Senior QC Coordinator in Analytical Development
1 month ago
Are you passionate about project management, have experience with Tech Transfer and are enthusiastic about contributing to a rapidly developing CDMO? Then we can offer an exciting and challenging job in a company with a very exciting future and many partners and products. We have great opportunities for personal development, and our future is exciting and promising.
We are expanding our large-scale facility to encompass 20 x 20,000L bioreactors for Drug Substance production. We are well in-progress on building our first Filling Facility in Denmark. Hence, we are looking for people with “Genki”, which is one of our four values, it’s Japanese for passion, energy, and fun. We believe in teamwork, a variety of tasks and giving responsibility to those closest to the work. We believe in people
About the Position
We are looking for an Analytical Project Manager with focus on Drug Substance (DS) and Drug Product (DP) methods who will play a key role in the implementation of test methods to support clinical phase III and Process Performance Qualification (PPQ) technology transfer programs. We work in a high paced and dynamic environment where we support the biologics DS/DP production as well as the global release of commercial products for our clients.
The QC department in Hillerød consists of approximately 230 employees divided into four departments: Analytical Development (AD), Testing Teams, Laboratory Support and Raw Materials. You will be part of the QC AD Projects team in the AD department. The team consists of seven highly skilled and dedicated colleagues.
You will coordinate the method transfer activities that relates to a given customer program. That include our QC laboratory and customer relation department as well as contract laboratory organizations to continuously focus and prioritize tasks according to deadlines. You will call for and lead meetings to monitor progress, to share status on project milestones and to facilitate mitigating activities. It is therefore of utmost importance that you have eminent communication and collaboration skills and that you can ensure engagement, motivation, and recognition of your many stakeholders.
Primary Responsibilities
- Lead meetings with our customers as well as internal QC meetings to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines
- Generate transfer plans, transfer summary reports and change control in relation to method transfers
- Review transfer/validation/qualification protocols and reports
- Lead and contribute to optimization projects supporting best Tech Transfer, e.g., proactive project management, problem solving, knowledge sharing, stakeholder management, etc.
Qualifications and Education
- Master of Science within Pharmaceutical Sciences, Biochemistry, Protein Chemistry, Biology or similar relevant education
- Experience with cGMP QC laboratory, pharmacopoeias, and ICH guidelines
- Experience with project management
- A strong scientific background and preferably experience with method transfer and validation
- Documented ability to ensure strong stakeholder focus and to prioritize and adapt to business needs
On a personal level you are
- Self-driven, dedicated, and systematic and plan your projects and deliverables in a structured way
- Motivated by finding solutions and actively contributing to a good collaborative environment
- Flexible with a positive attitude, energy, and humour
- Open for changes and interested in developing yourself, the team and organization
- Welcoming working-from-home on a regularly base
- Has excellent English oral and written communication skills
About the QC Department
In QC we strive towards a OneQC team spirit, where we help and support each other across teams not only to reach our goals but to support a high level of collaboration and possibilities for personal development. The pillar in our QC department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for QC, our site, our customers, and patients all over the globe.
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies (FDBD) is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. In case you have any questions, please do not hesitate to reach out to Manager of QC Projects Team in AD, Solveig Vibe,
We will continuously invite relevant candidates for job interviews and will close the job advertisement as soon as we have found the right candidate.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
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