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Senior Scientist, QC

  • Anywhere

Company :
Ascendis Pharma

Location :
Redwood City, California

Expiry Date :
Sun, 13 Jun 2021 23:59:59 GMT

Apply Job :
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Description :
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 QC to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!

The Senior Scientist will be responsible for managing a wide variety of QC and analytical development activities to support Ascendis Pharmas growing pipeline of pre-clinical and clinical programs. The Senior Scientist will work as a part of cross-functional teams across discovery and development to quickly advance new drug candidates to the clinic. The successful candidate will work closely with global Ascendis Pharma sites and CMOs/CROs to implement and improve analytical methods and will oversee external QC testing and release activities, including method validation/qualification and data review. In addition, the Senior Scientist will play a key role in developing control systems for complex drug products. The Senior Scientist will also work closely with analytical development and formulation development personnel to establish robust work processes, procedures, and documentation at the Ascendis Pharma Redwood City R&D laboratory. This is an exciting opportunity to join a growing organization, find creative solutions to problems, and have broad impact across product development.

Key Responsibilities

* Oversee analytical method transfer and phase-appropriate validation at CMOs/CROs
* Work closely with Ascendis Pharma Quality Assurance to review qualification/validation, in-process, release, and stability data packages from CMOs/CROs
* Collaborate with Ascendis and CMO analytical development staff to create and optimize QC analytical methods to support GMP manufacturing and non-GMP product development activities
* Coordinate GMP testing, release, and stability activities with external and internal quality groups, as well as establish reference standards
* Manage quality events with impact across product development functions
* Lead development of business processes and systems to ensure robust data documentation and accessibility across internal and external projects
* Develop analytical control strategies
* Author technical reports as part of method development, transfer, stability studies, etc.
* Contribute to authoring CMC-related IND sections
* Work with global teams

* Create standard procedures for equipment and processes of new laboratory

* Other responsibilities as required according to Corporate strategy or group needs
* Ability to travel domestically and internationally up to 10%

Requirements

* Preferred: a degree in chemistry or related life sciences, physical sciences, or engineering field, and 6+ yrs experience in industry with substantial experience working in a GMP/quality environment.

* Expertise overseeing and executing method validations
* Expertise in executing quality operations such as change controls, deviations, investigations
* Expertise with standard small molecule and/or polymer analytical techniques such as HPLC/UPLC, Karl Fischer, UV/Vis, IR, pH, etc.
* Expertise designing analytical control systems for small molecule pharmaceutical intermediates, drug substances, and drug products. Similar experience with polymer-based conjugates a plus.
* Passion for designing useful and effective work processes to enable robust and accessible organization of data for a wide variety of end users
* Experience authoring regulatory submission documents (e.g. relevant CMC sections of INDs, NDAs, BLAs, etc.)
* Good familiarity with relevant ICH and FDA guidelines for analytical development
* Strong communication skills and comfort working across global boundaries

* Creative problem solver generating solutions from knowledge across disciplines
* Ability to plan and conduct work with limited guidance. Clear communication, especially across global boundaries, is a key required skill.

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).