Lead Manufacturing Specialist - Lyophilization

Back to jobs Lead Manufacturing Specialist - Lyophilization Fremont, CA Apply At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world’s most sensitive proteomics platform to unmask the deepest secrets of our proteome. Our fully automated, high throughput platform will empower new biomarker discoveries for early detection and prevention of common diseases. We provide exceptional opportunities for those who have the entrepreneurial spirit, enjoy developing novel technologies and products, and aspire to grow together with the company.   Description: We are seeking an experienced, detailed oriented, and results-driven candidate to join our Operations team as Lead Manufacturing Specialist - Lyophilization.  This position acts 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.  In addition, this position is also responsible for planning and executing lyophilization to meet production demand and overseeing other Manufacturing Associates in lyophilization.  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. Responsibilities: Lead, plan, and perform production activities for lyophilization Provide technical support for any lyophilization process-related issues Responsible for revising and originating production records, standard operating procedures, protocols and reports; initiates and closes out deviation reports and change requests Ensure lyophilization equipment is in controlled state to sustain manufacturing and ensure routine PM is executed on time Perform investigation and troubleshooting of technical issues in lyophilization with the identification and implementation of corrective actions. Collaborate with Product Development team to transfer new processes to manufacturing and generate production records and SOPs in compliance with ISO 13485 Generate risk assessments and mitigation plans when processes are transferred to Manufacturing Facilitate continuous improvement of processes to increase efficiency, improve quality, and promote sustainability Train new manufacturing staff on procedures, aseptic techniques, equipment, and trouble-shooting skills Coordinate with Facilities, QC and R&D to complete all pre- and post-production activities Perform final review of manufacturing MPRs for accuracy and filing of records Adhere to best safety practices and documented procedures to ensure a safe working environment Required Qualifications Bachelor’s degree or above in biological sciences, chemical engineering or related discipline 7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent experience, with 4+ years of hands on experience in lyophilization Knowledge of Good Manufacturing Practices Can follow/interpret SOPs and train manufacturing staff in lyophilization Good analytical skills to interpret manufacturing data and understand production problems Experience with process development, transfer and optimization preferred Mechanical aptitude on performing troubleshooting and PM on lyophilizers preferred Experience with execution of validation protocols is a plus Excellent communications skills and good attention to detail Ability to work in fast paced, dynamic, team environment Ability to handle multiple projects at one time 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.   Apply for this job * indicates a required field First Name * Last Name * Email * Phone Resume/CV Attach Attach Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Will you now or in the future require sponsorship to work within the United States? * Select... If yes, please specify? How did you hear about this job? Are you able to come onsite to South Fremont, CA daily? * Select... Do you have at least 4 years of experience with lyophilization? * Select... What is your salary requirement? * Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Alamar Biosciences’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Submit application