Pharmanika is Hiring: Executive / Senior Executive – QC (Analytical & Biological Testing) in Genome Valley, Hyderabad, Telangana, India
The Bachwell Pharma QC job is for an Executive / Senior Executive – QC (Analytical & Biological Testing) specializing in Biologicals, Plasma-Derived Products, Hematology, and Immunotherapy Products in Genome Valley, Hyderabad, Telangana, India.
Job Details
Position: Executive / Senior Executive – QC (Analytical & Biological Testing)
Department: Quality Control, Physicochemical & Biochemical Testing, Immunological & Safety Testing, Method Validation, Transfer & Stability Studies, Instrument Management & Data Integrity
Experience: 1 – 4/5 – 7 years
Location: Genome Valley, Hyderabad, Telangana, India
Qualifications: M.Pharm / M.Tech (Microbiology/Biotechnology/Biochemistry)
Send your profile to: sreddy@bachwellpharma.com, bachwellpharma@gmail.com, hr@bachwellpharma.com
Bachwell Pharma QC Job Responsibilities
- Physicochemical & Biochemical Testing
- Protein Characterization & Content Analysis: Perform total protein quantification (Kjeldahl, Biuret, Bradford, BCA assays) and purity analysis for Human Albumin, Immunoglobulins (IVIG/SCIG), and plasma-derived coagulation factors.
- Chromatographic & Electrophoretic Assays: Execute High-Performance Liquid Chromatography (HPLC / UPLC – SEC, IEX, RP-HPLC) for aggregate detection, monomer purity, and charge variants. Perform SDS-PAGE, Capillary Electrophoresis (CE-SDS, cIEF), and agarose gel electrophoresis for structural integrity assessment.
- Potency & Biological Assays: Execute cell-based bioassays, enzyme activity assays, and binding assays (ELISA, Surface Plasmon Resonance) to evaluate biological activity and potency for immunotherapy candidates and specialized proteins.
- Hematology & Clotting Factor Assays: Perform specialized coagulation assays (e.g., Factor VIII, Factor IX, Thrombin Time, Fibrinogen content) using automated coagulometers and chromogenic substrate assays.
- Immunological & Safety Testing
- Immunochemical Testing: Conduct immunodiffusion, radial immunodiffusion (RID), nephelometry, and Western Blotting for specific protein quantification and residual impurity detection (e.g., host cell proteins [HCP], host cell DNA [HCD]).
- Viral Safety & Purity Assays: Support raw material screening and final batch release for plasma derivatives, ensuring compliance with viral inactivation and clearance verification testing protocols (BSL-2 / BSL-2+ safety standards).
- Physicochemical Properties: Measure pH, osmolality, thermal stability, heavy metals, residual moisture (Karl Fischer), and stabilizer concentrations (e.g., sodium caprylate, N-acetyltryptophan in Human Albumin).
- Method Validation, Transfer & Stability Studies
- Analytical Method Validation: For this Bachwell Pharma QC job, author protocols and execute method validation/qualification (ICH Q2(R1) / ICH Q6B) for analytical methods including HPLC, ELISA, CE, and bioassays across global market submissions.
- Instrument Management & Data Integrity
- Audit Readiness & SOP Authoring: A