Senior Scientist, Formulation Development - South San Francisco, CA | Biospace
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Senior Scientist, Formulation Development

MyoKardia

Location:
South San Francisco, CA
Posted Date:
2/7/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Formulation, Senior Scientist,

Job Description


Responsible for oral dosage form development and preformulation characterization of MyoKardia’s small molecule drug candidates. This individual will develop formulation strategies, provide technical oversight of formulation development and GMP manufacturing at contract research organizations (CROs), and update multidisciplinary team with technical, timeline and budget issues. The position will be responsible for internal laboratory investigations and evaluation of new technologies that could advance MyoKardia programs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
•   Development of immediate release and modified release oral dosage forms
•   Oversight of contract manufacturing organizations (CMOs) for process development, scale up (including DOE) and GMP manufacturing activities
•   Preformulation characterization of preclinical compounds
•   Serves as formulation lead in multidisciplinary project teams and/or sub-teams
•   Preparation and/or review of written documents including technical reports, batch records, regulatory filings, etc.
•   Preparation of dose formulations for PK/PD/Tox studies as needed
•   Evaluation of new formulation and preformulation technologies
•   May supervise technical personnel

Requirements


Education:
•   Ph.D. or MS/BS in Pharmaceutical Sciences, Pharmacy, Physical Chemistry or related discipline

Experience:
•   Ph.D. candidates with 5-8 years of experience or MS/BS candidates with at least 8-10 years of experience in small molecule formulation development in pharmaceutical industry
•   Experience with CMO/CRO oversight is required
•   Experience with parenteral formulation is a plus

Knowledge/Skills/Abilities:
•   Will have expert understanding of preformulation and formulation area and uses published literature to extend understanding as well as consulting internal and external experts as needed
•   Highly independent and self-motivated and integrates well within a team
•   Strong ability to trouble-shoot technical problems
•   Good organizational skills with ability to work in a high paced team environment meet deadlines and prioritize work on multiple projects
•   Excellent oral and written communication skills