MS DSP Senior Laboratory Specialist

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Job Description

Job Title: MS Senior laboratory specialist DSP position

CHE - Neuchâtel

Primary Duties

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

MSci Senior Laboratory Specialist DSP is SME (Subject Matter Expert) for the lab scale product/process at Neuchatel and covers the planning and execution of "scale down" purification activities, the support to DSP laboratory team regarding protocol execution, troubleshooting (solve production problems with performance or quality impacts) 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 of reports /review of documents and reports
• Perform relevant escalation/communication of critical issues
• Ensure efficient lab scale projects 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 her/his responsibility, ensure their maintenance, and solve the operating problems already encountered independently.
• Manage the stocks and the inventory of the consumables necessary for the realization of laboratory activities and participate in the laboratory logistic activities.

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 (development, investigation, process qualification)
• Write development, investigation, process qualification protocol
• Collects, summarizes, and analyzes data to prepare reports and presentations
• Lead investigation link to lab deviation
• Project management
• Perform relevant escalation/communication of critical issues
• 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 the laboratory equipment placed under her/his responsibility, ensure their maintenance, and solve the operating problems already encountered independently
• Manage the stocks and the inventory of the consumables necessary for the realization of laboratory activities and participate to the laboratory logistic activities.

Critical / Key skills (Compétences critiques / clés) :

- Master in biochemistry, biotechnology or relevant scientific discipline.

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

- Good knowledge of a GMP environment (Knowledge of a GMP environment) and quality requirements.

- Extensive experience and theoretical knowledge of proteins and chromatography/ UF (Ultrafiltration) process.

- Strong communication skills and team spirit (ability to listen, diplomacy, initiative…) with ability to effectively communicate at multiple levels in the organization.

Language & IT Skills (Compétences linguistiques et informatiques):

• Fluent in French and level of English C1/2
• Good knowledges 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, finding innovative ways to serve patients and build trust, reputation and business
• Creates the environment that inspires and enables people to move the organization forward (Takeda-ism, collaboration)
• Focuses on the few priorities and delivers superior results (courageous)
• Elevates capabilities of the organization for now and the future (proactive, passion for excellence)

KEY TECHNICAL SKILLS AND COMPETENCIES

• Strong knowledge of recombinant protein purification and scale down.
• Hands-on experience in chromatography/ UF (Ultrafiltration) process.
• Good knowledge of recombinant protein analytical methods (Activity, ELISA, SDS…).
• Knowledge in Cell culture and statistics is a plus.
• Basic knowledge of quality system (trackwise, LIMS).
• Experience in installation and qualification of lab equipment.
• Strong organizational and follow-up skills, as well as attention to detail.
• Strong communication skills and team spirit (ability to listen, diplomacy, initiative…) with ability to effectively communicate at multiple levels in the organization.

Complexity and Problem Solving

• Able to deal with statistics and scientific data.
• Stong analytical and problem-solving skills regarding purification issue (pressure, yield etc…), scale up/scale down issue, and analytical issue (activity test, ELISA, SDS page etc...).
• Scale down model design and qualification to be representative of Manufacturing scale.
• Ability to make data driven decisions promptly and appropriately in complex situations.
• Ability to manage multiple priorities.
• Perform relevant escalation/ communication of critical issues.

Internal and External Contacts

• Mostly with Manufacturing science Neuchatel, Singapore and Thousand Oaks but also occasionnaly with other Manufactruring science teams from other sites
• Quality control Neuchatel, Vienna and Orth
• Locally with all departements Automation, Metrologie, ISS, Manufacturing, QA, Engineering…
• GMSCi Pharm Science Vienna

Other Job Requirements

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

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 one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site employs a wide range of professionals trained in biotechnologies and their application to industrial production.

With over twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted in and committed to its local ecosystem.

Takeda Neuchâtel is certified as a Training Company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, logistics, IT and biopharmaceutical production.

“Giving our employees the means to shine":

Takeda is proud of its commitment to creating a diverse workforce and providing opportunities for employees and job applicants without regard to skin color, religion, gender, sexual d, gender identity, gender expression, parental status, national origin, citizenship status, genetic information or characteristics, marital status or any other protected by law.

Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time