Specialist/Senior Specialist – Sterile Drug Product Support and Validation, CMC Biologics

Job title:

Specialist/Senior Specialist – Sterile Drug Product Support and Validation, CMC Biologics

Company:

Lundbeck

Job description

Specialist/Senior Specialist – Sterile Drug Product Support and Validation, CMC BiologicsAre you a seasoned Process Engineer with expertise in Drug Product and/or Drug Substance Development and Manufacturing? Are you eager to join an international team of Validation Experts and work with biologics in a setting that values empowerment and cross-functional collaboration? If so, you might be the perfect fit for our Senior Drug Product Specialist role!The position level will be tailored to match the qualifications and experience of the selected candidate, ensuring transparency throughout the hiring process.Your new roleAt Lundbeck, we are among the few pharmaceutical companies globally dedicated solely to brain diseases. Our unwavering commitment is to restore brain health, enabling every individual to achieve their best.You will serve as the technical lead for process validation activities in biologics production, including Aseptic Manufacturing and Sterile Fill-Finish. Your role will involve late-stage clinical development and validations prior to commercial manufacturing. You will closely collaborate with colleagues across the organization, participate in multidisciplinary project teams, and maintain close contact with our global network of Contract Manufacturing Organizations (CMOs).Your role and key responsibilities in CMC Biologics will include:

• Acting as the technical lead and subject matter expert for Biologics Manufacturing, including Aseptic Manufacturing and Sterile Fill-Finish validation activities.
• Collaborating closely with project teams (including QA) and CMOs to plan and execute validation activities in line with regulatory requirements and company policies.
• Serving as the on-site representative at CMOs during validation activities to identify and mitigate risks, transfer technology and know-how, and address complex and critical deviations, changes, and process improvements.
• Supporting regulatory filings and other interactions with Health Authorities.
• Facilitating the internal transfer of products from CMC to Biologics Production, including drafting initial protocols for Continued Process Verifications.
• Working with DP Technology colleagues in project teams to help define the timing and content of studies for Sterile Filter Validation during clinical manufacturing.

This position offers a fantastic development opportunity, allowing you to help shape the future manufacturing strategies for biologics at Lundbeck. You will work at an exciting intersection with various internal and external stakeholders.Your future teamIn CMC Biologics, we are a team of over 100 colleagues, divided between Lundbeck Headquarters in Copenhagen and the Lundbeck Center of Excellence in Seattle. Most of our organization has employees based in both Copenhagen, Denmark, and Seattle, US. This includes your new department, Process Science & Validation, which is split close to 50/50 between the two locations. You will be based at our headquarters in Valby, Copenhagen, and report to the Director of Validation in Seattle.Your colleagues on the Validation team are all seasoned specialists in validation. Together, you will handle Drug Substance and Drug Product Validation for all Lundbeck biologics projects.At Lundbeck, our mission is to develop innovative treatments that enhance the lives of patients with brain diseases. CMC Biologics supports the development and production of new biologic drug candidates for conditions such as Migraine, Parkinson’s, and Alzheimer’s. Our dedicated CMC Biologics focus teams and working groups drive the ongoing development of Lundbeck’s biologic candidates, collaborating within global project teams that include representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.Some travel will be required for this role, though it won’t be frequent for the validation team. Since our team is based in both Copenhagen and Seattle, we need to accommodate time zone differences for our meetings. To minimize late meetings, we maintain a primary meeting window in the calendar and consider geographical proximity when working with our global CMOs.What you bring to the teamYou hold a Bachelor of Science, Master’s, or PhD in engineering, chemistry, biological sciences, or a related field. Additionally, you have over 5 years of experience in Biotechnology or Pharmaceutical Development. Ideally, you also possess more than 3 years of direct experience in Process Validation and have worked with CMOs.Additionally, you possess the following skills:

• Advanced knowledge of cGMP requirements, regulations, and guidelines.
• Fluency in English (Danish is a plus but not required).
• A team player with a positive attitude, capable of working effectively in matrix teams within a fast-paced environment with shifting priorities and high urgency.
• Strong communication and stakeholder management skills, representing the Validation team in cross-functional and cross-site teams, as well as with CMOs.
• Self-motivated, with the ability to plan and manage multiple tasks proactively.
• Experience working in an international setting with diverse cultures and the ability to travel.

Candidates who meet most, but not all, of the listed qualifications are still encouraged to apply, as the position can be adjusted accordingly.Our promise to youLundbeck 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 .Apply nowCan you see yourself in this role? 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. We ask you not to include a photo or personal information that does not relate to your professional experience.Applications must be received by 31st of January 2025.Learn more about us at , or Instagram (@h_lundbeck).#EveryBrainInTheGameThis 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.

Expected salary

Location

København

Job date

Wed, 18 Dec 2024 23:28:02 GMT

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