Subject Matter Expert (SME), Analytical Development
Are you ready to uplevel your career? Join an innovative biopharmaceutical company and be part of our exciting journey!
We are looking for a Subject Matter Expert, Analytical Development to join our CMC Development 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 New York City (US), 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 an experienced Subject Matter Expert on Analytical Development to support the coordination of development activities within drug product formulation, assay development, control strategies, and quality control using external vendors (CRO’s). Furthermore, writing and reviewing the technical content of regulatory documents for submissions. You will also be involved in the outsourcing process, from quotations and contract negotiations to follow-up and troubleshooting with CMC partners.
Key Responsibilities
- Technical and logistical support for the development of analytical tests to support characterization, release and stability testing of DS and DP
- Identifying suitable analytical suppliers
- Coordination of outsourced analytical activities
- Interpretation and troubleshooting of analytical data
- Support in identification of critical quality attributes for each product
- Partake in creation and maintenance of release and shelf-life specifications
- Support regulatory filings in respect to sections relating to analytical testing
- Input in Product Quality Review/Annual Product Review
- Review of deviations and quality investigations from CMOs, CTLs and transporters
- Initiation of change controls
Key Qualifications
- Cand Scient. or PhD in Biochemistry, Pharmacy or similar with specific experience with analytical development, qualification and validation within the biopharmaceutical area.
- Proven experience with:
- Protein characterization and comparison studies
- Analytical development leading up to first regulatory submission for biopharmaceuticals
- Preparation of IND/IMPD for biopharmaceuticals
- Set-up and maintains stability studies for drug substance and drug product – including in-use stability
- Biological assays
- Standard protein ID, potency and purity assays
- Knowledge to standard microbial assay for sterile pharmaceutical products
- Initiate and control activities at external service providers (CDMOs)
- Skills:
- Protein chemistry
- Analytical science within the biopharmaceuticals area
- Regulatory requirement for biopharmaceuticals
- Stability programs
This is an onsite or hybrid role, and the successful candidate must be able to commute to our office in Hørsholm (Copenhagen), Denmark.
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!
Equal Employment Opportunity Statement
It is the policy of Y-mAbs to provide employment, training, compensation, promotion and other conditions of employment without regard to a person’s sex/gender, pregnancy (including childbirth, breastfeeding and related medical conditions), age, race, color, religion, creed, sexual orientation, gender identity, gender expression, genetic information, marital status, familial status, civil union or domestic partner status, nationality or national origin, ancestry, citizenship, immigrant status, military status, veteran status, handicap, physical or mental disability, use of a trained service animal, medical condition, atypical hereditary cellular or blood trait, victim of domestic violence crime, sexual assault or stalking or membership in any “protected group” under federal, state or local law. This policy applies to all conditions of employment including but not limited to recruitment, selection, placement, transfer, promotion, training, compensation, benefits and termination.
