Biopharma

Job Title: Executive / Operator – Biologics (Downstream / QA / QC / Microbiology / RA)

Company: Ichor Biologics

Location: Shameerpet Medchal

Experience: 2 – 6 Years

Qualification: M.Sc / B.Sc / M.Pharm / B.Pharm / B.Tech

Open Positions: 30

Note: Immediate Joiners Preferred

Job Summary:

We are hiring experienced professionals for multiple roles in Biologics Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, and Microbiology. Candidates with hands-on experience in biologics/injectable manufacturing and QMS environments are encouraged to apply.

1️⃣ Downstream Process Executive / Operator

Key Responsibilities:

Perform Chromatography operations (RP, SEC, IEX)

Column Packing and TFF system handling

Execute downstream purification processes

Ensure compliance with QMS and GMP guidelines

Maintain batch documentation and process records

Required Skills:

Experience in Biologics / Injectable manufacturing

Knowledge of GMP & documentation practices

Hands-on experience in TFF & Chromatography systems

2️⃣ QA – IPQA (DS/DP – Biologics / Injectable)

Key Responsibilities:

Ensure line clearance before manufacturing activities

Conduct in-process checks during:

Component preparation

Aseptic filling

Sealing & packing operations

Review and maintain BMR & BPR in real-time

Monitor GMP compliance and documentation accuracy

Required Skills:

Experience in Injectable/Biologics QA

Strong understanding of GMP & regulatory compliance

3️⃣ QC – Biologics (Biopharma)

Key Responsibilities:

Perform HPLC / UPLC (RP, SEC, IEX)

Conduct SDS-PAGE, Western Blot, ELISA

Execute Cell-based potency assays

Maintain analytical documentation and reports

Ensure GLP compliance

Required Skills:

Experience in Biopharma analytical techniques

Strong laboratory documentation skills

4️⃣ DQA – Regulatory Affairs (Biologics)

Key Responsibilities:

Prepare and compile regulatory dossiers

Maintain CTD / eCTD / ACTD submissions (Modules 1–5)

Review regulatory documentation

Coordinate with internal departments for compliance

Required Skills:

Experience in Biologics regulatory submissions

Knowledge of international regulatory guidelines

5️⃣ Microbiology

Key Responsibilities:

Perform Bioburden testing

BET (Bacterial Endotoxin Testing)

Environmental Monitoring (EM)

MLT (Microbial Limit Testing)

Ensure compliance with GMP/GLP

Required Skills:

Experience in Injectable/Biologics microbiology testing