Specialist, QC CMC Biologics
H. Lundbeck A/S
Do you want to join our international CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Specialist!
Your new role
As our Specialist, you will be:
- Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products
- Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, e.g., sampling plans, Certificate of Analysis, stability studies, method validation etc.
- Reviewing and approving protocols, reports, and other documents for studies performed internally and at contract laboratories
- Collaborating within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs
- Supporting regulatory filings and other interactions with Health Authorities
This position is a great opportunity where you will be part of a team ensuring the quality of Lundbeck’s development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team. Some travelling, on average 2-4 trips per year, is estimated in this role.
Your future team
In CMC Biologics, we are more than 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA. Most of the teams in the CMC Biologics organization have employees based in both Copenhagen and Seattle; this is also the case for your new team, Quality Control. You will work out of the headquarter in Valby, Copenhagen, and will report to the Senior Manager Quality Control, in Valby. Your colleagues in the Quality Control team are all experienced specialists, and together we are responsible for the quality of Cell Banks, Drug Substance, and Drug Product for all Lundbeck development biological projects.
CMC Biologics support the development and production of new biologics drug candidates for diseases like Migraine, Multiple System Atrophy, and neurohormonal dysfunctions. Established CMC Biologics focus team and task force teams are responsible for the continued development of Lundbeck’s Biologics candidates and are working in project teams with representatives from Manufacturing Science (upstream and downstream), Drug Product Technology including device and combination products, Regulatory Affairs, and Quality Control.
As our team is located both in Copenhagen and Seattle, it is necessary to accommodate to the time zone difference for meetings. We aim to reduce late meetings to a minimum by maintaining a primary meeting band in the calendar and by applying a geographical proximity, when working with our global CMOs.
The position is based in Valby, Copenhagen - Denmark.
What you bring to the team
You are a highly skilled Specialist with minimum 7 years of experience in the biotech or pharmaceutical industry. You have an accredited MSc or PhD in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal. In addition, you bring:
- Experience in drug-device combination products
- Good understanding of GDP/GMP guidelines
- Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia
- Understanding of methods used to test biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA)
- Advanced English verbal and written communication skills
As a person, you enjoy working in cross-functional teams and have the ability to work effectively in matrix teams in a fast-paced environment with evolving priorities. You have effective verbal communication and collaboration skills, along with good written communication skills and the ability to summarize scientific data in an organized, clear, and persuasive manner. In addition, you bring a quality mindset, and you are motivated by teamwork, openness, continuous improvement, and career development. Candidates fulfilling most but not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications.
Our promise to you
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion
.
Apply now
Can you see yourself as our new Specialist? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.
Applications must be received by 22 April 2025, and they will be reviewed on an on-going basis.
Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).
#EveryBrainInTheGame
This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
Opslaget er indhentet automatisk fra virksomhedens jobsider og vises derfor kun som uddrag. Log ind for at se det fulde opslag eller gå videre til opslaget her:
