Development Associate/Sr. - Jr. Development Assistant (Virologist)

Zelle Biotechnology; Mumbai; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Zelle Biotechnology seeks a Development Associate/Senior-Jr. Development Assistant to contribute to viral clearance and purification process development at our Mumbai facility.

You will work under GLP guidelines, perform diverse analyses, review data, and validate new analytical methods while adhering to SOPs and ensuring approvals are on record.

Qualifikationen

• Masters in Life Sciences or related field.
• 3+ years in viral clearance or purification process development, incl. 1+ year in related work.
• 2+ years lab experience under GLP guidelines.
• Knowledge of Viral Clearance and GLP guidelines (ICH Q5A, OECD).
• Detail oriented with strong organizational skills.
• Effective written and oral communication skills.
• Professionalism and confidentiality.

Aufgaben

• Report to the lead in Viral clearance.
• Ensure GLP guidelines are followed.
• Perform analyses in molecular, cell biology, and virology areas.
• Review and evaluate raw data for acceptability.
• Set up and validate new analytical processes.
• Follow SOPs and ensure study plan approvals are documented.

Kenntnisse

GLP compliance

Molecular biology

Cell biology

Virology

Data review

SOP adherence

Analytical skills

Communication

Ausbildung

Masters in Life Sciences

Tools

Plaque assays

Virus production

Jobbeschreibung

Role Overview:

The Development Associate/ Sr. - Jr. Development Assistant will be responsible viral clearance or purification process development

Key Responsibilities:

• Report to the lead in Viral clearance


• Ensure that GLP guidelines are followed


• Perform a wide range of analyses (routine and non-routine) primarily but not limited to the molecular, cell biology, and virology test areas of Biopharmaceutical Services, cell culturing, plaque assays, and virus production.


• Review and evaluate raw data for acceptability


• Set up and validate new analytical or related processes used by the department.


• Follow appropriate and technically valid Standard Operating Procedures (SOPs).


• Ensure documented approval of the study plan and amendment(s) by the Study Director and ensure that the approved study plan and amendment(s) are made available to the quality assurance personnel by the Study Director

Key Competencies:

• Masters in a Life Sciences discipline or other relevant area.


• 3+ years of relevant experience including a minimum of 1+ year of related work experience in viral clearance or purification process development


• 2+ years of experience working in a lab environment under GLP guidelines


• Knowledgeable in appropriate Viral Clearance and GLP guidelines (including ICH Q5A and OECD Guidance etc.).


• Must be detailed oriented and have excellent organizational skills.


• Must possess effective written and oral communication skills.


• Must display a high degree of professionalism and confidentiality.