Associate - Drug Substance Manufacturing

Biocon Biologics; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

Biocon Biologics, a global biopharmaceutical leader, seeks a Chemical Engineer to support downstream manufacturing. You will ensure GMP compliance, follow production instructions, and maintain equipment in a fast-paced biosubstance production environment.

The ideal candidate has a Bachelor's in Chemical Engineering with 1–3 years of hands-on pharma experience and strong communication and teamwork skills. On-site role based in Malaysia's Johor region.

Qualifications

• Bachelor’s degree in Chemical Engineering is mandatory.
• 1–3 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Strong communication and teamwork skills.
• Good problem solving and decision making.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production operation instructions are strictly followed.
• Update real-time data entry in Batch Manufacturing Records and related documents.
• Execute equipment qualification and validation protocols.
• Perform operations in accordance with cGMP.
• Maintain and calibrate production equipment in coordination with maintenance.
• Comply with EHS policies and procedures.
• Ensure OTIF execution for Downstream (Buffer Preparation) activities.
• Report and evaluate production deviations and investigate critical deviations.
• Ensure initial and ongoing training of Downstream personnel is carried out as needed.

Skills

Communication

Teamwork

Problem solving

Decision making

Education

Bachelor’s Degree in Chemical Engineering

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 Buffer Preparation Area / Purification/Reaction.
• To execute equipment qualification protocols and validation protocols.
• To perform and document operations in accordance with cGMP.
• Maintenance and calibration of production equipment and instrumentation in co-ordination with maintenance department.
• To comply with EHS policies and procedures.
• Responsible for OTIF execution of all the activities related to Downstream (Buffer Preparation).
• To ensure that all production deviation are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.
• To ensure that the required initial and continuing training of PDS-Downstream personnel is carried out and adapted according to need.
• Preparation or modification of Batch Manufacturing Records, SOP, EOP, Checklists, Log Sheets and related documents.
• Data owner for process equipment used in day-to-day activity.
• Bachelor’s Degree in Chemical Engineering is mandatory
• 1 - 3 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations
• Good in soft skill such as communication and team work.
• Good in Problem solving and decision making