Associate- Drug Substance Downstream

Biocon; Johor Bahru; On-site; MYR 70,000 - 100,000; Full time

Job summary

Biocon Biologics in Malaysia seeks a production specialist to support GMP-compliant manufacturing, ensuring strict adherence to operation instructions. You will update real-time DSP data (BMRs/CKL/LS/ECC) and execute qualification and validation protocols for equipment.

Ideal candidates bring a chemical engineering background, strong problem-solving skills, and good teamwork abilities to maintain seamless downstream operations in a global biosimilars setting.

Qualifications

• Bachelor in Chemical engineering or related field.
• Strong communication and teamwork skills.
• Good problem-solving and decision-making abilities.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production operation instructions are strictly followed.
• Update real time data entry in DSP related documents.
• Execute equipment qualification and validation protocols.
• Knowledgeable in GMP, GDP and DI systems.
• Perform and document operations in accordance with cGMP.
• Coordinate with maintenance for production equipment upkeep.
• Comply with EHS policies and procedures.
• Ensure OTIF execution for downstream activities.

Skills

Communication

Teamwork

Problem solving

Education

Bachelor in Chemical engineering or related

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 monitor the compliance with the requirements of Good Manufacturing Practice
• To ensure the instructions relating to production operations are strictly followed
• To update the real time data entry in BMR’S,CKL ,LS ,ECC and other documents in DSP
• To execute equipment qualification protocols and validation protocols
• Knowledgeable in GMP system, GDP and DI.
• To perform and document operations in accordance with cGMP
• Maintenance of Production equipment in co-ordination with maintenance department
• To comply with EHS policies and procedures
• Responsible for OTIF execution of all the activities related to Downstream

Required Skills & Competencies

• Bachelor in Chemical engineering or related
• Good in soft skill such as communication and team work.
• Good in Problem solving and decision making