Are you ready to uplevel your career? Join an innovative biopharmaceutical company and be part of our exciting journey!
We are looking for a Product Support Manager, CMC to join our CMC Operations team.
Working with Us
At Y-mAbs Therapeutics (NASDAQ: YMAB), our mission is to become the world leader in developing better and safer radioimmunotherapy and antibody-based oncology products addressing clear unmet pediatric and adult medical needs. With the right partnerships and collaborations, we envision changing the course of cancer treatment and improving outcomes for patients and their families.
We have offices in Princeton, New Jersey (US) and Hørsholm, Denmark (near Copenhagen). We also have a laboratory based in Nutley, New Jersey (US).
Y-mAbs has an exciting future ahead. If you are passionate about being part of a truly patient-centric organization focused on developing and commercializing cutting-edge therapies to treat a variety of cancers, we want to hear from you!
About the Role
Y-mAbs seeks a highly skilled Product Support Manager, CMC to join our team and provide comprehensive scientific, technical, and regulatory support for our global commercial monoclonal antibody (mAb) product.
This role is crucial in ensuring the smooth operation of our product's lifecycle management and daily operations, with a focus on supporting our contract manufacturing organization (CMO) partners.
Key Responsibilities
- Provide scientific and technical expertise to support the CMC aspects of our commercial biotechnology product
- Collaborate with CMOs to oversee and optimize manufacturing processes, ensuring compliance with quality standards and timelines
- Develop and implement CMC strategies aligned with company goals and regulatory requirements
- Review and approve batch records, analytical data, and development reports related to CMC activities
- Contribute to the preparation of regulatory documentation, including product development reports and CMC sections for regulatory filings
- Manage and coordinate technology transfer activities with CMOs and internal teams
- Support process validation efforts and contribute to the maintenance of specifications and analytical methodologies
- Assist in defining supply strategies for drug substance and drug product required for commercial production
- Assist in interpretation, trending, and monitoring of data using statistical methods as appropriate
- Collaborate with cross-functional teams to address CMC-related issues and implement continuous improvement initiatives
Key Qualifications
- 5 years’ experience in a similar role
- Knowledge and experience working with CMOs and managing external partnerships
- GMP regulations and ICH guidelines related to biopharmaceutical manufacturing
- Good understanding of biotechnology-based drug development and manufacturing processes
- Experience with Antibody-based therapeutic products is preferred
- Regulatory affairs, particularly in preparing CMC documentation for regulatory submissions
- Lifecycle management of commercial products is highly desirable
Participation in
- CMC project meetings
- Review of key manufacturing documentation
- Review of CMC documentation
- Clinical and regulatory meetings
Location
This role is based in our Denmark office in Hørsholm, just north of Copenhagen.
Interested in Applying
If you are interested in joining Y-mAbs and becoming part of our team in a fast-moving environment that offers a unique combination of scientific insight, entrepreneurship, and exciting challenges, please apply!
