QC Scientist - Maternity Cover

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Massage & physiotherapy

Health check

Fitness center

Friday brunch & canteen

Job summary

FUJIFILM Biotechnologies Denmark ApS is seeking a scientist for the QC Analytical Development team in Hillerød. The role focuses on implementing and transferring analytical methods to support technology transfer programs between customers and FUJIFILM Biotechnologies, including cGMP release testing for DS/DP products.

The ideal candidate holds an MSc or PhD in Pharmaceutical Sciences and has at least 5 years in pharma/biotech, with strong knowledge of analytical techniques (UV, icIEF, CE-SDS,

Qualifications

• MSc or PhD in Pharmaceutical Sciences or related field and at least 5 years in pharma/biotech, preferably QC
• Solid understanding of GXP guidelines (US Pharmacopeia, European Pharmacopoeia, ICH)
• Broad analytical background with experience in multiple methods (UV, SDS-PAGE, icIEF, CE-SDS, SEC, CEX, U/HPLC) and data analysis tools
• Experience with method transfers and validations is a clear advantage
• Proficient in written and spoken English

Responsibilities

• Author and review transfer, qualification and validation protocols, reports and SOPs
• Data analysis and evaluation; troubleshooting methods
• Hand over transferred and validated methods to QC testing teams
• Provide analytical method support to QC testing teams, including OOS investigations
• Change control assessment for method or specification changes
• Support validation and implementation of new instruments with QC Instrument Support
• Ensure compliance with cGMP and participate in audits/inspections as needed

Skills

Analytical methods

English proficiency

GXP knowledge

Method transfer experience

QC environment experience

Education

MSc or PhD in Pharmaceutical Sciences

Tools

JMP

Statistical software

Job description

Are you eager to join a pharmaceutical company, where you can make a difference in advancing tomorrows medicines? And are analytical methods your passion? Then we have a unique opportunity now to join our QC Analytical Development team, as we are looking for a scientist who shares our passion, drive, and energy – what we call Genki. About the position FUJIFILM Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. In order to support our costumers and technology transfer programs, we are looking for a scientist to play a key role in the implementation of multiple chemistry methods to support our technology transfer programs between our customers and FUJIFILM Biotechnologies. We work in a high paced and dynamic environment where we support the biologics Drug Substance (DS) production by implementation of methods like UV, SoloVPE, SDS-PAGE, icIEF, CE-SDS, SEC, CEX, icIEF, U/HPLC-based methods, PS80, Titer and PepMap. In addition, we support the global release of commercial products (both DS and Drug Product) for our clients, where our focus is on methods like appearance, pH, color, clarity, sub-visible particle testing and break loose gliding force.

Primary Responsibilities

• Author and review transfer, qualification and validation protocols, reports and SOPs
• Data analysis and data evaluation as well as method trouble shooting
• Handing over transferred and validated methods to our QC testing teams
• Analytical method support to the QC testing teams, including OOS investigational support as a subject matter expert
• Change control assessment of for example method changes or specification changes
• Support validation and implementation of new instruments in collaboration with the QC Instrument Supporting team
• Ensure compliance with cGMP and participate in audits and inspections as needed

Qualifications

• A MSc or PhD degree within Pharmaceutical Sciences, Biochemistry, Biotechnology, or other relevant fields, combined with at least 5 years of work experience from the pharmaceutical or biotech industry, preferably in a QC environment
• Solid understanding of GXP guidelines, and familiar with the United States Pharmacopoeia, the European Pharmacopoeia and ICH guidelines
• Broad analytical background and experience with several of the above-mentioned methods, as well as knowledge of using JMP® or other statistical software
• Experience with method transfers and validations is a clear advantage
• Proficiency in both written and spoken English

The QC Analytical Development department Our Quality Control (QC) department at site Hillerød consists of approximately 260 employees divided into Analytical Development (AD), different support teams, and several testing teams. The QC Analytical Development department is divided into 4 teams – 2 Chemistry teams, a Bioassay team and a Project Manager team. You will be part of one of the Chemistry teams which consists of 11 scientists. The primary focus of the team is to ensure timely transfer and implementation of new analytical test methods from our customers, to be used for release testing. You will interact with many different stakeholders – both internally from QC testing teams and DS / DP production, as well as external stakeholders such as contract laboratory organizations. Furthermore, you will also work closely together with your colleagues in the team – chemists as well as laboratory technicians, so good communication and collaborative skills are a necessity. In QC we strive towards a OneQC team spirit where we help and support each other across teams. The pillar 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.

What we offer

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 and possibility to work from home. 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.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth. We also offer access to fitness and an attractive canteen.

FUJIFILM 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. Throughout the entire product life-cycle we enable success for our customers.

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 Biotechnologies Denmark 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 identity, or any other protected class.

We are part of the Fujifilm Group, and we all share the same purpose. Giving our world more smiles. We bring diverse ideas, unique capabilities, and extraordinary people together to change the world. FUJIFILM Biotechnologies works in strategic collaboration with biopharmaceutical and biotech companies to develop and manufacture the latest in biologics, advanced therapies and vaccines. With production facilities in the US and Europe, we give our customers everything they need to develop and commercialize treatments and therapies effectively and efficiently to make patients’ lives better. We are driven to revolutionize the industry through our Partners for Life mindset, seeking to build global partnerships based on trust with our customers. Our global teams fully embrace our aspiration of being the leading and most trusted Partners for Life in the biopharmaceutical industry.