Upstream Biotechnologist

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.

Position Overview

We are looking for an Upstream Biotechnologist to support GMP biologics manufacturing activities. The role will be involved in upstream cell culture operations, equipment preparation, process monitoring, sampling, troubleshooting, and GMP documentation.

Key Responsibilities

• Perform and support upstream manufacturing activities, including:
  - Cell thawing and seed train expansion
  - Inoculation and cell culture
  - Bioreactor preparation and operation
  - Harvest preparation and transfer activities
• Monitor critical process parameters such as pH, temperature, dissolved oxygen, agitation and gas flow.
• Perform process sampling and support in-process testing during manufacturing activities.
• Operate and support single-use and/or stainless-steel bioreactors and associated upstream equipment.
• Perform equipment preparation, cleaning and sterilisation activities, including CIP/SIP, where applicable.
• Execute manufacturing activities in accordance with approved SOPs, batch records and GMP requirements.
• Maintain accurate and contemporaneous GMP documentation in accordance with Data Integrity and ALCOA+ principles.
• Support investigation of deviations, process abnormalities and manufacturing issues.
• Participate in CAPA, change control and continuous improvement activities.
• Support process troubleshooting, optimisation and operational readiness activities.
• Support technology transfer, process validation, PPQ and manufacturing start-up activities, where required.
• Work closely with Manufacturing, MSAT, QC, QA and Engineering teams to ensure timely and compliant execution of production activities.

Required Qualifications

• Diploma or Degree in Biotechnology, Biochemistry, Chemical/Biochemical Engineering, Life Sciences or a related discipline.
• Relevant experience in biologics, biotechnology or pharmaceutical manufacturing preferred.
• Hands-on exposure to upstream cell culture and/or bioreactor operations would be advantageous.
• Familiarity with GMP manufacturing practices, batch documentation and data integrity principles.
• Experience with single-use systems, CIP/SIP, aseptic operations, deviation investigations or process validation would be an advantage.
• Able to work effectively in a cross-functional manufacturing environment.
• Good troubleshooting, communication and documentation skills.
• Willingness to support shift work and manufacturing schedules, where required.

Why join us

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.