Spear Bio is a well-funded and rapidly growing start-up company based in Woburn, Massachusetts. We are focused on bringing to market a novel ultrasensitive immunoassay platform capable of utilizing small sample volumes with excellent data quality.
We are seeking an experienced and motivated Senior or Principal Process Development Engineer or Scientist to join our Product and Process Development team. As an expert in process development, this individual will provide technical leadership for manufacturing process development, new product introduction, and technical support. This role requires a strong team player and change implementer to drive robust and scalable reagent manufacturing processes. The candidate will collaborate cross-functionally with Manufacturing, R&D, and QA/RA to achieve company and project goals.
IN ORDER TO APPLY FOR THIS POSITION, CLICK ON THIS LINK: https://spearbio.bamboohr.com/careers/42?source=aWQ9MzE%3D
Responsibilities:
- Provide expert technical leadership in immunoassay reagent manufacturing process development and new product introduction.
- Establish reagent manufacturing process requirements to meet product specifications.
- Translate technical requirements into defined and documented manufacturing specifications and procedures.
- Lead the development, optimization, and scale-up of reagent manufacturing processes to achieve product launch and business goals.
- 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 in collaboration with internal stakeholders and external suppliers.
- Independently design, develop, and execute experiments to justify technical decisions.
- Plan, develop, and coordinate multiple product and process development or manufacturing improvement projects with a high degree of creativity, foresight, and mature judgment.
- Become a subject matter expert in reagent manufacturing processes, including root cause investigations, validations, and other internal processes.
- Provide general guidance, career development, and training to lower-level support staff.
Qualifications:
- Work experience in Biotech, Life Sciences, or Pharmaceutical industries preferred.
- Hands-on experience with molecular biology or microbiology techniques.
- Experience in reagent/consumables production and product development.
- Proficiency in applying statistical tools including DOE, Gage R&R, process capability, and Statistical Process Control.
- Demonstrated ability to solve challenging, interdisciplinary technical challenges.
- Excellent interpersonal skills and the ability to function effectively in a team environment.
Education and Experience:
- BS/BA in Chemical Engineering, Biochemical Engineering, Bioengineering, Biology, or Chemistry with 7+ years of relevant experience in product and process development or manufacturing support roles.
- MS in Engineering, Biology, Chemistry, or related disciplines with 5+ years of experience.
- PhD in Engineering, Biology, Chemistry, or related disciplines with 3+ years of experience.
IN ORDER TO APPLY FOR THIS POSITION, CLICK ON THIS LINK: https://spearbio.bamboohr.com/careers/42?source=aWQ9MzE%3D
We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter a high-growth startup company at an early stage. We are recruiting candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of- and the effort involved in- building an industry-leading company.
Spear Bio Inc. 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.