Current jobs related to Senior Analyst/Scientist, QC Chemistry - Woburn, Massachusetts - Tandym group


  • Woburn, Massachusetts, United States Vaxess Technologies Full time

    Job Title: Senior Research Associate/Associate Scientist, Analytical/QCVaxess Technologies is a pioneering company developing innovative vaccines and therapies based on its MIMIX platform. Our mission is to create products that are not only more effective but also more accessible to patients worldwide.We are seeking a highly motivated and collaborative...


  • Woburn, Massachusetts, United States ComforceHealth Full time

    Position Title: Lead Scientist, Quality Control ChemistryCompany: ComforceHealthPosition Overview:ComforceHealth is seeking a highly skilled Lead Scientist in Quality Control Chemistry to join our dynamic team. This role is essential for ensuring the integrity and reliability of our analytical testing processes.Key Responsibilities:Oversee and troubleshoot...


  • Woburn, Massachusetts, United States Ultragenyx Full time

    Job SummaryWe are seeking an experienced Analytical Chemistry Scientist to join our team at Ultragenyx. As a key member of our analytical development team, you will play a critical role in developing and qualifying advanced biophysical and analytical methods for AAV vectors.Key Responsibilities:Investigate and evaluate cutting-edge biophysical and analytical...


  • Woburn, Massachusetts, United States Pharmaron Full time

    Job OverviewPharmaron, a leading force in the life sciences industry, is seeking a highly skilled Senior Scientist I, Bioanalysis to join our Bioanalytical Laboratory team. In this pivotal role, you will lead the development and validation of new assays, including GxP assays, contributing significantly to the success of our laboratory operations.Key...


  • Woburn, Massachusetts, United States Innova Solutions Full time

    Job Title: Senior Quality Assurance SpecialistInnova Solutions is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our biopharmaceutical operations.Responsibilities:Collaborate with internal QC laboratories and...


  • Woburn, Massachusetts, United States Spear Bio Full time

    Position OverviewTitle: Senior Scientist/Scientist, Platform and Workflow DevelopmentCompany: Spear BioSpear Bio is an innovative and rapidly expanding start-up located in Woburn, Massachusetts, dedicated to revolutionizing the market with a cutting-edge ultrasensitive immunoassay platform that utilizes minimal sample volumes. Our primary focus is to support...


  • Woburn, Massachusetts, United States Spear Bio Full time

    Position OverviewTitle: Senior Scientist/Scientist, Platform and Workflow DevelopmentCompany: Spear BioSpear Bio is an innovative and rapidly expanding start-up located in Woburn, Massachusetts, dedicated to revolutionizing the field of ultrasensitive immunoassays with minimal sample requirements. Our primary goal is to enhance life sciences, clinical, and...


  • Woburn, Massachusetts, United States Spear Bio Full time

    Job Opportunity at Spear BioWe are seeking a highly skilled and experienced scientist to join our R&D team at Spear Bio, a rapidly growing start-up company focused on developing a novel ultrasensitive immunoassay platform.Key Responsibilities:Advance Platform Development: Lead the development of our technology by exploring and validating novel DNA-based...

  • Application Scientist

    2 weeks ago


    Woburn, Massachusetts, United States EHR Services Full time

    Job DescriptionEHR Services has partnered with Covaris, LLC to hire a highly skilled Application Scientist - Sample Prep to join their team in a dynamic and growing company.As an Application Scientist - Sample Prep within the Solutions Omics Group at Covaris, you will play a pivotal role in both internal development and external support of all Omics...


  • Woburn, Massachusetts, United States Jobot Full time

    Exciting Opportunity with a Thriving Organization in the Healthcare SectorThis position is hosted by Jobot. We are currently seeking a talented and experienced Senior Financial Analyst to join our dynamic team. The ideal candidate will play a crucial role in overseeing various financial operations with a strong emphasis on accrual accounting, ensuring that...


  • Woburn, Massachusetts, United States Boston Metal Full time

    Company OverviewBoston Metal is at the forefront of pioneering extractive metallurgy innovations aimed at transforming primary metals production. Our mission is to enhance metal quality while simultaneously reducing costs and minimizing environmental impact. We are seeking a Senior Electrochemical Scientist to become an integral part of our dynamic team.Key...


  • Woburn, Massachusetts, United States RTX Full time

    Position Overview:At RTX, we are dedicated to safeguarding our nation and allies through advanced technology and innovative solutions. We are currently seeking a Senior Cybersecurity Operations Analyst to join our esteemed Systems Management & Security (SMS) team.Key Responsibilities:As a Senior Cybersecurity Operations Analyst, your primary responsibilities...


  • Woburn, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryAs a Senior Associate, Quality Assurance, you will be responsible for performing QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. This role requires a strong understanding of cGMP/GLP and analytical instrumentation.Key...


  • Woburn, Massachusetts, United States Spear Bio Full time

    Position OverviewSalary: CompetitiveSpear Bio is an innovative and rapidly expanding startup located in Woburn, Massachusetts, dedicated to developing a groundbreaking ultrasensitive immunoassay platform that utilizes minimal sample volumes while ensuring exceptional data quality.As a Field Application Scientist, reporting directly to the Head of Platform...


  • Woburn, Massachusetts, United States Northern Bank Full time

    About the RoleAt Northern Bank, we are committed to fostering growth for individuals and small enterprises. We are currently seeking a Senior Treasury Analyst who recognizes the significance of operational and technical proficiency in ensuring our bank's continued success and in delivering outstanding products and services to our clients.Key...


  • Woburn, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryAs a Senior Associate, Quality Assurance, you will be responsible for performing QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. This role requires a strong understanding of cGMP/GLP and analytical instrumentation.Key...


  • Woburn, Massachusetts, United States STR Full time

    About the RoleThe SAAM Group within the Sensors Division at STR is seeking a Senior RF Analyst to lead high-performing multidisciplinary teams in developing and characterizing the impact of advanced concepts and algorithms on the performance and survivability of operational systems.Key ResponsibilitiesPerform system of system trades, modeling, simulation,...


  • Woburn, Massachusetts, United States American Tower Corporation Full time

    About the RoleWe are seeking a highly skilled Senior Reporting Analyst to join our Shared Services team at American Tower Corporation. As a key member of our team, you will play a critical role in developing and delivering standardized reporting that promotes overall business effectiveness and efficiency.Key ResponsibilitiesReporting and Analytics: Develop,...


  • Woburn, Massachusetts, United States Spear Bio Full time

    Job OpportunitySpear Bio is a rapidly growing biotechnology company based in the United States. We are seeking a highly skilled Field Application Scientist to join our team.Key ResponsibilitiesCommercialization and Sales Support: Drive the pre-sales process by presenting our technology and its applications to potential customers.Customer Success: Provide...


  • Woburn, Massachusetts, United States STR Full time

    About the RoleThe SAAM Group at STR is seeking a Senior RF Analyst to lead high-performing multidisciplinary teams developing and characterizing the impact of advanced concepts and algorithms on the performance and survivability of operational systems in various scenarios.Key ResponsibilitiesPerform system of system trades, modeling, simulation, and analysis...

Senior Analyst/Scientist, QC Chemistry

3 months ago


Woburn, Massachusetts, United States Tandym group Full time
Our client, a leader in the pharmaceutical industry, is seeking a Senior Analyst/Scientist, QC Chemistry to join their team.

This job is a fully onsite position - in Woburn, Massachusetts

W2 Only

The role involves performing environmental monitoring (EM) at a gene therapy manufacturing facility. Key responsibilities include sampling room and personnel EM, water for injection (WFI), clean steam, and compressed gases. The job also entails microbial enumeration, LIMS data entry, sample preparation, and assisting with technical issues. Additionally, the ideal candidate will review procedures, improve SOPs, and analyze EM results periodically. Flexibility in working hours and involvement in deviations, investigations, and CAPA actions may be required.

Responsibilities:


Execute analytical test methods to support the clinical development of new AAV pipeline candidates and release testing of commercial products.

Work with CROs for method development, validation, verification, and transfer, as needed.
Verify and pre-validate analytical test methods in preparation for method transfer to GMP CMO facilities, as needed.
Lead and supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
Support instrument lifecycle including, but not limited to, instrument on-boarding, validation, and troubleshooting/maintenance.

Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs) for internal use and transfer to external sites.

Performs peer review of both internal and externally generated data.
Lead and support QC deviations, investigations, CAPA, change control, analytical method performance trending and root cause analysis, as needed.

Investigate and evaluate cutting edge biophysical and analytical instrumentation and stay up to date on state-of-the-art methodologies for AAV characterization.

The job responsibilities may change as needed to support activities relevant to the clinical or commercial phase.

Qualifications:


BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.

Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is preferred.

HPLC/UPLC experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials by a variety of chromatographic methods (RP, SEC, IEX) is preferred.

Experience working with external contract labs (CMOs, CROs) is a plus.
Experience executing late-stage analytical comparability studies is preferred.
Strong collaboration and team-working skills.
Strong communication, interpersonal and organizational skills.

Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.

Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.

#J-18808-Ljbffr