MSAT Tech Transfer Senior Scientist

WuXi Biologics; Wuppertal; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical firm in Wuppertal seeks a Tech Transfer Senior Scientist to oversee technology transfer and process validation. Candidates should possess at least 6 years of experience in Upstream and/or Downstream operations. Responsibilities include conducting technology transfer activities and planning commercial process validations. The successful candidate will collaborate with cross-functional teams to ensure compliance and operational efficiency. A background in biotechnology or related fields, along with strong communication skills, is essential for this role.

Qualifikationen

• Minimum of 6 years practical experience in Upstream and/or Downstream operations.
• Solid knowledge of bioprocesses and application of current Good Manufacturing Practices (cGMP).
• Proven experience in new product technology transfers into a clinical and/or commercial facility.

Aufgaben

• Conduct technology transfer and/or process validation activities.
• Plan and execute commercial process validation including supporting studies.
• Collaborate cross-functionally to ensure seamless process adoption.

Kenntnisse

Hands-on experience with mammalian cell culture

Strong attention to detail

Effective presentation and communication skills

Ausbildung

Bachelor of Science in Biotechnology, Biological Sciences, or related

Doctorate degree (Ph.D.) in Biotechnology or related (preferred)

Jobbeschreibung

Overview

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.

Responsibilities

• Conduct technology transfer and/or process validation activities in both upstream and downstream processes as required aligned with your specific technical expertise.
• Lead New Product Introduction efforts and Gap Analysis & Risk Assessments as well as execute small- to pilot-scale confirmation runs to ensure successful technology transfer from sending unit to manufacturing site.
• Plan and execute commercial process validation including supporting studies and CPV to ensure GMP-compliant process robustness.
• Directly support large-scale manufacturing campaigns by executing and evaluating satellite runs as well as driving troubleshooting activities, deviation investigations, and CAPA implementation.
• Collaborate cross-functionally with manufacturing, supply chain, quality control, quality assurance, and process development teams to ensure seamless process adoption and compliance.
• Support both Upstream and Downstream processes as needed based on project requirements and professional specialization.

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

• Demonstrate hands-on experience with mammalian cell culture and/or purification processes (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 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 organization 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.
• Strong focus and attention to detail; good problem-solving skills; ability to work independently and in cross-functional teams; effective presentation and communication skills.
• Works well with others and builds good teamwork. High customer orientation and commitment to quality.
• Must be willing to travel if required to fulfil the responsibilities of the position.

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!

Would you like to know more before you apply? Please visit us at. WuXi Biologics is an equal opportunities employer.

Required Experience: Senior IC

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.

• Conduct 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.

Address

Would you like to know more before you apply Please visit us at . WuXi Biologics is an equal opportunities employer.