India's DMPLOI - Jobs & Networking AppAragen Biologics, a globally recognized contract research, development, and manufacturing organization (CRDMO), is inviting applications for the position of Senior Executive – Downstream Process Development within its Bioprocess R&D / Process Development division. This opportunity is ideal for experienced biotechnology professionals looking to contribute to advanced biologics development and manufacturing processes.
The company has been recognized as a Great Place to Work Certified Organization (2026–2027), reflecting its commitment to innovation, employee growth, and scientific excellence.
Position Overview
Details Information
Company
Aragen Biologics
Department
Bioprocess R&D / Process Development
Position
Senior Executive – Downstream Process Development
Qualification
M.Sc. / M.Tech. in Biotechnology, Biochemical Engineering, Biochemistry
Experience
4–6 Years
Job Location
Bangalore
Employment Type
Full-Time
Key Responsibilities
The selected candidate will play a crucial role in downstream process development for biologics manufacturing.
1. Downstream Process Development
Optimize Protein A capture processes.
Execute viral inactivation and polishing operations using AEX/CEX chromatography.
Perform ultrafiltration and diafiltration (UF/DF).
Conduct resin screening and column lifetime studies.
Monitor Critical Process Parameters (CPPs) to achieve Critical Quality Attributes (CQAs).
2. Scale-Up and Technology Transfer
Design and execute process characterization studies using Design of Experiments (DoE).
Support process robustness assessments.
Prepare and execute technology transfer protocols for GMP manufacturing.
Participate in Viral Clearance Studies (VCS).
3. Documentation and Regulatory Compliance
Maintain accurate laboratory notebooks and technical records.
Ensure compliance with ALCOA+ data integrity principles.
Author SOPs, technical reports, deviations, and supporting documentation.
4. Technical Expertise
Operate ÄKTA systems (Avant, Pure, Pilot) and Unicorn software.
Manage TFF/UFDF systems including cassette and hollow fiber filtration.
Apply ICH Q5A guidelines for viral safety and validation.
Utilize analytical techniques such as SEC, CEX, and quantitative Protein A assays.
Desired Candidate Profile
Aragen is looking for professionals who possess:
Strong understanding of downstream biologics processing.
Hands-on experience with chromatography and filtration technologies.
Knowledge of GMP and regulatory expectations.
Experience in process scale-up and technology transfer.
Excellent documentation and technical writing skills.
Ability to work collaboratively in multidisciplinary teams.
Why Join Aragen Biologics?
Opportunity to work on cutting-edge biologics development projects.
Exposure to advanced purification and process development technologies.
Collaborative scientific environment.
Career growth within a globally recognized CRDMO.
Certified Great Place to Work organization.
How to Apply
Interested candidates meeting the eligibility criteria can share their updated resume to:
Email: Prashanth.Cherugad@aragen.com
Applicants are advised to mention “Senior Executive – Downstream Process Development” in the subject line of the email.
Technical FAQs
1. What is the purpose of Protein A chromatography in downstream processing?
Protein A chromatography is primarily used for monoclonal antibody purification. It selectively binds antibodies, enabling high-purity product recovery during the capture step.
2. What is the difference between AEX and CEX chromatography?
AEX (Anion Exchange Chromatography): Binds negatively charged molecules.
CEX (Cation Exchange Chromatography): Binds positively charged molecules. Both are commonly used for polishing and impurity removal during biologics purification.
3. Why is UF/DF important in biologics manufacturing?
Ultrafiltration/Diafiltration (UF/DF) is used to concentrate proteins and exchange buffer systems, ensuring the final product meets formulation requirements and quality standards.
4. What are Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)?
CPPs are process variables that can impact product quality, while CQAs are measurable product characteristics that must remain within predefined limits to ensure safety and efficacy.
5. What is the significance of ICH Q5A guidelines?
ICH Q5A provides regulatory guidance for evaluating viral safety in biotechnology products derived from cell lines of human or animal origin, ensuring product safety and regulatory compliance.
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