Specialist - Single Use Systems and Primary Pack for Drug Product

Are you a proactive Specialist thriving with being the go-to person? Do you bring curiosity and a mindset for developing within and mastering complex processes and technologies?

Then we hope you will be our new colleague in our Manufacturing Sciences and Technology for Drug Product (MSAT DP) department.

Your New Role
The area of Single Use systems (SU) and Primary Pack (PP) for DP is very dynamic and developing fast.

This means we do not necessarily require many years of experience with the area. Rather we expect you to have a few or more years of experience with SU and PP and a strong ability to get up to date and stay forward looking on top of trends, developments, and best practices in the area.

You will be the specialist and go-to person. You will provide process, technology, and design support for drug products to be manufactured at FDB – including during engineering runs, qualification, tech transfers and GMP mfg.

Main tasks

• Specialist on Single Use systems for transfer of bulk Drug Substance to formulation room, to filling room to point-of fill. This includes - Single use bags for mixing / pooling and formulation of BDS, - Single use bags for liquid excipients and readymade buffers etc. - Single use transfer bags of weighed powders for closed system addition in formulation room, - Bioburden and Sterile filters incl setups for automated pupsit- bulk DP bags, - filling assemblies incl. surge bag and filling tubes and RTP port bags
• Specialist in Primary containers (syringes, vials, cartridges, and closures including pressfits / snapfits and COP containers.
• Assessments of Primary packaging materials suppliers and SU suppliers processes
• In cooperation with TT leads and other scientists design proper SU systems for the Drug Products to be manufactured, ensuring best control of CQAs and adherence to Product Control and Contamination control strategies.
• Lead and ensure global aligned strategic approach to SU systems and primary pack in the large-scale organsation for Drug Product currently covering FDBD (Denmark) and FDBN (North Carolina).
• In cooperation with customers and other relevant MSAT resources ensure compatibility and E/L is properly assessed and acceptable for the solutions designed and developed for the specific Drug Product programs
• supporting sourcing organization and others with inputs to material specification, incoming release criteria and ensuring proper Risk Profile around handling and assembly of SU systems, including Aseptic connections between SU elements.
• -keeping up to date with trends and regulations in the SU and primary pack space
• representing FDB with presentations on conferences, papers, articles, support to commercial presentations
• driving solution task forces in case of problems with SU systems and primary pack during manufacturing in case mfg. needs further help, and liaise with suppliers if necessary

Skills & Talents

• experience from the pharmaceutical industry working in a GMP environment.
• previous experience with SU and PP.
• experience from working with process designs and Quality Risk Management
• strong interest and bandwidth for continually learning about new technologies, processes, and products.
• -Strong communication skills in English

We hope you are self-driven, proactively and excel in managing complex assignments.

Your New Team
The MSAT DP department contains the drug product process and technology scientists/specialists, as well as the tech transfer leads, the CQV specialists and the non-GMP lab process analysts. We are currently more than 15 colleagues and will be growing over the coming years as we transition into GMP drug product manufacturing operations. We work in an informal way with highlight on trust, meaning, humor, delegation, proactivity and learning and sharing between each other.

We are team players and people who like details without losing sight of the big picture. The work environment is international. We keep a high pace and focus on a vital work life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

For our new drug product manufacturing facility in Hillerød, we are currently establishing full SU processes around thaw, formulation and fill for DP. We are simultaneously establishing similar setup in North Carolina, US which will also be supported form MSAT DP in Hillerød. We also have a non-GMP DP lab currently located in The Science Park in Hørsholm where we can test and experiment with SU and PP for the Drug Products.

Application
Has this sparked your interest? Then we urge you to apply as soon as possible as we continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate. If you have questions about the job, please contact Director Henrik Hermann 25663055

The Company
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 work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

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.

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.

Location: FDBD Hillerod