MSAT Tech Transfer Senior Scientist

MSAT Tech Transfer Senior Scientist

As Tech Transfer Senior Scientist you will play a critical role in supporting biopharmaceutical technology transfer process confirmation implementation and validation activities. You will be engaged at the forefront of scientific and medical innovation and collaborating closely with renowned international clients in the biopharmaceutical industry. Your scope of work includes the design and execution of laboratory-based studies to ensure manufacturing processes are efficient and robust thereby contributing significantly to the manufacturing of life-saving drugs for patients worldwide.

You will serve as a Subject Matter Expert (SME) in Upstream and/or Downstream bioprocessing technologies providing technical guidance and scientific expertise. Your primary responsibilities include:

• Conducting technology transfer and/or process validation activities in both upstream and downstream processes as required aligned with your specific technical expertise.
• Leading New Product Introduction efforts and Gap Analysis & Risk Assessments as well as executing small- to pilot-scale confirmation runs to ensure successful technology transfer from sending unit to manufacturing site.
• Planning and execution of commercial process validation including supporting studies and CPV to ensure GMP-compliant process robustness.
• Direct support of large-scale manufacturing campaigns by executing and evaluating satellite runs as well as driving troubleshooting activities deviation investigation and CAPA implementation.
• Collaborating cross-functionally with manufacturing supply chain quality control quality assurance and process development teams to ensure seamless process adoption and compliance.
• Flexibility to support both upstream and downstream processes is essential depending on project needs and your professional specialisation.

Department Description

As Tech Transfer Senior Scientist you will be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing lives. In this role you will report to the MSAT Team Lead.

Essential Duties and responsibilities will include:

• Demonstrate hands-on experience with mammalian cell culture and/or purification process (including perfusion or fed batch operations) adhering to regulatory and quality requirements.
• Serve as a Subject Matter Expert (SME) in Upstream and/or Downstream bioprocessing providing expertise in technology transfer process validation CPV manufacturing troubleshooting and scientific investigations.
• Design comprehensive process transfer and validation strategies. Create related protocols reports and other technical documents ensuring regulatory compliance.
• Supervise and execute laboratory studies and related in-process analytical work. Manage experiments independently and collaborate with supervisors on complex studies in alignment with protocols or SOPs.
• Conduct robust statistical data analysis on process data including trend identification charting and linear regression to support decision-making and continuous process improvements.
• Provide critical support during facility ramp-up phases by generating related documents qualifying MSAT laboratory equipment and helping to establish the MSAT function infrastructure.
• Lead and facilitate risk assessments in support of facility fit assessments and new product introductions ensuring technical readiness for process transfers.
• Lead root cause analysis and scientific investigations and implement corrective and preventive actions (CAPA).
• Ensure all tasks comply strictly with GMP standards SOPs and good documentation practice to maintain quality and safety standards.
• Actively support and lead internal and external audits and regulatory inspections to ensure compliance and manufacturing readiness.
• Exhibit flexibility to undertake additional duties and responsibilities as assigned by management to support organizational goals.
• Serve as a role model within the MSAT function and across the organisation by upholding WuXi corporate core values and embracing the PROUD culture.

Person Specification:

Qualifications:

• Bachelor of Science degree in Biotechnology Biological Sciences or a related scientific discipline with a minimum 2 years of relevant working experience.
• A Doctorate degree (Ph.D.) in Biotechnology or a related scientific discipline is preferred.
• Strong academic background in bioprocess engineering molecular biology or related fields is advantageous.

Technical Competencies/Experience Required:

• Minimum of 6 years practical experience in Upstream and/or Downstream operations within a biotechnological environment; level of responsibility and seniority will align with individual experience and expertise.
• Solid knowledge of Upstream and/or Downstream bioprocesses coupled with a comprehensive understanding and application of current Good Manufacturing Practices (cGMP).
• Proven practical experience in new product technology transfers into a clinical and/or commercial facility.
• Experience in designing and executing process validation studies including drafting and reviewing associated protocols and validation reports is highly advantageous.
• Hands-on experience in either Upstream or Downstream operations including:

• Upstream: Aseptic techniques operating bioreactors (experience with mammalian cell cultures is preferred).
• Downstream: Column Chromatography depth filtration ultrafiltration/diafiltration virus filtration and other downstream unit operations.

• Proficient in protocol and report writing as well as data analysis to support process understanding and compliance activities.
• Proficient English language skills demonstrating the ability to understand communicate and document complex scientific information clearly and accurately.

Behavioural Competencies

• Strong focus and attention to detail.
• Good problem-solving skills.
• Able to work independently and in cross-functional teams to meet mutual goals.
• Effective presentation and communication skills.
• Works well with others and builds good teamwork.
• High customer orientation and commitment to quality.

Onerous requirements

• Must be willing to travel if required to fulfil the responsibilities of the position.

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

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WuXi Biologics is an equal opportunities employer.