Scientist, Downstream Mammalian Manufacturing

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Do you want to work with protein purification steps in a large scale manufacturing process? Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.

We have an opportunity for a Scientist/Principal Scientist Downstream Manufacturing to join the Mammalian Manufacturing team at AGC Biologics. This position requires technical problem-solving, process understanding and inter-departmental collaboration. The team is responsible for the preparation and process upscaling, manufacturing support, and implementation of new processes, technologies and systems used in GMP operations.


PRINCIPAL RESPONSIBILITIES:

  • Serve as Downstream Mammalian Manufacturing representative on client project teams.
  • Support/Lead resolution of deviations, investigations, and process issues.
  • Network with Process Development, Process Transfer, and Quality team members to ensure reliable state to process control, and drive continuous improvements.
  • Participate/lead in review and analysis of manufacturing campaign data trending, and present daily progress, as well as end of campaign status updates.
  • Support/ lead emergent events response for on-floor manufacturing issues.
  • Generate and maintain documents related to GMP Manufacturing executions, product impact assessments, and campaign summary reports.
  • Define or provide user requirements for process equipment associated with multiple facilities for the manufacture of biologic Bulk Drug Substance(s).
  • Provide technical/process support to Manufacturing technicians and other departments associated with GMP operations.
  • Serve as the process Subject Matter Expert; provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
  • Participate in the project team meetings, decisions, and creation of milestones representing Mammalian Manufacturing.
  • Prepare and present data associated with manufacturing processes to internal and external clients.
  • Process training, as needed, in adherence to company policies and quality requirements.


KNOWLEDGE, SKILLS & ABILITIES:

  • Working knowledge of Downstream/protein purification unit operations.
  • Well-experienced with operations of single-use technologies and aseptic processing.
  • Must be self-motivated, organized and proactive.
  • Demonstrated ability to interface/communicate extensively with internal and external clients.
  • Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Development, Engineering, QA, QC, etc.).
  • Proven experience successfully participating in multiple projects simultaneously.
  • Demonstrated ability to build effective working relationships across departments (Manufacturing, QA, Process Development, Project Management and Business Development) to support processes and products.
  • Demonstrated experience leading troubleshooting efforts.
  • Ability to provide training to others on GMP manufacturing operations.
  • Strong communication skills necessary to interact with internal stakeholders.
  • Strong presentation skills.


EDUCATION/EXPERIENCE:

The ideal candidate holds an Academic degree within science and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:

  • Master’s Degree in Engineering or Protein Science-related field
  • Experience in downstream/ protein purification operations, preferably in clinical/commercial GMP manufacturing.
  • Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
  • Have experience writing, reviewing and approving GMP documentation.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and humorous working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than March 4th 2022.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 9.2.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København
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