Manufacturing Science And Technology Senior Scientist

Conteúdo do emprego

Are you currently looking to join an innovating, and forward thinking organization based in Basel, Switzerland? Our client is seeking for a senior professional to join their team, as a Manufacturing Science and Technology Senior Scientist. You will be processing various validations, using their GMP manufacturing skills, evaluate studies, and develop, optimize and review Master Batch Records and Batch Records during development.

Responsibilities

• Supporting commercial manufacturing and development activities of Small Molecule Drug Product (primarily Spray dried dispersion) at CMO’s.
• Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process optimization
• Support the drug product team throughout the Process Design, Process Qualification and Continuous Process Verification
• Partnering with other functions to apply e.g. modeling tools ensuring that scale-down/up and characterization of manufacturing processes is robust and scientifically sound leading to a predictable and highly consistent performance and a well characterized process
• Lead/participate in root cause investigations of process related deviations.
• Lead the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements
• Acting as shop-floor support during tech transfer, validation studies and commercial manufacturing
• Develop, optimize and review Master Batch Records and Batch Records during development, clinical supply and transfer to commercial supply.
• Participate in facility fit assessments and gap analysis for the relevant part of the GMP manufacturing.
• Collaborate with Development and manufacturing sites for know-how transfers.
• Initiates and carries out process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance
  

Qualification

• Strong scientific and technical experience within relevant development and/or manufacturing technologies and unit operations relating OSD manufacture.
• Preferably experience with equipment utilized in commercial cGMP manufacturing facilities
• Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
• The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams.
• Experience working with Contract Manufacturing Organizations is desirable, but not mandatory.
• The candidate must demonstrate high levels of integrity.
  

Key Competencies

• Management of complexity, driving for results, problem-solving and collaborating cross-functionally.
• Strong communication skills and computer literacy are essential
• Fluency in spoken and written English is mandatory
• Experience with innovation and operational excellence is desirable
• A good understanding of statistical analysis and continuous process verification is desirable
• Experience in Spray dried dispersion and tableting
• Lean/Six Sigma Green belt certification and statistical knowledge is desirable
  

Job Title: Manufacturing Science And Technology Senior Scientist

Location: Basel, Switzerland

Rate/Salary: 60.00 - 70.00 CHF Hourly

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

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