*Manager, Operational readiness, MFG Documentation
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Our site in Søborg is currently seeing large growth and as a result, we are expanding our production capacity. This means that we are on the verge of a very exciting chapter of AGC CPH’s history. You will have the chance to participate in bringing a new state of the art, and fully disposable Mammalian manufacturing facility live, as responsible for the readiness of our manufacturing documentation.
Manufacturing is a part of Technical Operations who is also responsible for construction of the new facility, engineering and facility management. The business area currently holds close to 400 employees and aims to increase that number significant over the course of the coming 12-18 months.
Your task will be to own and drive the operational readiness project for all operational documents in MFG, such as SOP’s, Instructions, Logbooks, Batch documentation and change requests. Initially your task will be, to build a small dedicated team and together with your team, work with the stakeholders within Manufacturing to establish an overview of the operational documentation needed to be in place, prior start of operations in Q3 2023. Establish a project plan and related tools, such as dashboards, KPI’s etc. to secure progress, alignment and visibility to the operational readiness.
As the overview and project plan come together you and your team will secure progress of establishing the needed documents in due time. For some documents by being the owner and author (Higher level facility/MFG SOP’s) for others by working with the owners of the documents (Instructions, Logbooks etc.) by providing SME support and/or project management oversight.
Furthermore, your team will support the authority approval of the new facility and you and your team will act as SME’s on the high level facility/MFG SOP’s and related documentation.
As the operational readiness project ramps down and normal operation is initiated, your team will own and maintain the Master Batch Record template, the high level SOP’s, support inspections and audits and support our effort to establish electronic batch records, as the user representative.
The ideal candidate has a strong drive, get things done, embrace changes and is a natural leader with a positive mind and has solid experience with GMP documentation for API Manufacturing.
You will report directly to the Director of MFG Documentation and Training and work closely with all members of the Technical Operations management team.
Your responsibilities:
- Build, lead and develop a dedicated team of skilled MFG documentation SMEs
- Develop, own and drive the operational readiness plan for MFG documentation
- Support authority approval of the new facility
- Support inspections and audits by securing trained and competent SME’s to represent MFG, secure closure and follow up from observations.
- Secure maintenance and GMP compliance of the overall MFG SOP’s and Master Batch Documentation template
- Be responsible for the overall MFG timeliness of documentation updates and reviews
- Build capabilities within your team to support implementation of electronic batch records
Your qualifications:
- Previous leadership experience is preferred
- Experience from a biological API production, most likely in a role within Manufacturing or QA.
- Experience with GMP compliance, SOP’s, Instructions and Master Batch documentation for both clinical and commercial products and facilities
- Experience from audits and inspections
- Ability to understand the need of the people performing daily operation on the floor and secure that your team translate complex and rigid processes in to simple and efficient documents.
- Experience with electronic batch records in one form or the other
- Able to work collaboratively and build relationships with ease and the ability to influence people at all levels.
- A confident communicator with good oral and written communication skills
Personal traits:
- You thrive in a fast pace environment
- You like to optimize and streamline and can act as a change agent
- You have a big personal drive
- You build relationships and enjoy collaborating across professional functions
- You believe that working hard is also about having fun
Your background, educational and professional:
- You hold a MSc in a relevant field
- You possess 5+ years of proven experience within Manufacturing, QA or similar area, working with documentation and GMP compliance
- You have previous leadership experience
- You speak and interact fluently in English, both written and verbal is required.
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.
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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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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 4.7.2022, men kan have været deaktiveret og genaktiveret igen.
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