Sr. Manufacturing Associate at Alamar Biosciences

Fremont, California, United States

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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

Key technologies and capabilities for this role

ISO 13485cGMPSOPsReagent FormulationProcess OptimizationTroubleshootingBiochemical ReagentsChemical ReagentsManufacturing

Questions & Answers

Common questions about this position

What experience is preferred for this Senior Manufacturing Associate role?

Experience working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry is highly preferred.

What are the key responsibilities of the Senior Manufacturing Associate?

Responsibilities include formulating biochemical and chemical reagents, performing antibody-oligo conjugations on Hamilton platforms, executing lyophilization, assisting in filling and packaging, batch records review, supporting production scheduling, training team members, investigating production issues, and ensuring equipment maintenance.

What is the company culture like at Alamar Biosciences?

The culture rewards accountability and cross-functional teamwork, seeking collaborative, driven, intellectually curious people committed to solving complex challenges to accelerate the mission.

Is remote work an option for this position?

This information is not specified in the job description.

What makes a strong candidate for this role?

A strong candidate is highly disciplined, energetic, results-driven, capable of working independently following SOPs, acting as a Subject Matter Expert in Manufacturing, supporting troubleshooting and process optimization, and providing training to junior team members.

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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