Associate Director, Pharmaceutics
Pharmaceutics | Mountain View, CA | Full Time
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
The Associate Director, Pharmaceutics is a self-motivated and creative individual who works as a member of an integrated team developing novel medicines leading to transformational therapeutics. This individual can work both independently and lead a formulation team to perform investigation and research to resolve pharmaceutical issues. This individual is capable of developing formulations for both pre-clinical studies and clinical human dosage forms. This person is able to perform characterization assays to understand the physicochemical properties of small molecule drug candidates, and to create stable and bioavailable formulations suitable for animal pharmacology, IND-enabling GLP toxicity, and different phases of clinical human studies. This individual will collaborate with and have supports from scientists from various disciplines in the both research and development divisions, including discovery chemistry, DMPK, in vivo and in vitro pharmacology and technical operations. Additionally, this individual is expected to have excellent analytical chemistry skills essential for formulation development.
The Associate Director, Pharmaceutics will be expected to lead by example and interact collaboratively with colleagues across Research and Clinical Development to inform a balanced risk/benefit profile for all drug candidates. This person actively seeks feedback, adapts quickly to emerging information, looks for opportunity to make an impact, and has a philosophy of perpetual improvement.
Essential Duties and Responsibilities
- Collaborate with drug discovery scientists to advance programs from SAR stage, lead identification and optimization, and through candidate nomination
- Manage and complete physio-chemical characterization studies for small molecule drug candidates (pharmaceutics, polymorph screening, and salt selection, etc.)
- Design and perform different pre-formulation and formulation studies to identify formulations for PK/PD, animal pharmacology, preclinical dose-ranging finding and IND-Enabling toxicology studies
- Provide expertise and help to the Pharmaceutical Development team and CROs for clinical human formulation development projects
- Independently interpret data, draw conclusions, and present results to multidisciplinary project teams
- Work with scientists in vivarium, DMPK and discovery chemistry to manage and plan the routine in vivo rat and mouse PK studies, as well as other in vivo animal PK studies in larger non-rodent species
- Assist Pharmaceutical Development and Analytical team to transfer formulations and analytical methods to CROs for clinical human formulation development
- Responsible for reports capturing formulation development activities. Ensure reports are completed timely and distributed to relevant individuals for review and approval
- Research novel formulation and process analytical technologies from literatures and scientific conference; if appropriate, introduce new technologies to ChemoCentryx to improve oral exposure of small molecule drug candidates
- Support Chemocentryx on IP filings
- Manage and maintain the formulation laboratory in good working and clean condition. Plan and acquire capital equipment and daily consumable items
- Lead and nurture junior level formulation scientist
- Ph.D. in chemistry, pharmaceutical sciences, or other related fields
- 12+ years experience working as a formulation scientist in the pharmaceutical industry
- Deep understanding of physio-chemical properties and pre-formulation characteristics of small molecule drug candidates
- Broad knowledge of and experience with different formulation types (solutions, suspensions, capsules, tablets, etc) and excipients for different delivery routes (PO, IV, IP, SC, topical, osmotic pumps, etc) in animal species and in humans
- Broad knowledge and operating skills with micronization, spray drying, nano-milling, hot melt extrusion, etc.
- Experience with solid-state characterization techniques, including DSC. TGA, XRPD, SEM, DVS and particle size distribution analysis
- Experience with solubility and dissolution rate assessments
- Experience with cGMP guidelines and GLP laboratory requirements
- Familiarity with developing chromatographic methods (especially normal and reverse phase HPLC methods) for the analysis and characterization of small molecule samples
- Science driven and detail oriented problem solver
- Flexible and adaptive team player with excellent verbal and written communication skills
- Ability to interact and connect with all levels and functional areas of the organization