QC Lead, Chemistry

2 days ago

College Station, Texas, United States FUJIFILM Corporation Full time
Job Title: Quality Control Chemist Lead

At FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled and experienced Quality Control Chemist Lead to join our team. As a key member of our Quality Control department, you will be responsible for mentoring and leading a team of chemists in performing in-process, release, and stability testing using established analytical methods.

Key Responsibilities:
  • Lead QC analytical testing for GMP in-process, release, and stability testing as needed.
  • Conduct PH Conductivity & qPCR, HPLC, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide Mapping, DNA Sequencing, and/or UV/Vis Spectrometry.
  • Residual Analysis and/or Surfactant Analysis, Osmolality testing, Western Blot, and executes technical transfer, qualification, and validation protocols as needed.
  • Leads evaluation of equipment for use, IQOQ evaluation, and helps maintain safety and orderliness of the lab, applying knowledge of cGMPs and GLPs on a daily basis.
  • Technical Writing: writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate, qualification protocols, transfer protocols, creating manuals for processes/activities, sample plans (support & edit), and leads the initiation and closure of deviations, CAPAs, and Change Controls.
  • Reviews data obtained for compliance to specifications and reports excursion/out of specifications, leads OOS investigations and support as needed, and leads QC support for the sites Environmental Monitoring program and raw material analysis.
  • Ensures lab is maintained (organized, clean, properly supplied) and performs other duties as assigned.
Requirements:
  • Bachelor's degree in Chemistry or Biochemistry with 4+ years of hands-on laboratory experience or Associate's degree in Chemistry or Biochemistry with 6+ years of hands-on laboratory experience.
  • 4+ years' industry experience in a GMP/GxP or a comparable federally regulated environment required.
  • Familiar with monoclonal antibody testing methodology, experience in assay troubleshooting and problem-solving, ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end, and explain process.
  • Excellent communication skills, ability to work independently or in a team, perform as a SME in the designated methods transferred into FDBT, previous pipetting experience, ability to follow safety procedures outlined in the Chemical Hygiene Plan, utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
  • Excellent attention to detail, computer proficiency, excellent written and oral communication skills, excellent organization and analytical skills, and role model for company core values of trust, delighting our customers, Gemba, and Genki.
Physical Requirements:
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Experience prolonged standing, some bending, stooping, and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Ability to sit for long periods to work on a computer.
  • Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
  • Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
  • Ability to lift up to 30 pounds on occasion.

  • QC Lead, Chemistry

    2 days ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Quality Control Lead, ChemistryAt FUJIFILM Holdings America Corporation, we are seeking a highly skilled Quality Control Lead, Chemistry to join our team. As a key member of our Quality Control department, you will be responsible for mentoring and guiding a team of chemists in performing in-process, release, and stability testing using established...

  • QC Manager Quality Control Specialist

    1 week ago

    College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Job Title: QC Manager Quality Control SpecialistFujifilm Diosynth Biotechnologies is seeking a highly skilled QC Manager Quality Control Specialist to join our team in College Station, TX.Job Summary:The QC Manager Quality Control Specialist will be responsible for overseeing all activities involved with Drug Product Quality Operations, including Aseptic...

  • QC Manager Quality Control Technician

    2 weeks ago

    College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Job Title: QC Manager Quality Control TechnicianFujifilm Diosynth Biotechnologies is seeking a highly skilled QC Manager to join our team in College Station, TX. As a key member of our Drug Product Operations team, you will be responsible for overseeing all activities involved with Drug Product Quality Operations.Key Responsibilities:Oversee all activities...

  • Quality Control Supervisor

    3 weeks ago

    College Station, Texas, United States Astrix Full time

    Job Title: Quality Control SupervisorAstrix is seeking a highly skilled Quality Control Supervisor to join our Chemistry department. As a key member of our team, you will be responsible for overseeing the daily activities of our QC Chemistry staff, ensuring the smooth operation of our analytical equipment, and maintaining the highest standards of quality and...

  • Chemist II

    4 weeks ago

    College Station, Texas, United States Fujifilm Holdings Corp Full time

    Job Summary:Fujifilm Holdings Corp is seeking a highly skilled Chemist II to join our team in a key role that involves performing QC analytical testing for GMP release and stability testing as needed. The ideal candidate will have a strong background in analytical chemistry and experience with various laboratory techniques.Key Responsibilities:Perform QC...

  • Chemist II

    4 weeks ago

    College Station, Texas, United States Fujifilm Holdings Corp Full time

    Job Summary:Fujifilm Holdings Corp is seeking a highly skilled Chemist II to join our team in a key role that involves performing QC analytical testing for GMP release and stability testing as needed. The ideal candidate will have a strong background in analytical chemistry and experience with various laboratory techniques.Key Responsibilities:Perform QC...

  • Analytical Tech Associate Director

    5 days ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Associate Director of Quality Control Analytical TechJob Summary:The Associate Director of Quality Control Analytical Tech is responsible for directing and overseeing analytical development activities and method transfer activities in support of process development and manufacturing. This includes raw materials, in-process testing, drug substance...

  • Manufacturing Lead

    4 weeks ago

    College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    About the RoleThe Manufacturing Lead will play a crucial role in the production process at Fujifilm Diosynth Biotechnologies. This position will be responsible for overseeing the manufacturing of various biotechnology products, ensuring that all processes are carried out in accordance with good manufacturing practices (GMP) and regulatory requirements.Key...

  • Senior Manager, Quality Control Microbiology Lead

    2 weeks ago

    College Station, Texas, United States Matica Biotechnology, Inc. Full time

    Job Title: Senior Manager, Quality Control MicrobiologyMatica Biotechnology, Inc. is a leading biopharmaceutical research and development company that is at the forefront of innovation. We are seeking a highly skilled and experienced Senior Manager, Quality Control Microbiology to join our team.Job Summary:The Senior Manager, Quality Control Microbiology...

  • Solution Preparation Unit Lead

    1 month ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    About the RoleFUJIFILM Holdings America Corporation is seeking a highly skilled Manufacturing Operations Supervisor to join our team. As a key member of our manufacturing operations team, you will be responsible for overseeing the daily activities of our Solution Preparation Unit, ensuring the highest quality standards are met, and driving process...

  • Manufacturing Supervisor, Solution Preparation Unit Lead

    3 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Manufacturing Supervisor, Solution PrepOverview:FUJIFILM Corporation is seeking a highly skilled Manufacturing Supervisor to join our team in College Station, TX. As a key member of our manufacturing department, you will be responsible for supervising daily manufacturing activities and staff, ensuring the highest quality products are produced...

  • Quality Assurance Supervisor

    2 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Quality Assurance SupervisorWe are seeking a highly skilled Quality Assurance Supervisor to join our team at FUJIFILM Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the overall performance of our QA group and handling all associated responsibilities in compliance with Fujifilm quality...

  • Manufacturing Supervisor

    5 days ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Manufacturing Supervisor - Downstream OperationsFujifilm Corporation is seeking a highly skilled Manufacturing Supervisor to join our team in College Station, Texas. As a key member of our manufacturing team, you will be responsible for supervising daily manufacturing activities and staff, ensuring the quality and safety of our products.Key...

  • Quality Assurance Specialist II

    3 days ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Quality Assurance Specialist IIAt FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled Quality Assurance Specialist II to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our pharmaceutical and biotechnology products.Key Responsibilities:Review...

  • Program Director

    4 weeks ago

    College Station, Texas, United States Fujifilm Corporation Full time

    Job DescriptionJob Title: Program DirectorJob Summary:Fujifilm Diosynth Biotechnologies (FDB) is seeking a highly skilled and experienced Program Director to join our team. As a Program Director, you will be responsible for the planning and delivery of programs from contract signature to program closure, ensuring that the organization provides services in...

  • Senior Manager, Quality Control Microbiology Specialist

    6 days ago

    College Station, Texas, United States Matica Biotechnology, Inc. Full time

    Job Title: Senior Manager, Quality Control MicrobiologyMatica Biotechnology, Inc. is a leading biopharmaceutical research and development company that is at the forefront of innovation. We are seeking a highly experienced and skilled Senior Manager, Quality Control Microbiology to join our team.Job Summary:The Senior Manager, Quality Control Microbiology...

  • Manufacturing Supervisor

    1 week ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Supervisor to join our team at FUJIFILM Corporation. As a key member of our manufacturing operations, you will be responsible for supervising daily activities and staff, ensuring the implementation of project safety and quality assurance programs, and executing SAP functionality for batch close out and...

  • Manufacturing Supervisor

    6 days ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Manufacturing SupervisorOverviewFujifilm Holdings America Corporation is seeking a highly skilled Manufacturing Supervisor to join our team. As a key member of our manufacturing operations, you will be responsible for supervising daily activities and staff, ensuring the highest quality products are produced while maintaining a safe and efficient...

  • Head of Process Development

    3 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    About the RoleFujifilm Corporation is seeking a highly skilled and experienced professional to lead our Process Development team. As the Head of Process Development, you will be responsible for providing strategic leadership and direction to the team, ensuring the successful development and implementation of new processes and technologies.Key...

  • Manufacturing Supervisor

    6 days ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Supervisor to join our team at FUJIFILM Holdings America Corporation. As a key member of our manufacturing team, you will be responsible for supervising daily manufacturing activities and staff, ensuring the quality and safety of our products, and implementing project safety and quality assurance...