Sr. Scientist 2, Product Development

Fremont , United States

AI overview

Drive product transfer and QC methods development for innovative reagent-based products in a rapidly growing biotech environment.

At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.

The Product Development team is seeking a highly motivated and capable Sr. Scientist 2. This person will be a key technical leader, responsible for developing, optimizing, and transferring novel reagent-based products and processes from R&D to Operations. This role requires deep expertise in product and process transfer, quality control (QC) methods development, with a strong track record of launching multiple complex products in the life sciences or biotech industry. Experience with lyophilization process development is highly desirable. 

Key Responsibilities

  • Lead product and process transfer activities, ensuring seamless transition from R&D to manufacturing. 
  • Design, develop, and validate QC methods and specifications for enzyme mixes, reagents, and lyophilized products. 
  • Develop and implement scalable, cost-effective production processes for complex reagents and assays. 
  • Lead investigations and resolutions for product/process deviations. 
  • Manage multi-disciplinary continuous improvement projects from conception to conclusion 
  • Lead guard banding studies to establish manufacturing tolerances. 
  • Prepare and review technical documentation, including SOPs, batch records, product specifications, and technology transfer packages. 
  • Work closely with R&D, Manufacturing, Quality, Commercial and Regulatory teams to support design transfer, risk assessments, and process validations. 
  • Mentor junior scientists and provide technical guidance. 
  • Ensure compliance with ISO 13485, and other relevant standards. 

 Qualifications 

  • Ph.D. in Biochemistry, Molecular Biology, Chemistry, or related field with 10+ years of industry experience; or M.S. with 12+ years of relevant experience. 
  • Experience with molecular assay development (PCR, qPCR, NGS), immunoassays, and/or IVD product development. 
  • Demonstrated expertise in New Product Introduction and QC methods development within a regulated and/or ISO-compliant environment. 
  • Proven track record of leading product/process transfer and launch as well as on-market sustaining activities for commercially successful biotech products. 
  • Proficiency in statistical analysis and data tools (e.g., JMP, Python), especially in the context of process optimization or QC specification setting. 
  • Exceptionally strong technical writing and documentation skills. 
  • Excellent communication, organizational, and troubleshooting skills. 
  • Proven ability to mentor and lead junior scientists. 

Preferred Qualifications 

  • Expertise with lyophilization process development and reagent stabilization. 
  • Familiarity with automated sample preparation instruments and system integration. 

The base salary range for this full-time position is $140,000 - $160,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process. 

Salary
$140,000 – $160,000 per year
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