Junior Associate , Associate , Assistant Manager - Drug Substance Upstream MFG

Biocon Biologics; Johor Bahru; On-site; MYR 60,000 - 120,000; Full time

Job summary

Biocon Biologics, a biopharmaceutical subsidiary, seeks a candidate with 1–10 years in biopharma upstream operations and a strong foundation in biotechnology or related fields. The role emphasizes cGMP, GDP, GLP and data integrity training, with duties centered on documentation quality and ALCOA compliance.

Training is annual and mandatory to ensure GxP adherence. Candidates should have a Bachelor’s or Diploma in Biotechnology or related disciplines and be prepared to work within a GxP

Qualifications

• Bachelor’s degree or diploma in biotechnology or related field.
• 1-10 years of hands-on experience in biopharma or pharmaceutical upstream/related operations.
• Experience with cGMP, GDP, GLP, DI and data integrity standards is preferred.

Responsibilities

• Gain knowledge on cGMP, GDP and GxP training relevant to the role.
• Undergo mandatory annual cGMP training.
• Provide information, guidance, and recommendations to facilitate DI and GDP documentation.
• Ensure documentation is accurate, legible, complete and ALCOA compliant.
• Support compliance with GxP environments.

Education

Bachelor’s Degree in Biotechnology

Biochemical and Chemical Engineering

Industrial Biotechnology

Diploma in Biotechnology

Diploma in Chemical

Job description

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Roles and Responsibilities

• To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
• Employee who are involved in GMP activities should undergo mandatory cGMP Training.
• Frequency of mandatory training is once in a year.
• All employees that involving with GxP environment should undergo a mandatory basic microbiology training.
• To provides information guidance and recommendations to facilitate compliance with DI, GDP in documentation.
• To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
• Bachelor’s Degree in Biotechnology, Biochemical and Chemical Engineering, Industrial Biotechnology or Diploma in Biotechnology ,Chemical or equivalent field.
• 1- 10 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance Upstream manufacturing or related process operations