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Deputy Manager/ Manager, Analytical method transfer
2 weeks ago
Job Title: Senior Biotechnology Analyst at XYZ Biopharmaceuticals
- Minimum degree required: M. Tech/M.SC in Biotechnology, Biology, Biochemistry, Chemical Engineering, or related field.
- Hands-on experience required: Minimum 12+ years' experience for M. Tech/M.SC level candidates (for B.S. candidates) in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
- Experience in analytical method development and validation studies for assays such as HPLC, GC, SDS-PAGE, Agarose gel electrophoresis, Densitometry, dd-PCR and RT-PCR, ELISA, UV-Visible Spectrophotometry, and Western-Blot, as well as microbiological techniques like BET - rapid release methods (Bac-T, PTS, MCS) and gel-clot, Bioburden and Sterility testing.
- Complete awareness of analytical method qualification and validation as per regulatory requirements.
- Understanding of method qualification criteria, handling of reference standards and reagents, routine calibration, and maintenance of laboratory instruments.
- Additional advantages include experience in new facilities and equipment commissioning and qualification.
- Familiarity with regulatory approvals of products at different stages and exposure to audits in regulated and emerging markets is compulsory.
- Proven track records of method validation with accuracy and highest standards of repeatability as per defined specifications.
- Familiarity with analyst qualification and understanding of cGMP, GLP, GDP, and data reliability.
- Technical proficiency required for successful validation and method transfer of analytical assays.
- Working knowledge of clone development, upstream fermentation, and downstream purification techniques.
- Relevant industry experience in GMP environment.
- Must possess self-motivation, organization, and proactivity.
- Strong knowledge of Environmental Monitoring (EM) requirements and tests, aseptic process validation, identifying microbial contaminants, and other applicable methods for biopharmaceutical testing.
- Training and experience to work safely around laboratory equipment, biohazardous substances, and hazardous chemicals in compliance with safety and quality standards.
- Working knowledge of quality systems and regulatory requirements.
- Technical aptitude including solving complex problems through scientific reasoning.
- Proficiency with software such as Lonza MODA, LIMS, TrackWise, and Documentum for microbiology functions.
- Strong knowledge of computer systems and software, including MS Word, Excel, PowerPoint, and Project, as well as statistical software and inventory systems.
- Ability to work flexible hours to support production and product transfer activities.
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