Product Transfer Engineer or Scientist

Job Description

Job Description

Salary :

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.

Spear Bio is seeking a dedicated and experienced 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. This includes drafting manufacturing and test protocols, building and updating the bill of materials (BOM), constructing pilot or design transfer lots, and training manufacturing staff.

The ideal candidate will have a deep understanding and hands-on experiences on product development and manufacturing processes within the biotechnology industry.

IN ORDER TO APPLY FOR THIS POSITION, CLICK ON THIS LINK : https : / / spearbio.bamboohr.com / careers / 44?source aWQ9MzE%3D

Responsibilities :

• Draft 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.
• Build 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.
• Work closely 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.
• Ensure all product transfer activities comply with FDA and ISO standards.

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

Education and Experience :

• Degree : BS / BA in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology or chemistry, or a related field.
• Experience : 3+ years of relevant experience in product transfer, manufacturing engineering, or a related role in a regulated industry.

IN ORDER TO APPLY FOR THIS POSITION, CLICK ON THIS LINK : https : / / spearbio.bamboohr.com / careers / 44?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.