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 Senior Scientist Formulation Development to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!
Position Summary
The Senior Scientist will be responsible for formulation development activities to support Ascendis Pharma’s growing pipeline of sustained, localized delivery programs. The Senior Scientist will take a hands-on lead for the formulation development of injectable suspension products, including optimizing stability and robustness of drug product, drug substance, and upstream intermediates. Responsibilities of this role include conducting internal formulation and analytical activities at Ascendis Pharma’s Redwood City labs, as well as overseeing supportive activities at partner CMOs/CROs. The Senior Scientist will also serve as a leader in establishing internal laboratory capabilities in the Palo Alto area and growing the highly integrated analytical and formulation team.
Key Responsibilities
- Lead formulation development of drug product, drug product, and upstream intermediates for injectable, suspension-based localized delivery projects containing highly potent compounds, including designing and executing studies to ensure robustness
- Support development of processing steps and analytical methods to support GMP manufacturing and non-GMP activities
- Closely collaborate on analytical development activities, including implementing new analytical technologies to support formulation development
- Be a hands-on leader for laboratory activities, mentoring and training other personnel
- Clearly communicate formulation strategies and risks to technical and non-technical stakeholders
- Closely review reports and data packages from CMOs/CROs
- Author internal technical reports and components of health authority submissions
- Work with global teams
- Help create standard procedures for equipment and processes of new laboratory
- Identify need for new equipment and lead equipment purchase processes
- Other responsibilities as required according to Corporate strategy or group needs
- Ability to travel domestically and internationally up to 10%
Requirements
- Minimum of 3+ years of experience in industry with PhD in chemistry, biochemistry, chemical engineering or a related field required. Candidates with 5+ years of experience and Masters, or 7+ years experience and Bachelors degrees, will also be considered.
- Expertise designing and conducting formulation screening and formulation robustness studies for parenteral products, including use of DOE approaches
- Experience authoring regulatory submission documents (e.g. relevant CMC sections of INDs, NDAs, BLAs, etc.)
- Strong experience with relevant ICH and FDA guidelines for pharmaceutical development, as well as with QbD principles and their implementation to formulation and drug product development
- Expertise with standard small molecule analytical techniques such as HPLC/UPLC, Karl Fischer, UV/Vis, IR, pH, etc.
- Experience interpreting MS, IR, GC, NMR, DSC, light scattering, and microscopy data
- Experience with protein analytical methods a plus, including ELISA, SEC-HPLC, CE-SDS, IEF/iCIEF
- Strong ability to clearly communicate risks, progress, and strategies in written documents and oral presentations
- Excellent communication skills and comfort working across global boundaries
- Creative problem solver generating solutions from knowledge across disciplines
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable).