Senior Scientist, Formulation Development

Location
Brisbane, California, United States
Posted
Sep 28, 2020
Ref
1713904735
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference. If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.SUMMARY: Responsible for oral dosage form development and preformulation characterization of MyoKardia's small molecule drug candidates. This individual will develop formulation strategies and timelines, provide technical leadership of formulation development and GMP manufacturing at contract manufacturing organizations (CMOs), 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:
  • Develop robust immediate/modified release solid oral dosage forms following quality by design (QbD) principles
  • Oversee contract manufacturing organizations (CMOs) for formulation and process development, scale up and GMP manufacturing activities within project timelines
  • Preformulation characterization of preclinical and clinical compounds
  • Author and review written documents including development reports, technical memos, batch records, and relevant CMC sections for various regulatory filings, etc.
  • Mentor and supervise junior technical staff
  • Serve as formulation lead in multidisciplinary project teams and/or sub-teams
  • Work effectively in a cross-functional matrix environment, with internal and external customers and proactively communicate with internal and external stakeholders.
  • Evaluate new formulation and preformulation technologies
  • Execute high quality experiments and prepare formulations for PK/PD/Tox studies as needed
  • Other duties as assigned


EDUCATION/EXPERIENCE/SKILLS:

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


Experience:
  • Ph.D. candidates with at least 6-8 years of experience or MS/BS candidates with at least 10-15 years of experience in small molecule formulation development in pharmaceutical industry
  • Experience with CMO/CRO oversight is required
  • Experience with enabling and/or parenteral formulation development and scale up production is highly desired


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
  • Ability to establish and maintain effective working relationships
  • Strong ability to trouble-shoot technical problems
  • Detail oriented, with good organizational skills and project management skills
  • Able to work in a fast paced team environment, meet deadlines, and prioritize work on multiple projects
  • Excellent oral and written communication skills