job description
Join GSK, a global leader in healthcare innovation, as a Senior Biotechnologist in our cutting-edge manufacturing operations. This contract role (until 30 November 2027) offers a unique opportunity to contribute to the end-to-end production setup of biopharmaceutical processes in a dynamic, high-impact environment.
Based in Badung, Bali, you will play a pivotal role in ensuring operational excellence, compliance with GMP/GLP standards, and the seamless scaling of biotech manufacturing processes. This position is ideal for professionals passionate about advancing biotechnology, process optimization, and regulatory compliance in a world-class facility.
GSK is committed to fostering a diverse and inclusive workplace where innovation thrives. If you are a detail-oriented biotechnologist with a track record in manufacturing, quality control, or process development, we invite you to apply and be part of our mission to deliver life-changing medicines.
Responsibility
- Lead the setup, validation, and optimization of biopharmaceutical production processes in compliance with cGMP and regulatory guidelines.
- Collaborate with cross-functional teams (QA, QC, Engineering) to ensure end-to-end operational readiness for manufacturing scale-up.
- Develop and implement SOPs, batch records, and technical protocols for biotech operations, ensuring adherence to GSKās quality standards.
- Monitor and troubleshoot bioreactor, purification, and fill-finish processes to maintain efficiency and product integrity.
- Support technology transfer activities from R&D to commercial manufacturing, including risk assessments and process improvements.
- Conduct data analysis and trend reporting to identify opportunities for yield enhancement and cost reduction.
- Train and mentor junior staff on bioprocess techniques, safety protocols, and compliance requirements.
- Participate in audits, inspections, and CAPA investigations to maintain regulatory compliance (e.g., FDA, EMA, PIC/S).
Qualifications
- Bachelorās or Masterās degree in Biotechnology, Biochemical Engineering, Molecular Biology, or a related field.
- Minimum 5+ years of experience in biopharmaceutical manufacturing, preferably in a GMP environment.
- Proven expertise in upstream/downstream processing (e.g., cell culture, fermentation, chromatography, filtration).
- Strong knowledge of regulatory requirements (cGMP, ICH, 21 CFR) and experience with process validation.
- Hands-on experience with bioreactors, single-use systems, and analytical instruments (e.g., HPLC, ELISA).
- Excellent problem-solving and documentation skills, with attention to detail in a fast-paced setting.
- Familiarity with Lean Six Sigma or continuous improvement methodologies is a plus.
- Ability to work independently and collaboratively in a multicultural, contract-based environment.