Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma’s global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities.Â
- Vacancy details:
- Department: Executive/Sr. executive- Protein Characterization
- Experience: 2 to 6 years of relevant industrial experience
- Qualification: M.SC./M.Tech in Biochemistry / Life Sciences / Biotechnology.
- Salary:₹ Not Disclosed
Job Description: Greeting from Sun Pharma Pvt Ltd!!!
Important Details :
- Location: Tandalja – R&D
- Post of date :21/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
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Job Objective
Searching for highly motivated candidate having technical expertise in Biosimilar product characterization.
Key Responsibilities:Â
The candidate is expected to develop LC-MS based methods for protein and peptide product characterization.
The candidate is expected to qualify the methods for intended purpose for all pipeline products.
The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile.
Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc.
Preparation and review of method development reports (MDR) and analytical test procedures (ATP).
Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations.
The candidate is responsible for the operation and maintenance of the MS instruments
To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues.
Responsible for managing the regulatory queries.
The candidate is expected to draft the technical content for regulatory dossier.
Educational Qualification:Â
- M.SC./M.Tech in Biochemistry / Life Sciences / Biotechnology.
Technical/functional Skills:
- Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins.
- Experience of biosimilarity assessment of biologics for regulated market is desirable.
- Experience of analytical development for monoclonal antibodies and fusion proteins and peptide is highly desirable.
Experience:
- 2 to 6 years of relevant industrial experience
Behavioral Skills:
- Highest emphasis on Ethics and Data Integrity
- Commitment to maintaining Safe work practices and Safety compliant Behaviour at workplace
- Commitment to Quality, Compliance, Efficiency, Cost, On-Time Delivery
- Effective Communications skills (verbal and written) is desirable.
- Proactive nature with excellent interpersonal skills to build and maintain professional working relations
- Ability to handle cross-functional requirements.
- Work collaboratively with other team members in an effective and cordial manner
