Product Transfer Specialist

2 weeks ago


Woburn, Massachusetts, United States Spear Bio Full time

{"h1": "Product Transfer Engineer or Scientist at Spear Bio", "p": "Spear Bio is a rapidly growing start-up company based in the United States. We are focused on developing a novel ultrasensitive immunoassay platform for the biotechnology industry. We are 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, ensuring seamless product transfer and compliance with regulatory standards.

Responsibilities:

* Draft detailed manufacturing and test protocols to ensure smooth product transfer from R&D to manufacturing.
* Build and update the bill of materials (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 efficient production.
* Collaborate with R&D, Quality, and Manufacturing teams to facilitate product transfer and resolve technical issues.
* Ensure all transfer activities are well-documented and compliant with FDA and ISO 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. 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 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.

If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.

We look forward to hearing from you"}



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