QC Scientist - Maternity Cover

FUJIFILM Biotechnologies; Hillerød; Sur place; DKK 800 000 - 1 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Massage and physiotherapy

Health check

Fitness center

Work from home

Canteen and Friday brunch

Résumé du poste

FUJIFILM Biotechnologies Denmark in Hillerød is seeking a scientist for the QC Analytical Development team to lead the implementation and transfer of analytical methods in support of tech transfer and release. You will author and review protocols, validate methods, and support audits.

Candidates hold MSc or PhD in Pharmaceutical Sciences with 5+ years in pharma/biotech, strong GMP knowledge, experience with JMP and method transfers, and excellent English.

Qualifications

• MSc or PhD degree within Pharmaceutical Sciences, Biochemistry, Biotechnology, or other relevant fields with at least 5 years of pharma/biotech experience, preferably QC
• Familiar with GXP guidelines, USP, EP and ICH guidelines
• Broad analytical background and experience with several analytical methods; knowledge of JMP or other statistical software
• Experience with method transfers and validations is a clear advantage
• Proficiency in written and spoken English

Responsabilités

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

Formation

MSc or PhD in Pharmaceutical Sciences

Outils

JMP

Description du poste

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

We value teamwork and a can-do attitude and are looking for a new colleague with:

• 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

You are quality focused, analytical, and pragmatic, with a structured approach that is easy to follow. You thrive in a fast-changing environment, where you juggle multiple tasks simultaneously with the ability to plan your projects and deliverables in a structured way. Collaborating across departments and projects comes naturally to you. In addition, you value knowledge sharing and communicating openly and professionally. Finally, you welcome working from home.

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. 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.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy - what we call Genki to join our team.

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 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.