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Quality Control Scientist jobs at AGC Biologics

- 5 jobs
  • Scientist III - Analytical Chemist - FSP

    Parexel 4.5company rating

    Olympia, WA jobs

    We are looking to fill a **Scientist 3 - Analytical Chemist** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $90k-121k yearly est. 60d+ ago
  • Scientist

    Roche 4.7company rating

    Seattle, WA jobs

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position SCIENTIST (Oligo Synthesis) - SBX MOLECULAR ENGINEERING A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. We advance science so that we all have more time with the people we love. Roche Diagnostics acquired Stratos Genomics (********************************* in 2020 for its unique chemistry that advances DNA sequencing by nanopore, Sequencing by Expansion (SBX™). You will engineer and synthesize the molecular building blocks for our novel technology. These building blocks translate DNA sequences into a simple to measure surrogate, the Xpandomer, which significantly improves the accuracy and throughput of nanopore sequencing. The Molecular Engineering group is passionate about the novel molecules they have developed and the impact SBX technology can have on advancing sequencing and patient outcomes. We are looking for people who are excited about the significance of our technology and want to make SBX successful. ***Please include a cover letter outlining why you want to work with us, your specific interest in SBX technology (technical) and how you would contribute, this is important.*** The Opportunity: Research, design and execute innovative and well-controlled experiments, with high attention to detail. Identify and troubleshoot problems in creative ways. Contribute to the definition and timely achievement of project goals. Follow SOPs to aid in the production of reagents and starting materials Participate in the production of reagents and starting materials. Perform data analysis and protocol development. Maintain accurate, detailed and reliable laboratory records. Present findings at group or departmental meetings. Maintain the lab's cleanliness and organization. Develop and propose improved processes to fulfill the above functions. Who You Are: You have a minimum of 2 years laboratory experience in advanced oligo synthesis (e.g. use and development of non-standard phosphoramidites and reagents, branched or cyclic structures, and instrument modification) You hold a Bachelor's degree in Organic Synthesis, Chemistry, Chemical Engineering, Biochemistry or related field; or equivalent combination of education and work experience, MS or PHD Preferred. 5+ years of experience, less with advanced degrees. Ideally, you will have: Demonstrated ability to understand and develop novel chemistry for automated oligo synthesis: Coupling of Phosphoramidites Oxidation Detritylation Capping Able to manipulate and engineer novel solutions with complex automated fluidics (i.e. Automated Oligo Synthesizers) Mature understanding of how to work with chemical and biochemical samples, including sample handling, reactivity, purification and storage. Technical background in next-generation DNA sequencing Experience with HPLC, MS, NMR, inert atmosphere chambers, and manual pipetting. Relocation benefits are available for this posting . The expected salary range for this position based on the primary location of Seattle, WA is 81,100.00 - 150,700.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed here: Benefits Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $64k-103k yearly est. Auto-Apply 55d ago
  • Scientist, Potency and Functional Characterization

    Bristol Myers Squibb 4.6company rating

    Seattle, WA jobs

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary We are seeking a highly motivated professional to join the Cell Therapy Analytical Development team, specializing in cell line engineering and potency method development for viral vector applications. The ideal candidate will contribute to the optimization and qualification of cell-based viral vector transduction assays measured by flow cytometry and luminescent reporter genes. This position demands a strong foundation in cell culture, keen attention to detail, and enthusiasm for solving scientific challenges in a fast-paced, collaborative environment. Successful candidates will demonstrate competency in these areas and contribute to breakthrough developments in cell therapy. Key Responsibilities * Generate monoclonal cell lines and establish cell banks by transducing cells with viral vectors, expanding the cultures, isolating monoclonal populations through cell sorting, banking the validated cell lines, and performing functional qualification using lot-release potency and flow cytometry assays. Design and execute laboratory experiments to optimize DNA/RNA transfection, viral transduction, flow cytometry and plate based potency reporter gene assay parameters and procedures to meet the pre-defined analytical target profile. * Contribute to method qualification and transfer activities based on ICH/USP guidelines. * Analyze complex data sets, perform data trending and visualization, and maintain detailed experimental records in ELN for reproducibility and quality assurance. * Document cell line generation processes and experimental findings, contributing to SOPs, technical reports, and regulatory filings to ensure compliance and support innovation. * Cultivate and maintain cell lines and primary cells essential for innovative assay development. * Manage lab operations by overseeing inventories, scheduling equipment maintenance, and implementing process improvements for efficiency and productivity. Qualifications & Experience * Ph.D. in Immunology, Cell Biology, Bioengineering, or a related field with 0-3 years of industry experience; or an MS/BS with 5+ years of relevant laboratory experience. * Proficiency in cell culture, viral vector transduction, cell line engineering, flow cytometry, and relevant analytical assays (e.g., ELISA). * Experience with JMP and SoftmaxPro softwares is preferred. * Experience with vector construct design is highly desirable. * Background in DNA/RNA transfection, viral vector transduction, and potency release method development is preferred. * Strong organizational, documentation, and communication skills. * Ability to thrive in a collaborative, fast-paced, and dynamic environment. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Seattle - WA: $101,410 - $122,879 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $101.4k-122.9k yearly Auto-Apply 24d ago
  • Scientist II or III - Analytical Chemist Metrology Specialist

    Parexel 4.5company rating

    Olympia, WA jobs

    We are looking to fill a **Scientist II or III - Metrology Specialist** position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in **Rahway, NJ.** This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **This position does not offer sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $90k-121k yearly est. 36d ago
  • Scientist, Potency and Functional Characterization

    Bristol-Myers Squibb 4.6company rating

    Washington jobs

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary We are seeking a highly motivated professional to join the Cell Therapy Analytical Development team, specializing in cell line engineering and potency method development for viral vector applications. The ideal candidate will contribute to the optimization and qualification of cell-based viral vector transduction assays measured by flow cytometry and luminescent reporter genes. This position demands a strong foundation in cell culture, keen attention to detail, and enthusiasm for solving scientific challenges in a fast-paced, collaborative environment. Successful candidates will demonstrate competency in these areas and contribute to breakthrough developments in cell therapy. Key Responsibilities Generate monoclonal cell lines and establish cell banks by transducing cells with viral vectors, expanding the cultures, isolating monoclonal populations through cell sorting, banking the validated cell lines, and performing functional qualification using lot-release potency and flow cytometry assays. Design and execute laboratory experiments to optimize DNA/RNA transfection, viral transduction, flow cytometry and plate based potency reporter gene assay parameters and procedures to meet the pre-defined analytical target profile. Contribute to method qualification and transfer activities based on ICH/USP guidelines. Analyze complex data sets, perform data trending and visualization, and maintain detailed experimental records in ELN for reproducibility and quality assurance. Document cell line generation processes and experimental findings, contributing to SOPs, technical reports, and regulatory filings to ensure compliance and support innovation. Cultivate and maintain cell lines and primary cells essential for innovative assay development. Manage lab operations by overseeing inventories, scheduling equipment maintenance, and implementing process improvements for efficiency and productivity. Qualifications & Experience Ph.D. in Immunology, Cell Biology, Bioengineering, or a related field with 0-3 years of industry experience; or an MS/BS with 5+ years of relevant laboratory experience. Proficiency in cell culture, viral vector transduction, cell line engineering, flow cytometry, and relevant analytical assays (e.g., ELISA). Experience with JMP and SoftmaxPro softwares is preferred. Experience with vector construct design is highly desirable. Background in DNA/RNA transfection, viral vector transduction, and potency release method development is preferred. Strong organizational, documentation, and communication skills. Ability to thrive in a collaborative, fast-paced, and dynamic environment. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Seattle - WA: $101,410 - $122,879 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $101.4k-122.9k yearly Auto-Apply 25d ago

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