Senior Formulation Scientist I / II (Contractor), Pharmaceutical Development - CMC
Company: Planet Pharma
Location: Redwood City
Posted on: May 3, 2021
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
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
- 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
- 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
- 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
- Ability to multi-task and thrive in a fast-paced innovative
Keywords: Planet Pharma, Redwood City , Senior Formulation Scientist I / II (Contractor), Pharmaceutical Development - CMC, Other , Redwood City, California
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