Sr. Manufacturing Associate at Alamar Biosciences

Fremont, California, United States

Alamar Biosciences Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalIndustries

Requirements

  • B.S. or B.A. degree in Biology, Chemistry or equivalent with 6+ years of relevant experience in reagents manufacturing
  • Strong verbal and written communication skills
  • Hands-on experience with antibody conjugation and automated liquid handlers preferred
  • Able to work and deliver expected results with a high degree of autonomy
  • Ability to handle multiple tasks
  • Experience working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry highly preferred
  • Highly disciplined, energetic, and results-driven
  • Capable of working independently by following standard operating procedures (SOPs) with moderate training
  • Capable of establishing methods and approaches for new tasks and offering support or direction to junior team members
  • Act as Subject Matter Expert in Manufacturing, leveraging technical expertise for troubleshooting and continuous process optimization
  • Under moderate supervision, design experimental plans and analyze resulting data
  • Capable of prioritizing tasks independently and applying experience to effectively plan and achieve objectives

Responsibilities

  • Formulate standard to complex biochemical and chemical reagents in accordance with manufacturing records, Standard Operating Procedures, and Quality System regulations
  • Perform antibody-oligo conjugations on Hamilton platforms
  • Execute lyophilization of critical components for downstream manufacturing
  • Assist in other manufacturing activities deemed high priority such as filling and packaging, label printing, and special builds, etc
  • Perform batch records review and sign off to ensure completeness and compliance to Quality System standards
  • Support production scheduling and assignment of job duties to team members
  • Provide training, mentoring, and coaching to team members with similar or less experience
  • Address and investigate production issues and report any compliance related concerns to supervisor and/or management as soon as possible
  • Ensure equipment and instruments are current with calibration and preventive maintenance, and general maintenance
  • Participate in verification and validation to transfer new products/processes from R&D into Manufacturing, including executing on protocols, gathering data and/or report generation
  • Initiate process improvement projects to improve productivity, quality, cost, or yield
  • Draft, review, or revise manufacturing documents and procedures
  • Perform change management as required to support product and process change and document change
  • Participation in the selection and training of new employees
  • Act as Lead when Specialist/Supervisor is unavailable
  • Participate in internal and external safety and quality inspections
  • Enforce a safe working environment and compliance with all safety laboratory practices

Skills

ISO 13485
cGMP
SOPs
Reagent Formulation
Process Optimization
Troubleshooting
Biochemical Reagents
Chemical Reagents
Manufacturing

Alamar Biosciences

Develops technology for protein detection and measurement

About Alamar Biosciences

Alamar Biosciences focuses on the study of proteins, known as proteomics, to enhance disease detection and treatment. The company has created NULISA™, a technology that can detect and measure proteins in the human body with high sensitivity and a wide range. This allows researchers and clinicians to profile clinically relevant protein biomarkers, which are essential for developing new diagnostic tests and treatments for various diseases. Alamar's ARGO™ system complements NULISA™ by providing a fully automated, high-throughput platform for precision proteomics. Unlike competitors, Alamar's technology simplifies the process, reducing the need for extensive technical expertise, making it more accessible to clients. The goal of Alamar Biosciences is to improve our understanding of proteins in health and disease, ultimately leading to better early detection and treatment options.

Hayward, CaliforniaHeadquarters
2018Year Founded
$225.7MTotal Funding
GRANTCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees

Benefits

401(k) Company Match
401(k) Retirement Plan
Performance Bonus
Company Equity

Risks

Increased competition from Olink and SomaLogic may impact Alamar's market share.
Scaling production in Europe and APAC could strain resources and affect quality.
Regulatory hurdles in new regions may delay product launches and affect revenue.

Differentiation

Alamar's NULISA™ technology offers unprecedented sensitivity in protein detection.
The ARGO™ system automates high-throughput proteomics, reducing the need for technical expertise.
Alamar's focus on early disease detection sets it apart in the biotechnology field.

Upsides

ISO 13485:2016 certification boosts Alamar's credibility in the medical device industry.
European expansion with Milan headquarters enhances market reach and client service.
$10M investment accelerates Alzheimer's diagnostics development, strengthening Alamar's market position.

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