Formulation Scientist Job Opening in New Haven CT (not for

d
davidbh
楼主 (未名空间)

发一个formulator的机会,PROTAC, base $120-140 + bonus, transfer H1B,
relocate
PhD, with 2+ years of experience in industrial drug development, or BS with 8+ years of experience or MS with 4+ years of experience in industrial drug development required.
有意者站内联系。必须有工业界经历,非诚勿扰。

具体JD如下:
Arvinas is a pharmaceutical company focused on developing new small
molecules ‒ known as PROTAC® (PROteolysis TArgeting Chimeras) &#
8210; aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural
protein degradation approaches into novel drugs for the treatment of cancer and other diseases. The proprietary PROTAC® -based drug paradigm
induces protein degradation, rather than protein inhibition, using the
ubiquitin proteasome system and offers the advantage of potentially
targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously
unapproachable targets. For more information, visit www.arvinas.com.

Position Summary
The Research Scientist will serve as a core member of the development team
and execute formulation strategy for Arvinas drug candidates. The incumbent will be responsible for executing exploratory research and development
studies, as well as supporting preclinical supply manufacture through in-
house experimental efforts and CDMOs. In addition, the successful candidate will support the in vivo group in preparing dosing solutions and designing
vehicles for BCS II/IV compounds. He/She will work closely with in vivo,
biology, chemistry, and when necessary, clinical groups to develop vehicles and formulation to advance assets into preclinical and early clinical
studies. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.
This position reports to the Executive Director, Formulation Research &
Development, and will be located at our headquarters in New Haven, CT.

Principal Responsibilities
Responsibilities include research on and development of formulations to
support enabling exploratory and pre-clinical animal studies, as well as
clinical studies. Most of this will be accomplished through direct
laboratory work with the opportunity to leverage out-sourced activities. In addition to a hands-on component, the incumbent will be responsible for
preparing requests-for-proposals and monitoring the activities of several
formulation development and manufacturing organizations. The incumbent will provide critical analysis of on-going development activities and
continually assess the suitability of a particular formulation for its
intended use. A key activity of this role will be the assembly/evaluation of pharmaceutical study data and assisting in its incorporation of the
relevant sections of regulatory documents, e.g. INDs and NDAs.
Key responsibilities of this role include, but are not limited to:
• Design, carry out, and interpret preformulation studies on new
and potential drug candidates, with the purpose of defining their
physicochemical and biopharmaceutical properties relevant to oral and
parenteral administration.
• Develop fit-for-purpose formulations to enable exploratory and
enabling animal studies.
• Provide technical expertise, and specialized knowledge in
formulation development and drug product manufacturing to support the
Arvinas portfolio of drug candidates.
• Work closely with in-life groups to develop and prepare
formulations suitable for use in drug discovery pharmacology,
pharmacokinetic, and toxicology studies.
• Assist in the preparation of requests-for-proposals, selection of vendors, and monitoring the activities/emergent data of/from formulation
development and manufacturing organizations.
• Apply scientifically-driven thinking to the development of
formulations and products which meet pre-determined product profiles.
• Analyze and evaluate data associated with characterization of
drug products and stability testing and assess suitability of a drug product for an intended purpose.
• Convert data on formulations/products into knowledge required for regulatory filings, e.g. IND and NDA. Assist in drafting the relevant
sections of these documents.
• Works closely with peers on project teams to seamlessly and
expeditiously advance Arvinas assets into the clinic.
• Assist in the development of clinical parenteral formulations.
• Maintain a state-of-the-art understanding of formulation/drug-
delivery technologies and how they are best applied to identification and
enablement of beyond rule-of-five compounds.

Qualifications
• Hands-on, laboratory experience with formulation development/
manufacturing of BCS II/IV compounds.
• An understanding of basic medicinal chemistry and
biopharmaceutical principles as they apply to drug discovery and development.
• A willingness to take on challenging problem statements and
acquire/apply the skills necessary to address them.
• Ability to be proactive in identifying issues and hurdles that
may hinder the effective implementation and/or progression of a study and
resolve the issues in a timely and creative fashion.
• Ability to effectively prioritize and deliver on tight timelines.• Appreciate the necessity of thinking innovatively and reduce such thinking to practical implementation enabling the discovery and development of new molecular entities.
• Experience in communicating/presenting complex information to
scientists from other disciplines.
• Ability to multi-task and manage several projects in parallel,
paying attention to detail.
• Ability to forge cross-functional working relationships with
internal and external project partners.
• Good oral and written communications skills.
• Experience in using computers and databases for data collection, compilation, analysis, and information dissemination.
• Proficient with MS Word, PowerPoint, Excel, and HPLC systems.
Education
• Degree in discipline of a Pharmaceutical Science
• PhD, with 2+ years of experience in industrial drug development, or BS with 8+ years of experience or MS with 4+ years of experience in
industrial drug development required.