Analytical R&D (Biologics) For Bio Pharma R&D
- BVR People
- 5 to 10 Yrs
- Bengaluru
- 2 years ago
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Job Description
Roles and Responsibilities
Job Title: Analytical R&D (Biologics)
Company: Leading Pharma (Biologics R&D) Company in Bangalore Location
Designation: Senior Executive to Deputy Manager
Reporting to: Manager
No. of Positions: 5
Division: Biologics
Department: R&D (Biologics)
Job Location: Bangalore
Qualification: M.Pharma/M. Tech/M. Sc/B. Tech Chemical Engg/Biotechnology/Biochemistry
Years of Experience: 5 to 12 Years
Salary Range: 5 to 15 LPA
Contact person: Mr.Zabi Moghal
Mobile: 8105301***
Email: za*i@bv**c.com
Key Responsibilities (1):
1. The position is for an experienced individual in formulation and analytical development.
2. Should have sound knowledge and experience in developing formulations for novels/ biosimilar products.
3. Experience in designing experiments for pre formulation and formulation screening is required.
4. Hands on experience in performing analytical techniques is a must ex, SEC HPLC, RP HPLC etc
5. Experience in developing liquid, lyo and PFS formulation is desirable. Hands on experience in lyo development is desirable.
6. Preparing protocols for stability studies and executing the stability study is mandatory.
7. The candidate should have good writing and presentation skills.
8. Experience in technology transfer is a plus.
9. Ensure compliance to Quality Assurance systems.
Key Responsibilities (2):
1. Performing Method Development, Qualification, Verification, Transfer activities under supervision.
2. Execution of experiments related to method development, characterization studies.
3. Preparing documents related to Quality management such as change control, deviation management.
4. Preparing SOPs, Analytical Test Procedure, and technical documents.
5. Knowledge of Analytical instruments such as Capillary electrophoresis, HPLC, UPLC, UV-Spectrophotometer, and also various chromatographic techniques such as SEC, IEX, RP, HIC, Peptide mapping, Glycan, etc.
6. Knowledge and hands-on experience on the plate-based ELISA method is plus.
7. Theoretical knowledge and hands-on experience in analytical method development and characterization, data compilation, and interpretation of various analytical methods including chromatographic and electrophoretic methods.
Key Responsibilities (3):
1. Developing analytical methods for bio pharmaceuticals including various types of antibodies as well novel biologics.
2. Supervising the analytical development activities particularly physicochemical and functional assays for antibodies/novel biologics.
3. Designing experiments and plan activities with analytical strategies and execute the same within timelines.
4. Collaborating with cross-functional departments for routine day-to-day activities to resolve the issue/problem with proper time management.
5. Reviewing lab notebooks, data recording sheets, analytical results, stability data, and ensure timely release of analytical results/reports.
6. Implementing and review department standard operating procedures (SOPs), Analytical test procedures, and other procedures as per the quality policy.
7. Qualification and maintenance of reference standards.
8. Ensuring the established Standard Operating Procedures, industry practice, and regulatory guidance as appropriate
9. Conducts a second analyst review of analytical data and monitor the ongoing activities.
10. Prepare protocols and reports for method development, qualification, and transfer.
11. Ensure calibration of laboratory instrument/equipment as per the schedule.
12. Control of reference medicinal products, routine samples, laboratory chemicals/kits, required for analytical development activities.
13. Train team members on the advances in analytical method development and other updates.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Analytical R&D (Biologics) For Bio Pharma R&D
Contact Details:
Company: BVR People ConsultingLocation(s): Bengaluru
Keyskills: analytical method development standard operating procedures music making change control data recording test procedures quality assurance stability studies quality management method development technology transfer uv spectrophotometer analytical techniques analytical instruments capillary electrophoresis chromatographic techniques analytical development rp iex sec
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