Senior Manufacturing Associate

Alamarbiosciences; Fremont (CA); On-site; USD 85,000 - 100,000; Full time

Job summary

Alamar is seeking a Senior Manufacturing Associate for the second shift to join our Operations team in a fast-paced biotechnology setting in Fremont, CA. You will handle antibody processing, lyophilization, and conformity with SOPs and Quality Systems.

This role requires 6+ years in reagents manufacturing, strong autonomy, and the ability to mentor junior staff while maintaining safety and quality standards. A base salary is offered with bonus, equity, and benefits.

Qualifications

• BS in Biology or Chemistry with 6+ years in reagents manufacturing.
• Strong verbal and written communication skills.
• Experience with ISO 13485 / GMP environment and ERP systems a plus.

Responsibilities

• Perform processing and conjugation of antibodies and lyophilization of critical components.
• Formulate reagents per manufacturing records, SOPs, and Quality System regulations.
• Assist in filling, packaging, label printing, and special builds as needed.
• Perform batch records review and sign off to ensure Quality System compliance.
• Support production scheduling and assign job duties to team members.
• Provide training, mentoring, and coaching to team members.
• Address and investigate production issues and report compliance concerns.
• Ensure calibration and maintenance of equipment; participate in transfer of new products from R&D to Manufacturing.
• Draft, review, or revise manufacturing documents; participate in change management for product/process changes.

Skills

Autonomy

Strong communication

Multi-tasking

Organizational skills

Team player

Leadership

Data analytics

Education

B.S./B.A. in Biology or Chemistry

Tools

Manufacturing software

ERP system

Databases

Job description

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.

We are seeking a highly disciplined and results-driven candidate to join our Operations team as Senior Manufacturing Associate in a second shift. Senior Manufacturing Associate handles various Manufacturing assignments ranging from routine to complex, requiring sound judgment to solve issues, identify areas for enhancement, and suggest improvements. Capable of working independently by following standard operating procedures (SOPs) with moderate training and may establish methods and approaches for new tasks and offer support or direction to other junior team members. Act as Subject Matter Expert with a strong understanding of standard principles, techniques, and practices in Manufacturing and can leverage their technical expertise to support troubleshooting and continuous process optimization. Capable of prioritizing tasks independently and apply their experience to effectively plan and achieve objectives. Experience working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry is highly preferred.

Work Schedule

10 am to 6:30 pm Thursday, Friday, Saturday, Sunday, and Monday.

Second Shift Expectations

• Minimal supervision is provided over the weekend; candidates must demonstrate extensive experience working independently and making sound decisions in a manufacturing environment.
• Ability to troubleshoot and resolve complex technical issues autonomously, escalating only when necessary.
• Provide guidance to junior staff as needed.
• Strong organizational skills and self‑motivation are essential to maintain productivity and quality standards during off‑hours.
• Effective communication skills to provide regular updates and document activities for review by weekday supervisors.
• Commitment to safety, quality, and continuous improvement, even when working independently.

Responsibilities

• Perform processing and conjugation of antibodies and lyophilization of critical components for downstream manufacturing.
• Formulate standard to complex biochemical and chemical reagents in accordance with manufacturing records, Standard Operating Procedures, and Quality System regulations.
• 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.

Required Qualifications

• A B.S. or B.A. degree in Biology, Chemistry or equivalent with 6+ years of relevant experience in reagents manufacturing. Experience in lyophilization highly preferred.
• Strong verbal and written communication skills.
• Able to work and deliver expected results with a high degree of autonomy.
• Ability to handle multiple tasks and highly adaptive to changing priorities and deadlines.
• Strong organizational skills, detail oriented, and problem-solving skills.
• Must be a strong team player, self‑motivated with “can do” attitude, and willing to learn new techniques and concepts in a fast‑paced environment.
• Effective leadership and collaboration skills and the ability to work cross‑functionally across categories and internal stakeholders.
• Strong proficiency with Microsoft Office suite and experience using manufacturing software, databases and data analytics tools.
• Experience in ISO 13485 and GMP environment a plus.
• Previous experience with ERP System preferred.

Physical Requirement

• Able to lift up to 25 lbs.
• Position requires working in a standing position for long periods of time on a daily basis.

The base salary range for this full-time position is $85,000 - $100,000 + 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.

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