Drug Product Specialist

Drug Product Specialist - CMC Biologics

Do you want to join our international CMC Biologics Drug Product Technology 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 Drug Product Specialist!

At Lundbeck, we are one of the few pharmaceutical companies in the world focusing exclusively on brain diseases, and we are tirelessly dedicated to restoring brain health, so every person can be their best.

Our biologics pipeline is growing, and we need your competences to secure new treatments reach the patients.

Your new role – why is this a great opportunity?
As our Drug Product Specialist, you will expand our competences within Primary Packaging, Sterile Fill-Finish processes, Drug Product technology, or/and Drug Product formulation support.

You will work in close collaboration with colleagues across the organization globally, as a member in our multidisciplinary project teams and in close contact with our network of global Contract Development Manufacturing Organizations (CDMOs).

Your job and key responsibilities in CMC Biologics could involve:

• Good understanding of Good Documentation Practice (GDP) / Good Manufacturing Practice (GMP) for Sterile Fill-Finish manufacturing (Drug Product)
• Support design and development of drug product manufacturing processes according to best practice in collaboration with the CDMOs
• Supporting regulatory filings and other interactions with Health Authorities
• Subject Matter Expert (SME) for Primary Packaging Systems and biologics
• Work in close collaboration with our Formulation Development department to identify the optimal Drug Product formulation in combination with a Primary Packaging System

This position is a great development opportunity where you will be part of a growing area within Lundbeck and work with various internal and external stakeholders.

Your future team
In CMC Biologics we are more than 115 colleagues, split between Lundbeck Headquarters in Copenhagen and Lundbeck Center of Excellence (CoE) in Seattle, US. Most of the CMC Biologics organisation has employees based in both Copenhagen, Denmark and Seattle, US. This is also the case for your new department, Drug Product Technology, where the split is 80/20 between the two sites with most employees in DK. You will work out of the headquarter in Valby, Copenhagen, and will report to the Senior Director for Drug Product Development also located in Valby, DK.

Drug Product Technology is our department, and we are responsible for late-stage development of Drug Product including but not limited to identifying/selecting/implementing Primary Packaging Systems, establishing Fill-Finish process at CDMOs, plan and execute development studies/engineering runs/GMP runs/clinical productions and we have a shared responsibility for the validation of Drug Production. Commercial production is outside our department’s responsibility, but we support as needed. We do work in close collaboration with our Formulation Development department in Seattle, US.

Drug Product Technology is also responsible for Lundbeck’s efforts within devices and Combination Products. Therefore, you will also collaborate with team members focusing on Combination Products and you will potentially be part of defining the interface between Drug Product and Device as needed.

In Lundbeck, we aim to develop new innovating treatments to improve the lives of patients living with brain diseases. CMC Biologics support the development and production of new Biologics drug candidates for diseases like Migraine, Parkinson’s, and Alzheimer’s. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbeck’s Biologics candidates to successful marked launch. We are working into global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, QA, and Commercial.

Some business travels to partners in Asia, Europe and United States are to be expected. As our team is located both in Copenhagen and Seattle, we need to accommodate to time zone differences when we have meetings together. We aim to reduce late meetings by maintaining a primary meeting band in the calendar in combination with a flexible workday.

What you bring to the team
You hold a Bachelor of Science, Master of Science or PhD in engineering, chemistry, biological science or equal. In addition, you bring 3+ years of experience working with Fill-Finish production or drug product development.

Furthermore, you have some of the following skills or interested in obtaining the skills:

• Knowledge within Sterile Fill-Finish manufacturing including processes and equipment
• Experience within process designs and Quality Risk Management
• Experience within the field of formulation development and protein stability
• Knowledge of cGMP requirements, regulations, and guideline
• Knowledge within Primary Packaging Systems with focus on pre-filled syringes, vials, and stoppers
• Experience in collaborating with vendors of Primary Packaging components (e.g. BD, Ompi, West Pharma, Datwyler etc.)
• A team player with a positive attitude
• Experienced with working in an international setting with different cultures and the ability to travel

Candidates fulfilling some and not all the listed qualifications are encouraged to apply, as the position is adjusted according to qualifications and wishes for your future career.

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.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

Apply now
Can you see yourself as our new Drug Product Specialist and want to join our international team of Device and Drug Product Specialists?

Then upload your CV and include 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, please feel free to contact Michael Torben Pedersen, Senior Director of Drug Product Technology, on [email protected] or (+45) 2944 5851.

Applications must be received by August 31, 2024 and will be reviewed on an ongoing 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. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

#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
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.