Successive Proximity Extension Amplification Reaction
Director of Technical Transfer and Operations
Successive Proximity Extension Amplification Reaction, Woburn, Massachusetts, us, 01813
Director of Technical Transfer and Operations
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 utilizing very small sample volumes. The commercial focus of the company is on supporting life sciences, clinical, and academic research. Our platform offers best-in-class sensitivity, lab-to-lab consistency, and flexibility.We are seeking a dynamic and experienced Director of Technical Transfer and Operations to lead product transfer from R&D into Manufacturing, as well as oversee troubleshooting and continuous improvements for commercially launched products. This role collaborates closely with R&D, quality and manufacturing, ensuring that all aspects of design, quality, and manufacturability are met, supporting both current and future corporate objectives.Responsibilities:Oversee the design transfer of assay product consumables from R&D through manufacturing, ensuring compliance with GMP and ISO 13485 Standards.Lead root cause investigations, issue resolution, and improvements of commercially available productsDrive cross-functional team to reach consensus, follow-up action items, hold team members accountable, prioritize work based upon need and resources available.Use a data-driven approach to makes recommendations and decisions that have a major impact on current product improvement activities.Provide technical review and approval for manufacturing related documents including device master record documents, validation protocols/reports, change notificationsExhibits strong customer focus, constantly seeking opportunities to understand customer needs and improve satisfactionRecruit, lead, and develop a high-performing multidisciplinary team to support rapid growth of product offering and revenue.Qualifications:Education: MS/Ph.D. in Biology, Biochemistry, Molecular Biology, Chemistry, Engineering, or related fields.Experience:
7+ years of experience in a manufacturing or product development in life science industry setting.Extensive experience with assay products, particularly immunoassays, and the transfer and scale-up of commercial RUO or IVD assays.Proven management experience, including the ability to recruit, lead, and develop a productive team
Skills:
Ability to adapt into a past paced and high growth organizationStrong problem-solving abilities and a commitment to continuous improvement.Effective communication skills for cross-functional collaboration and customer interactions.
We offer a 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.
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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 utilizing very small sample volumes. The commercial focus of the company is on supporting life sciences, clinical, and academic research. Our platform offers best-in-class sensitivity, lab-to-lab consistency, and flexibility.We are seeking a dynamic and experienced Director of Technical Transfer and Operations to lead product transfer from R&D into Manufacturing, as well as oversee troubleshooting and continuous improvements for commercially launched products. This role collaborates closely with R&D, quality and manufacturing, ensuring that all aspects of design, quality, and manufacturability are met, supporting both current and future corporate objectives.Responsibilities:Oversee the design transfer of assay product consumables from R&D through manufacturing, ensuring compliance with GMP and ISO 13485 Standards.Lead root cause investigations, issue resolution, and improvements of commercially available productsDrive cross-functional team to reach consensus, follow-up action items, hold team members accountable, prioritize work based upon need and resources available.Use a data-driven approach to makes recommendations and decisions that have a major impact on current product improvement activities.Provide technical review and approval for manufacturing related documents including device master record documents, validation protocols/reports, change notificationsExhibits strong customer focus, constantly seeking opportunities to understand customer needs and improve satisfactionRecruit, lead, and develop a high-performing multidisciplinary team to support rapid growth of product offering and revenue.Qualifications:Education: MS/Ph.D. in Biology, Biochemistry, Molecular Biology, Chemistry, Engineering, or related fields.Experience:
7+ years of experience in a manufacturing or product development in life science industry setting.Extensive experience with assay products, particularly immunoassays, and the transfer and scale-up of commercial RUO or IVD assays.Proven management experience, including the ability to recruit, lead, and develop a productive team
Skills:
Ability to adapt into a past paced and high growth organizationStrong problem-solving abilities and a commitment to continuous improvement.Effective communication skills for cross-functional collaboration and customer interactions.
We offer a 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.
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