Associate Director for QC Microbiology and Environmental Monitoring

Job title:

Associate Director for QC Microbiology and Environmental Monitoring

Company:

Fujifilm

Job description

Are you a people manager and eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for an Associate Director who shares our passion, drive, and energy – what we call Genki.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 overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey.Our Quality Control (QC) department at site Hillerød consists of approximately 240 employees divided into different support teams and three testing teams. 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 also 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. As a leading CDMO company we, in QC, are obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.The culture at FUJIFILM Denmark (FDBD) is key, and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.About the DepartmentThe QC Microbiology department currently consists of
50 dedicated employees (analysts, scientists, student helpers, and a leadership team). The department consists of 5 teams and supports the global release of commercial products (DS/DP) for our customers with various pharmacopeia Microbiology methods (e.g. Bioburden, Endotoxin, CCI, SVP, BacT, microbial ID etc), as well as supporting the biologic Drug Substance (DS) manufacturing during investigations and with environmental monitoring (EM) and utility monitoring (UM) of the facility. Method suitability testing (MST) and concurrent qualification of the customers samples during the production are becoming a key deliverable for the department with the many new customers that FDBD is transferring into the new DS manufacturing facility. Besides supporting DS manufacturing – FDBD are establishing a new a Fill & Finish facility for Drug Product (DP) where the department is heavily involved with EM/UM of the new DP manufacturing facility, as well as implementing sterility testing of DP. Lastly the department are involved in documentation of deviations, CAPAs, invalid assays, OOS and Change Controls and much more. All this is part of our daily activities in respect of getting the commercial products out to the patients.About the PositionWhen working at FUJIFILM Diosynth Biotechnologies Denmark you will, besides from the tasks listed below, onboard new customers and products to the site, build a network across QC and FDBD, support our site expansion project, and assist in finding new and innovative ways of working smarter in a complex everyday life.As an Associate Director for the QC Microbiology department, you will provide direct leadership of a management team of 5 dedicated Associate Managers. The lab technicians are working 7 days a week in normal working hours. You will have two Associate Directors and a Continuous Improvement scientist as colleagues, and together you will provide leadership, establish direction and prioritization to the entire QC testing department, of approximately 100 employees, together with your colleagues and the Director for the QC testing teams. You will ensure that we work in accordance with our core values – trust, delight our customers, Gemba (go see), and Genki (enthusiasm). The department and our organization will continue to expand and adapting due to the site expansion where we in 2025 expect a 3x DS manufacturing and one new DP manufacturing facility on site Hillerød.You will be reporting into the Director of QC Testing Teams.Your primary tasks will be but not limited to:

• Provide leadership and drive development of your department and Associate Managers
• Set direction and structure, ensure motivation in the team, and prioritize tasks
• Manage a growing team and ensure the right competencies in the team
• Ensure cross collaboration and cross training for various tasks to ensure flexibility
• Ensure that we deliver in accordance with our agreements with our customers
• Ensure alignment with your peers across QC and build an efficient and high performing team
• Work closely with your many stakeholders across the site – eg validation department, DS and DP manufacturing departments
• Challenge status quo and drive a continues improvement (CI) culture
• Ensure the right quality level and cGMP compliance, and deliver according to our KPIs
• Proactively secure a healthy work environment with a safety-first culture where we strive to put people first

Professional and Personal QualificationsWe are looking for a people manager with great dedication and who enjoys going above and beyond, and one who knows that this is only done by teamwork. We believe in teamwork, a high degree of delegation, giving responsibility to those closest to the work. We believe in people!The position requires an Associate Director with experience in both people management and the technical areas of QC. You are not expected to be an expert in each area, but you must be able to act as a sparring partner for your managers on the various subjects. Furthermore, experience with or professional training related to operational excellence and lean methodologies is an advantage.As a person you are open, curious, and motivated by succeeding through your department. You meet and greet people with a smile and have a can-do attitude, and work with a humility and respect for the people around you. You have a pragmatic approach and look for solutions with an open and communicative approach, where you listen to understand. You thrive in an operational environment where priorities may shift on short notice, and where you at times must prioritize. Working in a continuously changing environment is appealing to you.It is expected that you hold an academic degree within Pharma, engineering, etc. with experience from biotech or pharmaceutical industry. You have interest and knowledge of GMP and understands the requirements in a cGMP QC laboratory. You have excellent verbal and written English communication skills as English is our corporate language.At FDBD we put people first and we always look for candidates with the right combination of personality and skills. FUJIFILM Diosynth Biotechnologies will, as any other modern company, ask our employees for agility and flexibility from time to time but we always make sure to have a controlled work-life balance. We are many different nationalities and personalities at FDBD and for us to succeed we all need to focus on communication, take responsibility, organize, and execute on various tasks, solve problems, and display great interpersonal skills.To learn more about the leadership philosophy at FUJIFILM Diosynth Biotechnologies, you can hear a Podcast with our President & CEO Lars Petersen at “Finans Podcast”: (Danish only)ApplicationHas this sparked your interest? Then 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 have found the right candidate.In case you have any questions, please do not hesitate to contact Director, Dinah Adeltoft +45 91 33 74 03About FUJIFILM Diosynth BiotechnologiesFUJIFILM 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, 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

Wed, 04 Dec 2024 23:44:26 GMT

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