Product Transfer Specialist

2 weeks ago


Woburn, Massachusetts, United States Spear Bio Full time
Product Transfer Engineer or Scientist Job Description

Spear Bio, a rapidly growing start-up company in Woburn, Massachusetts, is seeking a dedicated Product Transfer Engineer or Scientist to join our Product Transfer team.

The successful candidate will play a critical role in transferring products from R&D to manufacturing, drafting manufacturing and test protocols, building and updating the bill of materials (BOM), constructing pilot or design transfer lots, and training manufacturing staff.

This is an opportunity to enter a high-growth startup company at an early stage and contribute to the development of a novel ultrasensitive immunoassay platform.

Responsibilities:
  • Develop and implement detailed manufacturing and test protocols to ensure seamless product transfer from R&D to manufacturing.
  • Build and update the BOM for new products, ensuring all components are accurately listed and sourced.
  • Construct pilot and design transfer lots to validate manufacturing processes and ensure product performance and quality.
  • Train manufacturing staff on new protocols and processes to ensure smooth and efficient production.
  • Collaborate with R&D, Quality, and Manufacturing teams to facilitate product transfer and resolve any technical issues.
  • Ensure all transfer activities are well-documented and compliant with regulatory standards.
  • Identify opportunities for process improvements and implement changes to enhance efficiency and product quality.
Qualifications:
  • Previous experience in product transfer, manufacturing engineering, or a related field in the biotechnology, life sciences, or pharmaceutical industries.
  • Strong analytical and problem-solving skills to address and resolve technical issues.
  • Excellent communication skills to effectively collaborate with cross-functional teams.
  • High attention to detail to ensure accuracy in documentation and protocols.
  • Familiarity with FDA and/or ISO quality standards for medical device and in-vitro diagnostic products a plus.

We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. Spear Bio Inc. provides equal opportunity in employment to all persons.



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