Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to supporting your professional development on our journey.
Ascendis Pharma is looking to hire an experienced CMO Manager/Scientist, Development Chemistry to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!
We are seeking an exceptional organic chemist to join our development chemistry team and take a key role in the process chemistry and CMO management.
The ideal candidate will have a broad organic chemistry background and ability to apply modern synthetic tools in a practical setting. She/he will be responsible for executing in-house process optimization, scale-up activities as well as providing technical support for GMP manufacturing efforts at partner CMOs. This is a great opportunity to work collaboratively in a cross-functional team with Quality, Regulatory, Process and Analytical Development to support advancing Ascendis Pharma’s product candidates to clinical studies.
- Develop and optimize process chemistry to enable robust and scalable process for the manufacturing of small molecule drug substances, monomers and crosslinkers related to Ascendis’ TransCon technology
- Demonstrate and transfer processes from R&D lab to GMP manufacturing to ensure successful implementation at CMOs
- Provide technical support to CMOs on raw material and drug substance sourcing, oversee manufacturing activities to ensure timely delivery of quality products
- Work closely with cross-functional project teams and provide subject matter expertise to Quality, Regulatory, Analytical and Process Development as needed
- Author CMC sections of regulatory filings, patent applications and manuscripts as needed
- Contribute to our efforts of constantly evolving operations in our new R&D facility for technical product development with process chemistry, analytical, formulation and process development labs
- Other responsibilities as required according to Corporate strategy or group needs
- PhD in organic chemistry with 2+ years of process chemistry experience in pharmaceutical industry. B.S. or M.S. degree with proven experiences and achievement in drug development will also be considered
- Previous experience with CMO or vender management is preferred
- Proven scientific track record and creative approach to problem-solving
- Excellent laboratory and organizational skills. Ability to work effectively under tight timelines
- Good knowledge of cGMPs, ICH guidelines, regulatory and quality requirements including highly potent drugs
- Effective team player with an open mindset and excellent oral/written communication skills
- Ability to travel domestically and internationally as required
- Medical insurance
- Vision insurance
- Dental insurance
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance