Alamar Biosciences
Manufacturing Tech Transfer Lead (contractor)
Fremont, California · Contract
Sponsorship not specifiedDetected 12 hours ago
Data AnalysisExcelProcess ImprovementCustomer SupportRoboticsGMPFDA RegulatoryPCRMolecular BiologyMedical DevicesExperimental DesignProtein AnalysisCommunicationProblem SolvingWritingMicrosoft Office
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
- This role is a laboratory position that ensures that all transfers meet quality, cost, and timeline objectives while complying with GMP, ISO, and regulatory standards.
- include planning and managing technology transfers, preparing and maintaining documentation, pilot manufacturing, and supporting validation activities such as IQ/OQ/PQ.
Responsibilities
- Design and execute experiments for troubleshooting and for enhancing process efficiency, robustness, scalability, and continuous improvement.
- Collaborate with Product Development to define material and manufacturing process specifications, in-process controls, and final product quality acceptance criteria.
- Generate pilot kit build and finalize manufacturing documents and SOPs.
- Prepare, review, and maintain technical documentation such as protocols, reports, batch records, and change management requests.
- Support the adoption and maintenance of electronic batch records and ensure record-keeping in compliance with cGMP and regulatory standards.
- Mentor and provide technical support and training to manufacturing and quality control staff, fostering knowledge transfer and best practices.
- Drive operational excellence by leading or participating in initiatives focused on process improvement and efficiency gains.
- Proven ability to manage multiple projects, prioritize tasks, and meet tight deadlines.
- Strong collaborative skills, with experience in cross-functional teams and engaging with external partners or vendors.
Requirements
- Bachelor's or Master's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
- 5-7 years of relevant industry experience in pharmaceutical manufacturing, technology transfer, or process development.
- Demonstrated expertise in reagent manufacturing, process optimization, and technology transfer within the life sciences or clinical diagnostics sector.
- Hands-on experience with molecular biology techniques (e.g., PCR, sequencing, ELISA), and the handling of oligonucleotides and proteins.
- Proficiency in experimental design, data analysis, and the use of statistical and visualization tools.
- Strong understanding of cGMP, FDA regulations, ISO 13485, QMS, and design control principles.
- Experience with electronic batch records, LIMS, and process monitoring systems.
- Familiarity with automation, robotics, laboratory instrumentation, and analytical equipment.
- Excellent technical writing, organizational, and communication skills, with the ability to present complex data to diverse audiences.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Nice to have
- Preferred Skills and Attributes
Compensation
- The base salary range for this full-time position is $55/hour - $65/hour.
Company info
- At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients.
- Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.
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This listing is sourced directly from Alamar Biosciences's careers page and normalized into a canonical job model.