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Process Transfer Product Steward

We are seeking a technically strong CMC lead to develop phase-appropriate project plans with clients and be an integrator by leading internal teams to deliver high-quality product on time. This is an opportunity for expansion of your leadership and product development skills while contributing to the growth of our business. The product steward will be responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics for late stage & commercial GMP manufacturing. Will work cross functionally with MS&T, 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 a must to be successful in this role!Key Responsibilities:

  • Apply technical and regulatory experience to develop an integrated CMC plan with client and ensure agile delivery by the internal team
  • Critically review technical details and proactively work with internal team and client to resolve issues
  • Track progress against deliverables, timelines, and cost; identify/solve technical, budgetary, and schedule risks to the program and propose appropriate risk response strategies. 
  • Technical Support of Upstream, Downstream and Central Services
  • Generates documents such as batch records, Standard Operating Procedures and Bills of Materials
  • Performs event and minor investigations, assists on Major and Critical and leads CAPA actions plans
  • Writes and Implements change controls
  • Interfaces with clients and is a point of contact during floor operations
  • Represents Manufacturing on Technology Transfers
  • Supports validation activities
  • Project team member on new equipment start up, documents and training
  • Start up and training on new equipment
  • Leads and Supports improvement activities

Education and Competencies:

  • PhD (or MSc with addition experience) in a scientific discipline with several years of experience with biologics product development. Experience in large Pharma and small biotech companies highly desirable.
  • Knowledge of cGMPs and Regulatory requirements related to development and manufacture of biologics. Experience with writing regulatory submission documents.
  • Demonstrated knowledge of multiple disciplines, specifically Analytical and Quality; Formulation and Bioprocessing are a plus.
  • 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.
  • Presentations and documents should provide ‘the story’ in a facile flow, clear conclusions, and a level of detail suitable for reaching technically sound conclusions

AGC Biologics CopenhagenAGC 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 to a large extent 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. 

Application

We cooperate with Adecco on recruitments. Accordingly Adecco will be responsible for the recruitment process. For more information about the position, please contact Adecco's recruitment team.

 

We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will close.

NB. Start date will latest be December, 1st 2020. 

About AGC BiologicsAGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.

AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development.

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


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