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reference: 5004735

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stillingsbetegnelse: QC Bioassay Manager / Director

jobbeskrivelse:

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.

 

QC Bioassay Manager / Director                                            

Do you want to set direction for the QC Bioassay area in AGC Biologics? As our new QC Chromatography Manager, you will help us develop and manufacture safe and sustainable biopharmaceutical products that improve lives around the world.

You will be involved in a range of exciting tasks and challenges as you lead all QC Bioassay related activities including personnel management, strategic development and customer specific projects.

It is a great opportunity to make the most of your expertise and passion for Bioassays and become a liked and trusted leader among your new colleagues.

AGC Biologics 
At AGC Biologics, we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical and commercial testing. AGC has laboratories in Denmark, US, Japan and Germany. Our customers include large pharmaceutical organisations and research labs that need our expertise and facilities to ensure approved and safe production.

At AGC Denmark, 350 employees do their best to create an informal and easy-going work environment where we respect each other and our differences.

Lead the QC Bioassay department and ensure high-quality customer projects
You will be a part of the QC laboratory where it is your responsibility to lead scientists, the team lead for laboratory technicians and the laboratory operations team. Your working day is characterised by ongoing collaborations with stakeholders such as customers, project managers, business development, management, your department and analytical development.

Along with your department you will manage the QC Bioassay aspect of customer projects, identify, and manage the analytical packages needed for the projects.  You will use your expertise to motivate, challenge and guide your employees to be a high performing quality team. However, you will also have the skill set to pinch in and help with actual quality tasks and together with the other QC leaders ensuring the overview of the work to come. Together, you will play a large part in the quality control of our five production lines. In relation to this, your responsibilities involve:

• Ensuring cGMP compliance with relevant guidelines (EU, FDA)

• Managing the Bioassay part of analytical validation projects in close cooperation with PM and external customers

• Establishing robust QC Bioassay testi ng and project support processes

• Ensuring that the QC Bioassay department is ready for US FDA and EMA inspections

• Ensuring that we meet regulatory requirements for analytical method phase appropriate validation and testing during clinical phases 1-3 and commercial manufacturing

You will administer all aspects of personnel management for your direct reports and play a central part in the recruitment and development of your colleagues. Furthermore, you will provide leadership and guidance to the QC Bioassay department during customer audits and FDA/EMA inspections.

Proactive leader 
To be successful, it is important that you have the necessary management skills to drive a first-class QC Bioassay department. You approach your task with an open mind and enjoy problem solving along with many different stakeholders, and you are flexible in regards to working hours to meet business objectives.

More specifically, you have:

• An academic degree or PhD (preferably in life science)

• 4+ years of relevant experience in the pharmaceutical or biopharmaceutical industry

• Sound knowledge of Bioassay methods and cGMP

• The ability to communicate clearly in English – both in speech and writing

• Demonstrated experience in driving continuous improvement and/or productivity programs

Interested?
Send your application as soon as possible and no later than July 7^th. We treat the applications as we receive them, and conduct interviews with qualified applicants before the deadline.

Based on experience of the right candidate the position will be either a manager or a director position.

If you need further information about the position, please feel free to contact Casper Berg, Director of Quality Control, at +45 4137 7913

We look forward to hearing from you.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3213

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: AGC Biologics A/S

source: DK-STAR