MS&T Specialist

5 days ago

Hyderabad Secunderabad Telangana, India beBeeMSaTspecialist Full time

Job Description

">

As a key member of our team, you will be responsible for leading Extractable and Leachable (E&L) risk assessments for materials based on supplier information. You will determine the risk level and update the Risk assessment accordingly. Your expertise in E&L studies, their methodologies, analytical strategies, and design will ensure that our products meet the highest standards of quality.

">
  • ">
  • Develop and maintain comprehensive material libraries backed by corresponding E&L test data.">
  • Coordinate Extractables studies or product-specific leachable studies, ensuring timely completion and effective collaboration with cross-functional teams.">
  • Prepare E&L Risk assessments, testing Protocols, and Reports, showcasing your attention to detail and analytical skills.">
  • Compile E&L data and provide it to Toxicologists for assessment, leveraging your proficiency in risk evaluation and decision-making.">
  • Utilize your knowledge of chemical and physical properties to understand the leaching tendency of MOC materials, making informed decisions to mitigate risks.">
  • Skilled in defining Original risk levels, Mitigation factors, and Final risk levels as part of the Risk Assessment process, ensuring accuracy and thoroughness.">
  • Expertise in setting AETs (Analytical Evaluation Thresholds) and SCTs (Safety concern thresholds) for extractables and leachables detected during testing.">
  • Detailed understanding of E&L guidelines, including SOPs, Pharmacopoeia, and ICH standards, enabling you to navigate complex regulatory environments effectively.">
  • Proficient in identifying and assessing the Worst-case material representative approach, ensuring compliance and minimizing risks.">
  • Collate material lists and data information from development centers and manufacturing sites, promoting seamless communication and collaboration.">
">

Required Skills and Qualifications

">

To succeed in this role, you should possess:

">
  • ">
  • Bachelor's degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams.">
  • Minimum 5 years of experience in MS&T or pharmaceutical manufacturing for small and large molecules.">
  • Proven project management experience in cross-functional environments, including multi-site and technical development settings.">
  • Excellent communication, presentation, and interpersonal skills, with proficiency in English (oral and written).">
  • Strong analytical and problem-solving skills, with attention to detail and ability to work under pressure.">
  • Knowledge of relevant regulatory guidelines and industry standards, including ICH Q7 and GMP.">
">

Benefits

">

We offer a dynamic and inclusive work environment, where you can grow professionally and personally. Our company values diversity and is committed to building an outstanding team representative of the patients and communities we serve.

">

Others

">

This is a unique opportunity to join a forward-thinking organization and contribute to the development of innovative solutions. If you are passionate about MS&T and committed to excellence, we encourage you to apply for this exciting role.

  • Ms&t expert

    2 weeks ago

    Hyderabad, Telangana, India BeBeeSpecialist Full time

    Job Title: Specialist - MS&T We are seeking a skilled and experienced professional to join our team as a Specialist in Manufacturing Science and Technology (MS&T). This role will be responsible for providing technical support to the manufacturing operations, ensuring compliance with regulatory requirements and optimizing processes to improve efficiency. Key...

  • Ms&t Expert

    3 weeks ago

    Hyderabad, Telangana, India BeBeeSpecialist Full time

    Job Title: Specialist - MS&T We are seeking a skilled and experienced professional to join our team as a Specialist in Manufacturing Science and Technology (MS&T).This role will be responsible for providing technical support to the manufacturing operations, ensuring compliance with regulatory requirements and optimizing processes to improve efficiency.Key...

  • MS&T Specialist Role

    2 days ago

    Hyderabad, Telangana, India beBeeExpertise Full time ₹ 75,00,000 - ₹ 1,50,00,000

    MS&T Specialist Role OverviewThe role of MS&T Specialist is crucial in ensuring seamless collaboration between Site MS&T teams and multifunctional technical operations teams within the Large molecules platform. This individual plays a key role in facilitating effective communication, supporting problem-solving activities, and driving process improvements.Key...

  • MS&T Expert

    2 weeks ago

    Hyderabad, Telangana, India beBeeSpecialist Full time

    Job Title: Specialist - MS&T We are seeking a skilled and experienced professional to join our team as a Specialist in Manufacturing Science and Technology (MS&T). This role will be responsible for providing technical support to the manufacturing operations, ensuring compliance with regulatory requirements and optimizing processes to improve efficiency. ...

  • Senior MS&T Specialist

    5 days ago

    Hyderabad, Telangana, India beBeeRiskAssessment Full time ₹ 1,80,00,000 - ₹ 2,20,00,000

    Job Title: MS&T SpecialistWe are seeking an experienced MS&T Specialist to join our team. The ideal candidate will possess expertise in Extractable and Leachable (E&L) risk assessment, including the ability to determine risk levels and update risk assessments.About the Role:The successful candidate will be responsible for building a comprehensive material...

  • Specialist - Ms&t

    3 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary The purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform.The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities.Maintain the oversight on Process and Validation...

  • Specialist - MS&T

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary The purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process and...

  • Specialist - MS&T

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description SummaryThe purpose of the Specialist role is to work collaboratively with Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process and Validation...

  • Specialist - MS&T

    4 weeks ago

    Hyderabad, Telangana, India myGwork Full time

    This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Summary The purpose of the Specialist role is to work collaboratively...

  • Specialist - MS&T

    5 days ago

    Hyderabad, Telangana, India Sandoz Full time

    Job DescriptionKey Responsibilities:Extractable and Leachable (E&L) Expertise- Understanding of Extractable and Leachable (E&L) risk assessment for materials based on supplier information and the ability to determine the risk level and update the Risk assessment.- Building a comprehensive material library backed by corresponding E&L test data- Managing the...