Senior QC Scientist

2 months ago

København, Denmark H. Lundbeck AS Full time

Senior Quality Control Scientist, QC CMC Biologics

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 Senior Quality Control Scientist

Your new role – why is this a great opportunity?
As our Senior Quality Control Scientist, you will be:

  1. Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products
  2. 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.
  3. Reviewing and approving protocols, reports, and other documents for studies performed internally and at contract laboratories
  4. Collaborating within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs
  5. 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 has employees based in both Copenhagen and Seattle; this is also the case for your new department, 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, Parkinson’s, and neurohormonal dysfunctions. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbeck’s Biologics candidates and are working in global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.

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 Senior Quality Control Scientist with minimum 5 years of experience in the biotech or pharmaceutical industry. You have an accredited bachelor’s degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal. In addition, you bring:

  1. Experience in drug-device combination products
  2. Good understanding of GDP/GMP guidelines
  3. Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia
  4. Understanding of methods used to test biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA)
  5. 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 changing 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, passionate colleagues and a culture characterized as collaborative – a must to bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Apply now
Can you see yourself as our new Senior Quality Control Scientist? 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.

If you have questions or want to hear more, please feel free to contact Trine Christensen, Senior Manager Quality Control by email Applications must be received by 09 August 2024, and they will be reviewed on an on-going basis.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve.

#J-18808-Ljbffr

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