PQM Scientist (QC)

Job title:

PQM Scientist (QC)

Company:

Fujifilm

Job description

Do you have QC & QA experience from manufacturing sites (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right quality level for our customers and keeping them updated on the testing and manufacturing of their products? Then you might be the key person we are looking for!Come share our passion, drive, and energy – what we call Genki – and be part of the Program Quality Management team (PQM QC) at FUJIFILM Diosynth Biotechnologies. You’ll play an important role in building relationships with our customers. With a fast-expanding site, our team is growing to support our increased number of customers. In this position, you will be accountable for communicating quality-related topics affecting customer programs for testing in QC. This communication is based on the responsibilities defined in the Quality Agreement (QUAG).About the PositionWe work with various biopharma companies, which means each project brings a unique set of challenges. In this role, you are a link between our customers and the FDB team. You will be involved in different quality-related topics affecting customer programs and ensure customers are informed and involved to instill confidence in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. You will help identify opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest integrity and impact.Job ResponsibilitiesYour primary tasks will include but are not limited to:

• Being the primary point of contact for customers regarding assessment and communication on Deviations, Change Controls, and CAPAs, and various ad hoc requests for QC.
• Performing impact assessments of change controls and deviations against Quality Agreement requirements related to QC and raw materials.
• Preparing data for Quality Management Review meetings and other reporting structures.
• Establishing, developing, and maintaining department documents: customer presentations, SOPs, and participating in our internal Continuous Improvement activities.
• Handling ad hoc tasks.

About FUJIFILM Diosynth Biotechnologies and Our Quality Control DepartmentFUJIFILM Diosynth Biotechnologies is a world-leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our vision as a company is “Advancing Tomorrow’s Medicines.” This is a goal that we collectively strive towards, and we look forward to you joining us on this exciting journey.Our Quality Control (QC) department at the Hillerød site consists of approximately 240 employees divided into different support teams and five testing teams. In QC, we strive towards a OneQC team spirit where we help and support each other across teams, not only to achieve our goals but also to support a high level of collaboration and personal development opportunities. The pillar of our QC department is our employees – our success is only possible due to competent and dedicated colleagues who want to make a difference for QC, our site, our customers, and patients globally.The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees, and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, the possibility to work from home, and most recently, we invested in a mobile barista coffee van. FDBD also has a canteen arrangement including Friday brunch and monthly afternoon cake, and we have a “bell ringing” tradition for reaching important milestones. In all, we value a sense of community in the workplace and have implemented traditions and routines that nurture this concept.The Program/Project Manager structure at FDBD is structured with an overall PM handling direct customer contact and overseeing manufacturing activities as well as some QA/QC activities. In this role, you will be the QC Product Quality Manager, a title that allows for distinction between the QA and QC functions within the FDBD organization. You will act as the designated QC PQM responsible for an overview of all QC-related activities while also managing the interdependencies between several departments related to and dependent upon QC. This role is deeply rooted in coordination and collaboration, offering a great opportunity to develop a network across the organization. As FDBD is growing, we are developing and refining our processes to streamline the customer experience.Professional and Personal QualificationsThe candidate should hold a bachelor’s or master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or similar fields, with an interest in and knowledge of GMP and quality systems, with a minimum of 2 years of relevant QC and ideally QA experience. You are positive and organized with attention to detail, yet able to keep an overview in a changing environment. You are service-minded with excellent verbal and written communication skills. Fluency in English is required as English is our corporate language.At FDBD, we put people first and always look for candidates with the right combination of personality and skills. FUJIFILM Diosynth Biotechnologies, like any modern company, requires agility and flexibility from employees from time to time, but we ensure a controlled work-life balance. We encompass many different nationalities and personalities at FDBD, and for us to succeed, we all need to focus on communication, take responsibility, organize, execute various tasks, solve problems, and display great interpersonal skills.ApplicationHas this sparked your interest? We urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we find the right candidate. If you have any questions, please do not hesitate to contact Head of Product Quality Management for QC, Rikke Hedegaard, mobile +45 91357105.FUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.Shape the future with us—your drive meets boundless opportunity hereFUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid

Expected salary

Location

Hillerød, Hovedstaden

Job date

Sun, 23 Feb 2025 02:02:26 GMT

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