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Saturday, November 2, 2024
Hetero biopharma hiring M.Tech /B.Tech/ M.Sc Biotechnology/Biochemistry/Any life sciences for Analytical development lab (R&D)
Company: Hetero biopharma
Department: Analytical development lab (R&D)
Experience: 2-4yrs
Preferable: Biologics/Injectables
Job Location: Hetero Biopharma ltd, Jadcherla, Telanagana.
Job Responsibilities:
- Development of Mass spectrometry-based methods for analysis of various molecules, LC-MS data generation for pivotal studies such as bio similarity, comparative studies etc.
- Operation and maintenance of Mass spectrometry instrument and ancillary units. Routine monitoring of the instrument performance and assist in any troubleshooting activities.
- Developing and carrying out multiple assays aimed at characterization of protein-based therapeutics across various stage of the projects.
- Participate in the design, development, and implementation of methods for critical quality attribute characterization of the molecule. Interpret results and draw conclusions from multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
- Follow procedures and protocols, maintain accurate records, lab notebook and generate quality data fir product development and analytical studies.
- Collection and organization of technical data, author documents such as SOP, MOA and reports necessary for product development and analytical studies.
Note: Please mention mail subject as "Application for Analytical development"
Kemwell Biopharma Pvt. Ltd hiring for Process Development department Scientist/Sr. Scientist MSAT, USP || Apply now
Exciting Opportunity at Kemwell Biopharma Pvt. Ltd.!
We are urgently looking for Scientist/Sr. Scientist MSAT, USP
Company: Kemwell Biopharma Pvt. Ltd
Job role: Scientist/Sr. Scientist MSAT, USP
Department: Process Development (PD)
Experience Level: 8 - 12 Years
Job Location: Bangalore
Responsibility brief:
We are looking for Scientist/Sr. Scientist with 8-12 years of experience in MSAT for Upstream Process. The candidate will report directly to Head – PD & MSAT, and will be responsible for delivering all upstream related activities in MSAT for current commercial projects as well as ongoing clinical Phase I/III projects. The candidate is expected to have good documentation skills as the role involves leading investigations for technical issues/deviations in Manufacturing. A good understanding of QMS procedures is preferred. Candidate must have proven competency in technical, inter-personal skills and communication skills.
Key Responsibilities:
1. Lead upstream technology transfer from PD to Manufacturing.
2. Prepare documents including but not limited to upstream scale-up strategy, process validation, general study protocols for performing studies in Manufacturing and scale-comparability reports.
3. Review documents including but not limited to technology transfer documents prepared by PD, batch records, solution preparation records, campaign protocols and reports.
4. Provide shop-floor support during Manufacturing campaigns.
5. Lead/assist in investigations pertaining to deviations in manufacturing and ensure timely closure of the deviation reports.
6. Collaborate with PD team to perform small-scale experiments to understand scale-up challenges, for example, satellite batches.
7. Compile data from manufacturing campaigns and perform periodic data review.
8. Perform continuous process verification for manufacturing batches of existing commercial products.
9. Evaluation and implementation of PAT initiatives.
10. Communicate updates to client during manufacturing campaigns as needed.
11. Ensure compliance to Quality Assurance systems.
Qualification:
Education and Experience: BTech/MSc/MTech in Chemical Engineering/Biotechnology/Biochemistry/Life Sciences. Candidate should have 8-12 years relevant experience in Upstream activities in Process Development/MSAT.
If you are passionate about cutting-edge biotechnology and want to be part of a dynamic team driving innovation, apply now!
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