*MSAT Manager (Scientific Lead)

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AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

In the newly implemented MSAT organization you will work cross functionally with MFG, MSAT, PD, Quality and other organizations. The role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is necessary to be successful in this role!

Summary – MSAT Manager:

As our new MSAT Manager, you will be the technical and scientific lead of the overall GMP manufacturing process of one or several commercial program(s), which may operate across multiple manufacturing sites. You are expected to be the MSAT process owner and scientific gatekeeper involved in all critical tactical and operational issues, major life-cycle management activities (including post-approval submissions), change implementations and product impact assessments

This is a unique opportunity to utilize your product and process understanding, while expanding your informal leadership skills as well as overview of all facets of a commercial program. More importantly, you will be contributing to the timely delivery of life-saving medicines with product quality and patient safety in mind.

Organization and Key Collaborators:

The newly implemented MSAT organization consists of Process Transfer (PD), Process Validation (PV) and Commercial Project Support (CPS). This position resides within Commercial Project Support and you will work internally with peers in MSAT as well as cross functionally with Manufacturing (MFG), Process Development (PD), Quality, Project Management (PM) and other organizations across multiple manufacturing sites. Regular client interactions can also be expected.

Your key responsibilities:

  • Support validation activities, technical writing and regulatory interactions
  • Apply technical and regulatory expertise in support of the project team through all phases of the program
  • Being the overall process owner / Scientific and technical gatekeeper after commercialization
  • Critical review of technical documentation and assessment of process-related change requests
  • Proactively work with internal team and client to resolve critical operational and technical issues
  • Identify technical risks to the program and propose appropriate risk response strategies.
  • Conduct investigations, assist in major and lead CAPA actions plans
  • Interface with customers as one of the key point of contacts
  • Harmonize control strategies and lead change implementation across sites
  • Where relevant, drive and host cross functional and cross-site technical and scientific team forum for process review, knowledge sharing and discussions
  • Where relevant, drive and lead short term technical task forces to solve critical issues impacting one or multiple sites
  • Represent Manufacturing Science and Technology
  • Be a role model and provide guidance for other members of the functional area

Experiences and Skills:

  • PhD (or MSc with 8+ years of proven experience) in a relevant scientific discipline.
  • Relevant experience in large pharma and/or small biotech companies is highly desirable.
  • Knowledge of GMP and regulatory requirements related to development and manufacture of biologics.
  • Demonstrated expertise of multiple disciplines, specifically bioprocessing, analytical chemistry and quality.
  • Maturity to apply scientific and technical knowledge to provide constructive and creative solutions for the advancement of the program in alignment with the client.
  • Ability to use knowledge and interpersonal skills to influence and guide internal team and to build excellent client relations to meet project and business objectives
  • Ability to confront tactical and operational issues with a proactive and pragmatic mindset in a solution-oriented and service minded manner
  • Ability to maintain good overview while being able to conduct deep dive analysis when needed
  • An excellent communicator that can distill complex concepts with clarity of thought in a concise and factual manner.

For further information, please contact Hao Jiang (+45 60253383), [email protected]

We will process the applications on an on-going basis. Therefore, please submit your application Cover Letter and updated CV as soon as possible.

AGC Biologics Copenhagen

AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.

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.


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Jobbet er oprettet på vores service den 18.6.2022, men kan have været deaktiveret og genaktiveret igen.

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