Identify and manage process risks with use of pFMEA, utilize risk-based approach to determine requirements for sample size, test method validations, and other statistical analyses.
- Provide technical guidance and feedback on engineering practices and study development to junior members of the technical staff.
- Work with material and equipment vendors and Contract Manufacturers as needed.
- Support compliance with cGMP, GDP, regulatory, and internal requirements.
- Generate and maintain process documentation including process specifications, equipment & calibration info, setup drawings, BOMs, and process flowcharts.
Preferred Skills and Experience:
- Medical device, biologic, or pharmaceutical process development
- Basic wet bench activities
-
General chemistry and/or biology
-
Aseptic techniques (working in a BSC or ISO-5 hood)
-
Knowledge of Tangential Flow Filtration (TFF)
-
Experience with biochemical purification systems
- Design of Experiments methodologies (DOE)
- Principles of Design for Manufacturability (DFM), Current Good Manufacturing and Documentation Practices (cGMP and GDP)
-
Knowledge of biomaterials/tissue engineering
-
Skilled in statistical data analysis
-
Working within a Quality Management System (QMS)
Basic Qualifications:
-
Bachelor's degree with 2-5 years of relevant industry experience
-
Degree in Biomedical/Bio Engineering, Chemical Engineering, Manufacturing Engineering or similar technical field
-
Excellent oral and written communication skills
-
Self-motivated, detail-oriented and willingness to take on different work assignments
Benefits and Compensation:
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)
-
Paid time off and holidays
-
Retirement benefit account with generous employer matching contribution
-
Flexible work arrangements
-
Environment where professional development is actively encouraged and supported
Salary:
We believe in transparency and fair compensation. To help you make an informed decision, we've included the expected salary range for this role below. Final compensation will be determined based on the candidate's background, qualifications and relevant experience.
Salary range: $75,000-$105,000
Equal Opportunity Statement
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.