Sales Development Assistant Manager- Biosimilar - Pune

The job involves relevant biosimilar experience from reputed biosimilar companies with experience of development of cell-based assays ELISA and experience working on flow cytometry-based assays preferable capable of designing experiment with minimal supervision and having experie ...

Job summaryProvide Quality Assurance support to US-based manufacturing and quality operations, ensuring compliance with global cGMP, ICH, and regulatory requirements with a strong focus on biosimilars. · Provide QA oversight and support to US-based manufacturing and quality opera ...

This role is responsible for executing upstream mammalian cell culture operations from vial revival to large-scale production as per cGMP. · ...

Regulatory Affairs Management- · Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. · Provides regula ...

Supervise overall · packing and visual inspection operations · in the Fill-Finish department. · Prepare and review documents including SOPs, BPRs, protocols, reports, and equipment qualification documents. · Ensure all equipment installed in the Fill-Finish packing area remains o ...

Perform method validation/verification activities and prepare documents for laboratory equipment and instruments. · ...

The job involves performing method validation/verification activities and preparing documents like specification, STPs, TDS, SOP, · COA etc. The candidate should have 10-12 years of relevant hands-on experience in tasks such as CEX-HPLC, · SE-HPLC etc. ...

Perform method validation/verification activities for drug substances (DS), drug products (DP), and in-process samples. · ...

Key Responsibilities: · Project planning, Gantt Preparation and timeline tracking. · Risk management: Identify project issues early on and facilitate resolution, work on risk mitigation plans and/or timely escalations · Managing across multiple workstreams to ensure dependencies ...

Project planning, Gantt Preparation and timeline tracking. · Risk management: Identify project issues early on and facilitate resolution, work on risk mitigation plans and/or timely escalations · Managing across multiple workstreams to ensure dependencies and milestone delivery. ...

Job Description-Regulatory Affairs Management- · Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. · ...

To perform method validation/verification activity (DS, DP, and in-process samples), stability, qualification of IRS and biosimilarity activity. · Preparation of documents like Specification, STPs, TDS, SOP, COA, MVP MVR MTR etc. · Coordination with vendor for external calibratio ...

Key Responsibilities: · Project planning, Gantt Preparation and timeline tracking. · Risk management: Identify project issues early on and facilitate resolution, work on risk mitigation plans and/or timely escalations · Managing across multiple workstreams to ensure dependencies ...

Key Responsibilities: · Project planning, Gantt Preparation and timeline tracking. · Risk management: Identify project issues early on and facilitate resolution, work on risk mitigation plans and/or timely escalations · Managing across multiple workstreams to ensure dependencies ...

Company Description · Enzene Biosciences Ltd., an integrated global CDMO, offers comprehensive services from discovery to commercial supply. The company utilizes its patented, fully-connected continuous manufacturing (FCCM) platform, EnzeneX, which is validated for commercial bio ...

Job Responsibilities: · Responsible for executing upstream mammalian cell culture operations from vial revival to large-scale production as per cGMP guidelines. · Operate and monitor single-use bioreactors for seed expansion and production batches. · Execute commercial, validatio ...

Job Description-Regulatory Affairs Management- · Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. · ...