MS DSP Senior Laboratory Specialist

Vor 2 Tagen

Neuenburg, Schweiz Takeda Pharmaceuticals Vollzeit

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Job Description

Job Title: MS Senior Laboratory Specialist DSP Position

Location: CHE - Neuchâtel

Primary Duties

The Manufacturing Science (MSci) department is the owner of the process; hence this team of Subject Matter Experts (SMEs) is a key player for all complex issues or projects involving the product.

MSci Senior Laboratory Specialist DSP is the SME for the lab scale product/process at Neuchatel and covers the planning and execution of "scale down" purification activities, support to the DSP laboratory team regarding protocol execution, troubleshooting, and process robustness improvement projects at laboratory scale.

  • Perform the following tasks as support to another team member, as coach, or as project lead:
    • Planning and execution of "scale down" purification activities
    • Complex investigations and product impact assessment in protocols/studies deviations related to product
    • Process/equipment improvement projects including technology transfer
    • Small scale/scale down product validation activities
    • Writing and review of reports/documents
  • Perform relevant escalation/communication of critical issues
  • Ensure efficient lab scale project performances through Quality by Design (QbD) and Continuous Process Improvement approaches
  • Train and coach new lab members
  • Manage documentation associated with laboratory activities
  • Control the laboratory equipment placed under responsibility, ensure their maintenance, and solve operating problems independently
  • Manage stocks and inventory of consumables necessary for laboratory activities and participate in laboratory logistics

Responsibilities

  • Execute small scale purification studies: purification, ultrafiltration, diafiltration
  • Execute column packing operations with different resins (0.5 to 10cm diameter)
  • Execute protocols according to laboratory management or project lead requirements/directions
  • Write development, investigation, process qualification protocols
  • Collect, summarize, and analyze data to prepare reports and presentations
  • Lead investigations related to lab deviations
  • Project management
  • Evaluate and implement innovations in the area of expertise to deliver better performing solutions
  • Develop and optimize process parameters
  • Manage documentation associated with laboratory activities
  • Control laboratory equipment, ensure maintenance, and solve operating problems independently
  • Manage stocks and inventory of consumables necessary for laboratory activities

Critical / Key Skills:

- Master in biochemistry, biotechnology, or relevant scientific discipline.

- Minimum 5 years of experience in the pharmaceutical industry, ideally in process development.

- Good knowledge of a GMP environment and quality requirements.

- Extensive experience and theoretical knowledge of proteins and chromatography/UF processes.

- Strong communication skills and team spirit, with the ability to effectively communicate at multiple levels in the organization.

Language & IT Skills:

  • Fluent in French and level of English C1/2
  • Good knowledge of Unicorn software
  • Good knowledge of the Windows environment and Microsoft Office suite
  • Knowledge of Minitab software is a plus
  • Basic LIMS and Trackwise knowledge

TAKEDA LEADERSHIP BEHAVIORS

  • Demonstrates strategic enterprise thinking
  • Creates an environment that inspires and enables people
  • Focuses on priorities and delivers superior results
  • Elevates capabilities of the organization for now and the future

KEY TECHNICAL SKILLS AND COMPETENCIES

  • Strong knowledge of recombinant protein purification and scale down.
  • Hands-on experience in chromatography/UF processes.
  • Good knowledge of recombinant protein analytical methods.
  • Knowledge in cell culture and statistics is a plus.
  • Basic knowledge of quality systems (Trackwise, LIMS).
  • Experience in installation and qualification of lab equipment.
  • Strong organizational and follow-up skills, as well as attention to detail.

Complexity and Problem Solving

  • Able to deal with statistics and scientific data.
  • Strong analytical and problem-solving skills regarding purification issues, scale up/scale down issues, and analytical issues.
  • Ability to make data-driven decisions promptly and appropriately in complex situations.
  • Ability to manage multiple priorities.

Internal and External Contacts

  • Collaboration with Manufacturing Science teams across various locations
  • Quality control teams in Neuchâtel, Vienna, and Orth
  • Collaboration with departments such as Automation, Metrology, ISS, Manufacturing, QA, and Engineering

Other Job Requirements

Hands-on experience working in a laboratory environment with a strong EHS and GxP mindset.

Find out more about Takeda Neuchâtel:

With over 700 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel, and a leading biopharmaceutical production site in Switzerland.

Takeda Neuchâtel is certified as a Training Company by the Swiss State Secretariat for Economic Affairs.

“Giving our employees the means to shine”:

Takeda is committed to creating a diverse workforce and providing opportunities for all employees and job applicants.

Locations: CHE - Neuchatel Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time #J-18808-Ljbffr

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