Sr. Scientist HPLC Lead
$140k - $170kFull-time
Asahi Kasei America, Inc.
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Company:
Bionova Scientific LLC Job Description: Partnering closely with the Senior Director of Quality Control, the Sr. Scientist HPLC Lead will help support the establishing efficient, compliant, and high-performing laboratory operations with a focus on HPLC and CE in a regulated GMP environment. This role requires deep expertise in all aspects of HPLC testing and a sound understanding in CDS software, preferably Empower, Quality Control GMP operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments. Location: Fremont, CA Position Responsibilities:
Bionova Scientific LLC Job Description: Partnering closely with the Senior Director of Quality Control, the Sr. Scientist HPLC Lead will help support the establishing efficient, compliant, and high-performing laboratory operations with a focus on HPLC and CE in a regulated GMP environment. This role requires deep expertise in all aspects of HPLC testing and a sound understanding in CDS software, preferably Empower, Quality Control GMP operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments. Location: Fremont, CA Position Responsibilities:
- Serve as an HPLC subject matter expert and drive improvement of HPLC workflows and our Empower based CDS.
- Author and maintain analytical methods, validation and qualification documentation, and relevant laboratory procedures.
- Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein
- Support troubleshooting and transfer tests from Analytical Development into GMP operations.
- Review and interpret analytical data to identify trends, assess risk, and initiate appropriate corrective actions.
- Lead investigations for deviations, including OOS, OOT, OOR, and OOE, performing root cause analysis and defining corrective and preventive actions.
- Act as a subject matter expert during client audits and regulatory inspections, representing QC analytical and operational processes.
- Implement Lean laboratory practices and drive continuous improvement to enhance efficiency and performance.
- Support cross-functional QC activities by providing cross-trained resources to address urgent analytical needs.
- Lead, coach, and develop a team of analysts to ensure high technical and performance standards.
- Establish and maintain compliant laboratory operations aligned with Bionova quality standards and regulatory requirements, including the definition and monitoring of key performance indicators.
- Bachelor of Science degree or equivalent in a scientific field
- Minimum of 8-10+ years of experience in analytical or quality control environments. Minimum of 3 years of GMP Quality Control Laboratory.
- Strong working knowledge of HPLC and CE analytics with expertise in method development and GMP validation.
- Experience in designing CDS workflows (data review, audit trails, design of workflows, custom fields...)
- Expertise in data analysis, trend analysis, and statistical methods.
- Excellent written and verbal communication skills to effectively document findings and present technical information.
- Working knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex etc.)
- Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events
- Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, or equivalent systems)
- Effective interpersonal and communication skills. Communication at all management levels and all staff is required.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Sr. Scientist HPLC Lead in Fremont, CA vacancy
$140k - $170k
...Company: Bionova Scientific LLC Job Description: Partnering closely with the Senior Director of Quality Control, the Sr. Scientist HPLC Lead will help support the establishing efficient, compliant, and high-performing laboratory operations with a focus on HPLC...HPLCSeniorFull timeWork at officeAsahi Kasei Plastics North America, Inc.
Fremont, CA5 days ago$150k - $160k
Sr. Scientist, Analytical Development and Quality Control - Permanent - East Bay AreaReady to play... ...Analytical DevelopmentExpertise in UHPLC/HPLC method development and... ...Sr. Scientist's responsibilities will be:Lead analytical development activities for drug...HPLCSeniorPermanent employment- Proclinical is seeking a Sr. Scientist, Analytical Development & Quality Control in the East Bay Area to provide analytical... ...substance and drug product development. You will lead method development/validation (UHPLC/HPLC, LC-MS), oversee external laboratories, and ensure...HPLCSenior
$140k - $160k
Position: Senior Scientist, Bioanalytical Development Location: Newark, CAJob Id: 427 #... ...ResponsibilitiesOperate and maintain analytical instrumentation such as HPLC, mass spectrometer, and other lab equipmentPrepare reagents,...HPLCSeniorFull timeTemporary workWork at officeWorldwideFlexible hours- ...Crown Laboratory Company) is seeking a Sr. Associate Scientist to contribute to our Analytical... ...common characterization techniques such as HPLC, AUC, SEC‑MALS, MFI, DLS, and CD. Experience... ...producing, and distributing industry‑leading, differentiated products across...HPLCSeniorContract workFor contractorsLocal area
- Personalis, Inc in Fremont, CA seeks a CLS Supervisor to lead clinical laboratory testing, supervise staff, and ensure strict compliance with specimen handling, NGS processes, and patient record maintenance. You will work across extractions, library preparation, and sequencing...Senior
$130k - $150k
...ATUM ( is a 20-year-old, world-leading bioengineering company of ~150 people. We conduct... ...of clients across the globe. This is a scientist position in our protein analytics lab, where... ...proficiency in key analytical techniques, such as HPLC, binding assays, ELISA, and LC-MS....HPLCFull timeShift workAtum - DNA 2.0
Newark, CA2 days ago$120k
...FDA/EMA and cGMP regulations. Develop, validate, and transfer analytical methods as needed, troubleshoot instrumentation such as HPLC, UPLC and GC. Train and mentor junior analysts, and interface with clients or regulatory authorities. Skills required Deep...HPLCFull timeNova Pneuma, Inc.
Fremont, CA27 days ago- Bio-Techne is seeking an Advanced Research Associate to develop new spatial biology products and improve existing assays based on ISH/IHC. You will design and execute experiments, analyze data, and present findings to the R&D team, while contributing to technical reports...
- ...Assurance. You will develop analytical methods, oversee GC-MS, LC-QTOF, HPLC, and atomic absorption, manage calibration records, QA... ...documentation and instrument maintenance. You will also generate reports and lead LIMS initiatives. Responsibilities include water quality testing...HPLC
- ...a passion for success - join us today! UCT is looking for a talented Senior Research Chemist/Scientist to join us in Fremont, CA! The Senior Research Chemist/Scientist leads advanced research, formulation, and characterization activities that enable new materials, chemistries...Senior
- BillionToOne is seeking a Clinical Laboratory Scientist with a California CLS license to join our onsite CLIA laboratory in Union City, CA. You will perform UNITY, our non-invasive prenatal test, and support end-to-end processing of pregnancy samples in a high-growth environment...Shift work
- ...Analytical Chemist (Contract to Perm) for an onsite role in Pleasanton, CA. You will lead hands-on analytical development to advance next-generation formulation platforms, focusing on robust HPLC/UPLC methods and early-stage validation. The ideal candidate has 7-10 years in...HPLCPermanent employmentContract work
- Oryx Advanced Materials is seeking a Lead Analytical Chemist to own and operate the analytical chemistry laboratory. This hands-on role requires instrument operation, method development, and CoA generation while ensuring audit-ready quality systems. The ideal candidate...
- Oryx Advanced Materials Inc is seeking a Lead Analytical Chemist to own our analytical lab, operate ICP-OES and LECO instruments, and develop testing methods for metals and advanced materials. You will manage lab workflows, ensure audit-ready records, and generate CoAs...
- ...operator of lab equipment to ensure beverage product integrity. Responsibilities include expanding testing capabilities for GCMS, LC-QTOF, HPLC, and atomic absorption, managing water quality data across facilities, updating SOPs, and supporting production with #J-18808-...HPLC
- We are seeking a talented Scientist I to join the Assay Productization team to support the development... ...projects under guidance from an AP lead. Perform troubleshooting of failed... ...with analytical techniques including qPCR, HPLC, Enzymatic Assays, and instrumentation such...HPLC
- We are seeking a highly motivated Scientist, Reagent R&D and Manufacturing to join our growing team developing innovative molecular diagnostic... ...purification. Familiarity with analytical techniques such as HPLC, UV‑Vis spectroscopy, electrophoresis, qPCR, and biochemical...HPLC
- Personalis is seeking a CLS Supervisor to oversee clinical laboratory testing, reporting, and QA processes in a fast-paced environment. The role includes supervision of team members, ensuring proper specimen handling, NGS workflows, and accurate patient record maintenance...Night shift
- Personalis, Inc. in Fremont, CA is seeking a CLS Supervisor to lead clinical laboratory testing, including extractions, library preparation, and sequencing to support diagnostic decisions. The role requires a California CLS or CGMBS license, a bachelor’s degree in sciences...Shift workNight shift
$140k - $160k
Position: Senior Scientist, Analytical Development & Quality Control Location: Newark, CAJob Id: 426... ...drug substance (DS) and drug product (DP). This role includes leading internal analytical activities, managing external CDMO partners...SeniorFull timeTemporary workWork at officeWorldwideFlexible hours$155.2k - $232.8k
Sr. Concrete Admixture R&D Lead page is loaded## Sr. Concrete Admixture R&D Leadlocations: Fremont, CAtime type: Full timeposted on: Posted Todayjob... ...U.S. and Europe and expanding our team of engineers, scientists, and innovators.Apply now to join our team and be part...SeniorRelocation- ...emphasis on beverage and flavor specific methods on GCMS, LC-QTOF, HPLC, Flame Atomic Absorption, and bench top meters. These will... ...integration and effective deployment 6. Support production facilities and lead root cause analysis investigations for troubleshooting purposes...HPLCFull timeWork at officeFlexible hours
$150k - $210k
...support studies and validations, QC release and stability programs, lead OOS/OOT investigations, author and defend CAPAs, and partner... ...operations or analytical quality functions. Hands-on proficiency with HPLC, LC-MS, and UV-based analytical methods relevant to peptide API...HPLCSeniorContract workShift work- Waters seeks a Scientist/Manager for the Single Cell Multiomics team to develop and support BD Rhapsody assay products. You will work with scientists to advance molecular biology and NGS-based solutions, communicating across disciplines to drive product launches and platform...
- ...Corporation in Milpitas, CA, is seeking a senior molecular biologist to lead assay development for the BD Rhapsody platform, with emphasis... ..., and tech transfer support. You will collaborate with wet lab scientists and bioinformatics teams, analyze single-cell genomics data,...
- Sr Salesforce Developer Location: San Jose/Fremont/Sunnyvale, CA (Hybrid) Job Details We are looking for a seasoned Salesforce Developer who: Can write high-quality, production-ready code. Has deep practical experience with Apex, LWC, and DevOps tools. Is aligned with...Senior
- Atum - DNA 2.0 in Newark, CA seeks a bench-heavy Senior Scientist to join our Cell Line Development team. The role emphasizes hands-on molecular biology, CRISPR/editing, vector design, and host cell engineering to advance CHO lines for protein production. The ideal candidate...Senior
- Protagonist Therapeutics is seeking a talented Senior Scientist to join the Analytical Development & Quality Control (ADQC) group in Newark... ..., transfer, and stability programs for DS and DP. You will lead internal activities and manage CDMO partnerships to achieve program...Senior
$120k - $150k
...a leader in cell line development, gene synthesis, and protein engineering. We are seeking a highly motivated, bench-heavy Senior Scientist to join our Cell Line Development (CLD) team. This is a hands-on, high-impact laboratory role focused on applying deep, foundational...SeniorFull timeAtum - DNA 2.0
Newark, CAa month ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Scientist HPLC Lead. Be the first to apply!
Related searches
- applied scientist Fremont, CA
- operations research scientist Fremont, CA
- applied sports scientist Fremont, CA
- health scientist Fremont, CA
- drug safety scientist Fremont, CA
- scientist biology Fremont, CA
- safety scientist Fremont, CA
- machine learning research scientist Fremont, CA
- application scientist Fremont, CA
- materials scientist Fremont, CA