Sr. Specialist QC / Sr. Scientist QC
$113k - $150kFull-time
Bionique Testing Laboratories LLC
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: Bionova is seeking an experienced and technically strong QC Sr. Specialist / Scientist to provide advanced analytical expertise, hands-on laboratory support, and scientific leadership in support of our expanding business. As a senior member of the growing QC team, this role will help guide and execute complex assay work, coach and develop analysts, lead troubleshooting efforts, and contribute to robust technical solutions that support project delivery and ultimately improve patient outcomes. Location: Fremont, California Bionova B1 building 3100 W. Warren ave, Fremont, CA 94538 Direct hire - Full Time Company Summary: 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. Essential Duties and Responsibilities:
Bionova Scientific LLC Job Description: Bionova is seeking an experienced and technically strong QC Sr. Specialist / Scientist to provide advanced analytical expertise, hands-on laboratory support, and scientific leadership in support of our expanding business. As a senior member of the growing QC team, this role will help guide and execute complex assay work, coach and develop analysts, lead troubleshooting efforts, and contribute to robust technical solutions that support project delivery and ultimately improve patient outcomes. Location: Fremont, California Bionova B1 building 3100 W. Warren ave, Fremont, CA 94538 Direct hire - Full Time Company Summary: 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. Essential Duties and Responsibilities:
- Provide senior-level technical oversight and hands-on execution support for cell-based assays, ELISA, and qPCR testing, including method qualification, validation, transfer, release, in-process, and stability support in a GMP environment.
- Provide subject matter expertise for analytical methods, SOPs, protocols, technical assessments, and QC documentation to ensure scientifically sound and compliant execution.
- Coach analysts on GMP documentation, data review, assay execution, and scientific rationale to build technical capability and strengthen compliance within the QC team.
- Lead complex troubleshooting for assay performance, instrumentation, invalid results, atypical trends, equipment issues, and laboratory readiness.
- Support deviations, CAPAs, change controls, regulatory inspections, and observation responses with clear technical analysis, defensible conclusions, and practical remediation strategies.
- Identify and lead continuous improvement initiatives to improve assay robustness, laboratory efficiency, testing continuity, right-first-time execution, and inspection readiness.
- This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
- BS in Biological Sciences or related discipline with 5-7 years of bioassay and/or ELISA experience, including 3-5 years in a regulated QC GMP laboratory environment.
- Strong hands-on expertise with bioassay, ELISA, qPCR, SpectraMax, and QuantStudio platforms, including method validation, transfer, technical investigations, and troubleshooting.
- Strong understanding of GMP, GDP, Data Integrity, ALCOA+, global regulatory guidelines, and quality systems including deviations, CAPA, and change control.
- Ability to interpret SOPs, protocols, regulatory requirements, and complex data; recognize trends; develop scientifically justified conclusions; and communicate recommendations clearly.
- Demonstrated ability to work independently as a senior technical contributor, coach less experienced analysts, influence cross-functional teams, and drive complex issues to resolution.
- Effective verbal and written communication skills, with proficiency in Microsoft Office Suite.
Vacancy posted 6 days ago
Similar jobs that could be interesting for youBased on the Sr. Specialist QC / Sr. Scientist QC in Fremont, CA vacancy
- ...assay-ready products. You will execute cell-based assays under aseptic conditions, assist with process transfers to Cell Production and QC, and help implement Master/Working Cell Bank workflows. The role requires B.S. or M.S. in life sciences with 2+ years of industrial...Suggested
$140k - $160k
Position: Senior Scientist Analytical Development & Quality Control Location: Newark, CAJob Id: 414... ...effectively with stakeholders and manage analytical development and QC testing activities at CDMOs.Review CDMO data for release testing...SeniorWorldwide- Alamarbiosciences is looking for a highly motivated Sr. Scientist I in Fremont, California, to join the Product Development team. This role is centered on QC method development, ensuring products are robust and manufacturable, while supporting New Product Introduction....Senior
- Bionova Scientific LLC, a subsidiary of Asahi Kasei, seeks a QC Senior Specialist/Scientist to provide advanced analytical expertise and hands-on lab support in Fremont, CA. You will lead assay work (ELISA, qPCR), mentor analysts, troubleshoot complex issues, and contribute...Senior
- Bionova Scientific LLC is seeking a QC Sr. Specialist/Scientist to provide advanced analytical expertise and lead complex assay work in Fremont, CA. You will coach analysts, drive method qualification/validation and support transfer, release, and stability testing in a...Senior
- Alamarbiosciences seeks a highly skilled Sr. QC Scientist I for the Operations team, starting with a 6-month onboarding in Product Development. After training on the NULISAseq platform, you will lead QC, troubleshooting, and batch release for antibody pools, ensuring high...Senior
- Alamar Biosciences, Inc. seeks a Sr. QC Scientist I to join the Operations team, starting with a 6-month onboarding within Product Development. You will own building, QC, and troubleshooting for NULISAseq antibody pools, bridging scientific rigor with manufacturing discipline...Senior
$150k - $165k
Position Summary We are seeking a highly motivated Sr. Scientist I to join the Product Development team supporting New Product Introduction... ...This role focuses on downstream product development, including QC method development, analytical strategy, process optimization,...SeniorFull time$150k - $165k
...enables the kind of breakthrough thinking that will accelerate our mission. We are seeking a highly skilled and quality-driven Sr. QC Scientist I to join our Operations team in a role that begins with an intensive 6-month onboarding period embedded within our Product...SeniorFull time$150k - $165k
...that will accelerate our mission. Position Summary The Senior Scientist I - IVD Assay Development will lead the design, development, optimization... ...assay designs to tech transfer and manufacturing; define QC measures and support scale‑up activities Work closely with...SeniorFull time- Bionova Scientific LLC in Fremont, CA is seeking a Senior QC Specialist/Scientist to provide advanced analytical expertise in cell-based assays, ELISA, and qPCR within a GMP environment. You will mentor analysts, troubleshoot complex assay issues, and drive continuous improvement...Senior
- Boehringer Ingelheim GmbH in Fremont, CA seeks a Sr Specialist, QC Lab General to lead non-routine method transfers and validations in a GMP environment. The role covers technical assessments, QA ownership for new methods, and group representation on equipment qualifications...Senior
- ...cancer care. Position Overview: The (Senior) Bioinformatics Scientist, Clinical Data Science and Data Management will support clinical... ..., including data plans, integration, cleaning, reconciliation, QC, and analysis-ready dataset generation.20% Reporting & Workflow...SeniorWork experience placementImmediate startWorldwide
Predicine
Hayward, CA6 days ago $120k - $140k
...investors. Job Summary We are looking for a highly motivated Senior Scientist, Surface Chemistry to lead R&D and process development for... ...robust operating windows and control plans Build Quality Control (QC) workflows, including metrology panels, acceptance criteria, and...SeniorFull timeFlexible hours- 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
- Alamar Biosciences is seeking a Sr. QC Scientist I to join the Operations team, starting with a 6‑month onboarding in Product Development. You will lead the QC for NULISAseq antibody pools, perform in‑process and finished goods QC, and drive root cause analyses to uphold...Senior
- ...Summary: Revance (a Crown Laboratory Company) is seeking a Sr. Associate Scientist to contribute to our Analytical Development team. The Sr. Associate... ...with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing...SeniorContract workFor contractorsLocal area
- .... Position Summary We are seeking a highly motivated Associate Scientist II to join the Product Development team supporting New Product Introduction... ...lyophilization development, reagent characterization, and QC testing. The successful candidate will play a key role in...
- Alamar Biosciences, Inc. is seeking a highly motivated Associate Scientist I to join the Product Development team supporting New Product... ...emphasis on supporting verification and validation (V&V) studies, QC method development, and troubleshooting to generate high-quality...
$85k - $97k
Associate Scientist I, Product Development Fremont, California At Alamar, we are passionate about enabling our customers to make scientific... ...on supporting verification and validation (V&V) studies, QC method development, and troubleshooting activities by executing...Full timeContract workFor contractorsFor subcontractorWork at office$155k - $190k
...Sr. Bioinformatics Scientist - DNA Technology Development & Applied AI Fremont, CA Days Onsite: Monday & Tuesday Summary: The Bioinformatics Senior Scientist will work with a world‑class, dynamic team of bioinformatics scientists, software engineers, and laboratory scientists...SeniorFull timePersonalis
Fremont, CA3 days ago- ...transcriptomic readouts routine, quantitative, and scalable - so scientists can ask harder questions and trust the answers. We are looking... ...tissue - dissociation, viability and debris management, and input QC - optimized for compatibility with the Themis scRNA-seq...SeniorShift work
- ...the role: We are looking for an exceptional, multidisciplinary scientist to drive new research and product development efforts in our Spatial... .... Extensive experience working with antibodies, including mAb QC, conjugation, functional testing. Strong analytical background...SeniorFull time
$125k - $135k
...15 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description The Senior Scientist, Analytical Development is responsible for designing and developing cell-based bioassays for supporting characterization, and potency...SeniorFull timeContract workMonday to FridayEurofins USA Discovery Services
Fremont, CA20 days ago- ...Fertilization (IVF), fertilization of eggs, Intracytoplasmic Sperm Injection (ICSI), Assisted Hatching (AH), sperm and specimen preparation, QC, embryo culturing, embryo evaluation and monitoring, cryopreservation of embryos, eggs and sperm and cryostorage of embryos, eggs and...Hourly payImmediate startWeekend work
Kaiser Permanente
Fremont, CA4 days ago $35 - $40 per hour
...closely with R&D to ensure smooth, efficient, and successful execution of new bioassay assay process transfer to Cell Production and QC. Help to implement Master Cell Bank (MCB) and/or Working Cell Bank (WCB) process flow and related SOPs. Perform Mycoplasma and Sterility...Full timeMonday to FridayShift workEurofins
Fremont, CA4 days ago- ...Summary We are seeking a highly motivated senior bioinformatics scientist to support NGS-based liquid biopsy studies and translational... ...statistical models, and machine-learning approaches for sequencing QC, variant analysis, and study-specific analyses, while...SeniorFull timeWork experience placementImmediate startWorldwide
Predicine
Hayward, CA7 days ago - Personalis, Inc. in Fremont, CA is hiring a Clinical Laboratory Scientist to perform and report clinical lab testing for cancer diagnostics and MRD profiling. You will follow procedures and collaborate with physicians, with responsibilities across pre- and post-analytical...Night shift
- Aspect Biosystems in Fremont, CA is seeking an enthusiastic Scientist for its Quality Control & Analytical Development team. You will lead... ...bioprinted tissue therapeutics. The role requires collaboration across QC, Process Development, and R&D to advance programs toward...
- Aspect Biosystems in Fremont, California seeks a Scientist to join the Quality Control & Analytical Development team to advance cell-based... ...ensure GxP compliance; and collaborate with Process Development, QC, Research & Development, and Manufacturing to support product...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Specialist QC / Sr. Scientist QC. Be the first to apply!
Related searches
- authorization specialist Fremont, CA
- treasury specialist Fremont, CA
- wellness specialist Fremont, CA
- helpdesk specialist Fremont, CA
- program eligibility specialist Fremont, CA
- performance improvement specialist Fremont, CA
- international relations specialist Fremont, CA
- accessibility specialist Fremont, CA
- remote outreach specialist Fremont, CA
- veteran specialist Fremont, CA