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7-10 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Scientist -Advanced Analytical Technology
Department: Advanced Analytical Technology
Location: Unit 3
Experience Required: 7-10 years
Educational Qualification: M.E/M.Tech/MS, M.Sc
Date Posted: 06-12-2023


Job Summary:

We are seeking a Senior Scientist for our Upstream Process Development team to design and execute media/feed screenings, optimizations, and process characterizations. The candidate will have extensive experience with bioreactor culture development, fed-batch, and N-stage perfusion technologies. Expertise in Design of Experiments (DOE) and scaling processes is essential for this role.


Key Responsibilities:

  1. Media/Feed Screenings & Optimizations:

    • Design and execute media/feed screenings and optimizations using ambr250 and bioreactor culture development, including fed-batch and perfusion cell culture processes.
  2. Scaling & Process Development:

    • Apply DOE expertise for scaling down and scaling up of upstream processes.
    • Develop bioreactor culture systems, including fed-batch and N-stage perfusion technologies (2 to 50L scale) using both glass and single-use cell culture technologies.
  3. Hands-On Experience:

    • Conduct process characterization studies and maintain proficiency in aseptic techniques, cell culture, and bioreactor operations.
    • Utilize small to medium-scale bioreactors, Cedex, Vi Cell, Osmometer, and other relevant equipment for process optimization.
  4. Cell Culture Handling:

    • Handle mammalian cell culture using bench-top, single-use bioreactors, and high-throughput systems such as ambr250, WAVE bioreactors, and ATF systems.
  5. Collaboration with MSAT Team:

    • Work closely with the MSAT team to maintain a scientific climate of excellence that aligns with business objectives.
    • Support process deviations, assess product impact, prepare technical reports, and suggest improvements.
  6. Data Analysis & Process Transfer:

    • Interact with development and manufacturing teams to analyze and map process data, identifying risks and opportunities for process improvements.
    • Assist in the transfer of scalable, efficient cell culture processes to clinical and commercial manufacturing facilities.
  7. Experimentation & Supervision:

    • Plan, assign, and supervise daily operations to ensure successful execution of experiments.
    • Review ongoing experimental data and oversee the review of functional PDR, TTD, etc.
  8. Automation & DOE Expertise:

    • Demonstrate practical expertise in process development, utilizing statistical design of experiments (DOE).
    • Experience with automation technologies is highly desired.
  9. Team Collaboration & Communication:

    • Collaborate effectively within cross-functional teams, including research, development, and manufacturing.
    • Display excellent communication and presentation skills with a strong problem-solving aptitude.

Skills & Qualifications:

  • Educational Qualification:

    • M.E/M.Tech/MS or M.Sc in a relevant field.
  • Experience:

    • 10-13 years of experience in upstream process development with a focus on cell culture and bioreactor technologies.
  • Core Skills:

    • Expertise in media/feed screenings, optimizations, and bioreactor culture development.
    • Strong DOE skills for process scaling, with experience in fed-batch and N-stage perfusion technologies.
    • Hands-on experience in process characterization and working with high-throughput systems like ambr250 and WAVE bioreactors.
  • Additional Skills:

    • Ability to collaborate in a dynamic, fast-paced team environment.
    • Strong interpersonal, communication, and presentation skills.
    • Knowledge of automation technologies in upstream process development