Senior MSAT Product Steward
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The Sr. Biopharma Product Steward will be responsible for the technical lead of the overall GMP manufacturing process of a specific program, through the application of broader knowledge of theories and principles utilized to solve operational, as well as commercial GMP manufacturing.
This role will require that you'll interact with stakeholders at all levels across the entire AGC Biologics organization and as the main point of contact for our customers regarding technical and scientific topics. As it is a pivotal role for our new MSAT department, you'll need to possess a broader knowledge of scientific, technical regulatory aspects.
To thrive in this role, you are a person that values a fast-pace and challenging work environment, able to extract the most of information and content from all parties involved and bring new perspectives and ideas to the table. You are also someone that is keen to develop and grow something from scratch, with the ability to endure setbacks at the same time as maintaining an integral and quality driven attitude for our customer centric organization.
This is an opportunity for expansion of your leadership and product development skills while contributing to the growth of our business.
Your key responsibilities and areas of competence:
- Apply technical and regulatory experience in support of the team
- Critically review technical details and proactively work with internal team and client to resolve issues
- Identify/solve technical risks to the program and propose appropriate risk response strategies.
- Interface with customers as key process point of contact
- Represent Manufacturing Science and Technology
- Support validation activities
Your educational and professional background:
- PhD (or MSc with 6+ years of proven experience) in a scientific discipline with at least 10 years of experience with biologics product development.
- 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 knowledge of multiple disciplines, specifically bioprocessing, analytical chemistry and quality.
- Maturity to apply scientific and technical knowledge to provide unique and creative solutions for the advancement of the development 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
- An excellent communicator that can distill complex concepts with clarity of thought in a concise and factual manner.
For further information, please contact Fredrik Nilsson, [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.
Information og data
Denne ledige stilling har jobtypen "Chauffør", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 10.2.2022, men kan have været deaktiveret og genaktiveret igen.
- Chauffør
- København
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