Lead Manufacturing Associate - Lyophilization at Alamar Biosciences, Inc.

<div class="content-intro"><p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">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.</span></p></div><p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Description:</strong></span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">We are seeking an experienced, detailed oriented, and results-driven candidate to join our Operations team as Lead Manufacturing Associate - Lyophilization.&nbsp; This position act as the subject matter expert to commission new lyophilizers, train Manufacturing staff, drive continuous improvements for processes and equipment related to lyophilization and transfer of new products/processes into routine manufacturing.&nbsp; In addition, this position is also responsible for planning and executing lyophilization to meet production demand and overseeing other Manufacturing Associates in lyophilization.&nbsp; Experience in production planning and working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry is highly preferred.</span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Responsibilities:</strong><strong>&nbsp;</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Lead, plan, and perform production activities for lyophilization</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Provide technical support for any lyophilization process-related issues</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Responsible for revising and originating production records, standard operating procedures, protocols and reports; initiates and closes out deviation reports and change requests</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ensure lyophilization equipment is in controlled state to sustain manufacturing and ensure routine PM is executed on time</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Perform investigation and troubleshooting of technical issues in lyophilization with the identification and implementation of corrective actions.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Collaborate with Product Development team to transfer new processes to manufacturing and generate production records and SOPs in compliance with ISO 13485</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Generate risk assessments and mitigation plans when processes are transferred to Manufacturing</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Facilitate continuous improvement of processes to increase efficiency, improve quality and promote sustainability</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Train&nbsp;new&nbsp;manufacturing staff on procedures, aseptic techniques, equipment and trouble-shooting skills</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Coordinate with Facilities, QC and R&amp;D to complete all pre- and post-production activities</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Perform final review of manufacturing MPRs for accuracy and filing of records</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Adhere to best safety practices and documented procedures to ensure a safe working environment</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Required Qualifications:</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Bachelor’s degree or above in biological sciences, chemical engineering or related discipline.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent experience with minimum 4 years of hands-on experience in lyophilization.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Knowledge of Good Manufacturing Practices.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience in formulation and scale up.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Good analytical skills to interpret manufacturing data and understand production problems.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience with process development, transfer and optimization preferred.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Mechanical aptitude on performing troubleshooting and PM on lyophilizers preferred.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Excellent communications skills and good attention to detail.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ability to work in fast paced, dynamic, team environment.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ability to handle multiple projects at one time.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Proficient in MS Office (Word, Excel, and PowerPoint).</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Preferred Qualifications:</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Hands‑on familiarity with process characterization, scale‑up, and validation readiness activities (e.g., support of IQ/OQ/PQ planning or execution).</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Practical experience driving or supporting continuous improvement initiatives within a manufacturing or operations organization.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Demonstrated ability to lead cross‑functional teams by influence, aligning Manufacturing, Quality, Engineering, and Supply Chain toward shared objectives.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>Physical Requirement:</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Ability to lift up to 25 lbs.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Routine presence on the manufacturing floor, including extended standing or walking as required.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">The base salary range for this full-time position is $110,000 - $130,000 + 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.&nbsp;</span></p>