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Senior Formulation Scientist I / II (Contractor), Pharmaceutical Development - CMC

Company: Planet Pharma
Location: Redwood City
Posted on: May 3, 2021

Job Description:

Senior Formulation Scientist I / II (Contractor), Pharmaceutical Development – CMC  

 

This is a clinical stage biotech company dedicated to discovering and developing new drugs that translate frontier cancer targets through exceptional drug discovery delivering revolutionary medicines on behalf of cancer patients.  Our innovative science draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.  As a new member of the team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

 

We have an opening for a formulation Scientist position.  This position is a contract-based position and resides in Pharmaceutical Development within CMC function. Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of pipeline compound development and clinical programs.      

Responsibilities:

  • Lead and/or support activities for pharmaceutical profiling, phase appropriate formulation development, and drug product manufacturing of the new chemical entities during preclinical assessment and throughout clinical development phases.
  • Actively participate in pre-clinical team and CMC team to provide pharmaceutical development / developability input to influence lead identification and optimization.
  • Design and execute studies either in-house and/or through CROs/CDMOs to effectively screen candidates, to better understand delivery barriers of potential leads pertaining to the intended dosing route, and to enable candidate progression.
  • Be involved in identifying / selecting CDMOs and oversee the development and manufacturing activities at CDMOs.
  • Prepare, review, and/or approve study protocols, study reports, manufacturing batch records, development, campaign reports, and CMC regulatory submission document.
  • Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Analytical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.
  • Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 20%).

 

Required Experience, Skills and Education:

  • Preferably a PhD in pharmaceutical sciences, chemical engineering, physical organic chemistry or related discipline.
  • 5+ years of relevant experience in pharmaceutical development.
  • Experience in small molecule drug pre-formulation characterization, formulation and process development of oral and parenteral drug products.
  • Hands-on experiences in poorly water drug delivery technologies and enabling formulation development
  • Experience in drug delivery technologies through various dosing routes of administration is a plus.
  • Knowledge of basic analytical skills required: HPLC, UV, solid state characterization.
  • Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices
  • Working experience and knowledge of regulatory submission (IND, IMPD and / or NDA).
  • Excellent communication (both verbal and technical) and problem-solving skills. 
  • Ability to multi-task and thrive in a fast-paced innovative environment.

Keywords: Planet Pharma, Redwood City , Senior Formulation Scientist I / II (Contractor), Pharmaceutical Development - CMC, Other , Redwood City, California

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