Procell Biologics Private Limited has announced exciting career opportunities for experienced professionals in R&D Analytical and Formulation R&D. The company is looking for candidates with expertise in biologics, biosimilars, analytical method development, formulation development, and GMP/ICH guidelines. Eligible candidates can send their updated CV via email.

About Procell Biologics

Procell Biologics Private Limited is a biotechnology company specializing in biologics and biosimilar product development. The organization focuses on advanced research, analytical characterization, formulation development, and regulatory-compliant manufacturing practices.

Job Overview

Particulars Details

Company Name

Procell Biologics Private Limited

Job Type

Full-Time

Job Location

Genome Valley, Turkapally, Shamirpet, Hyderabad, Telangana – 500078

Industry

Biotechnology / Biopharmaceutical

Application Mode

Email

Official Website

www.procellbiologics.com

Available Positions

1. R&D Analytical

Experience: 8–10 Years

Qualification: M.Sc. in Analytical Chemistry, Biotechnology, Biochemistry, or Life Sciences

Required Skills:

HPLC/UPLC analysis

Method development for therapeutic proteins

Biosimilarity assessment

Analytical method validation

Physicochemical characterization

Stability studies

Knowledge of GMP and ICH guidelines

2. Formulation R&D

Experience: 3–6 Years

Qualification: M.Sc. / M.Pharm. / M.Tech. in Biotechnology, Pharmacy, or Life Sciences

Required Skills:

Formulation development of biologics and biosimilars

Buffer optimization

Stability studies

Excipient selection

3. Senior Formulation R&D

Experience: 8–10 Years

Qualification: M.Sc. / M.Pharm. / M.Tech. in Biotechnology, Pharmacy, or Life Sciences

Required Skills:

Formulation development of monoclonal antibodies

Insulin analogue formulation

Lyophilization

Process scale-up

Regulatory-compliant documentation

Educational Qualification

Candidates should possess one of the following:

M.Sc. (Analytical Chemistry/Biotechnology/Biochemistry/Life Sciences)

M.Pharm.

M.Tech. in Biotechnology

Other relevant Life Science qualifications as specified

Experience Required

3–6 years for Formulation R&D

8–10 years for R&D Analytical

8–10 years for Senior Formulation R&D

Key Technical Competencies

HPLC and UPLC operation

Analytical method development and validation

Biosimilarity assessment

Biologics formulation development

Monoclonal antibody formulation

Insulin analogue formulation

Buffer optimization

Excipient compatibility studies

Lyophilization process

Stability studies

GMP and ICH compliance

Regulatory documentation

Job Location

Procell Biologics Private Limited

Building #189, Synergy Square 1, MN Park, Genome Valley, Turkapally, Shamirpet, Hyderabad, Telangana – 500078

How to Apply

Interested and eligible candidates should send their updated CV to:

Email: farheen.k@procellbiologics.com

Why Join Procell Biologics?

Opportunity to work on advanced biologics and biosimilars

Exposure to cutting-edge analytical technologies

Research-driven work environment

Career growth in biotechnology and biopharmaceutical R&D

Experience with global quality and regulatory standards

Technical FAQs

1. What analytical instruments are expected for the R&D Analytical role?

Candidates should have hands-on experience with HPLC, UPLC, analytical method development, validation, and characterization techniques used for therapeutic proteins.

2. What is biosimilarity assessment?

Biosimilarity assessment is the comparison of a biosimilar product with its reference biologic using analytical, functional, and stability studies to demonstrate comparable quality, safety, and efficacy.

3. Why is lyophilization important in biologics formulation?

Lyophilization (freeze-drying) improves the stability and shelf life of sensitive biologic products by removing water under controlled conditions while maintaining product integrity.

4. What are GMP and ICH guidelines?

GMP (Good Manufacturing Practices) ensures consistent product quality and safety, while ICH (International Council for Harmonisation) provides internationally accepted guidelines for pharmaceutical quality, safety, efficacy, and regulatory compliance.

5. What is involved in formulation development of biologics?

Formulation development includes selecting suitable buffers and excipients, optimizing pH, evaluating stability, conducting compatibility studies, process scale-up, and preparing regulatory-compliant documentation to ensure product quality and performance.