Chief Process Development Engineer

6 days ago


Woburn, Massachusetts, United States Spear Bio Full time

Spear Bio, a well-funded and rapidly growing start-up headquartered in the United States, is dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable and ultrasensitive solutions. Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), offers unprecedented sensitivity for accurate measurement of low abundant biomarkers.

We are seeking an experienced Chief Process Development Engineer to join our Process & Product Development team. This individual will provide technical leadership for commercial manufacturing process development, new product introduction, and technical support. The successful candidate will collaborate cross-functionally with Manufacturing, R&D, and QA/RA to achieve company and project goals.

Key Responsibilities:
  • Lead the development, optimization, and scale-up of reagent manufacturing processes to meet target product launch and business goals.
  • Establish reagent manufacturing process requirements to meet product specifications.
  • Translate technical requirements into defined and documentable manufacturing specifications and procedures.
  • Solve challenging, interdisciplinary technical problems at the interface of biology, chemistry, engineering, and materials science.
  • Develop test methods to assess raw material quality.
  • Define, source, install, and qualify manufacturing equipment to support process and product volume requirements.
Qualifications:
  • Bachelor's or Master's degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology, or Chemistry with 6+ years of relevant work experience; or PhD with 2+ years of relevant experience.
  • Direct experience in process development or manufacturing support within in-vitro diagnostics, biotech, life sciences, or pharmaceutical industries required.
  • Experience applying statistical tools including DOE, process capability, and Statistical Process Control.
  • Excellent interpersonal skills and ability to function in a team environment.
  • Strong work ethic and ability to generate high-quality output in a fast-paced environment.

The estimated salary for this position is $140,000 - $180,000 per year, depending on experience. We offer competitive compensation, strong benefits, and a great work environment. Spear Bio provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.



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