Associate Director, Drug Product and Formulation Development

Location
San Francisco, CA, United States
Posted
Nov 05, 2020
Ref
1462261965
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Responsibilities
  • Oversee contract development and manufacturing organizations (CDMOs) to lead the development of drug product formulations to support the program from phase I clinical through commercial launch
  • Oversight and direction of GMP production activities at contract CDMOs to support clinical trials
  • Review and approve master batch records, executed batch records, manufacturing deviations, and investigations
  • Provide on-site technical support on an as-needed basis to oversee various manufacturing/scale-up/validation activities. Provide technical expertise to troubleshoot manufacturing/packaging process issues
  • Generate and/or review experimental plans and lead drug product development activities.
  • Prepare technical reports in support of planned regulatory submissions
  • Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines
  • Assist in supply chain logistics for drug product manufacturing activities and clinical trial operations
  • Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance, Quality Assurance, Analytical Development, and Quality Control)

Education, Experience & Skills Requirements
  • Advanced degree (MS/Ph.D.) in chemistry, pharmaceutics, pharmaceutical science, chemical engineering, or other related scientific disciplines
  • 8+ years of hands-on experience with increasing responsibility in solid oral dosage manufacturing process development
  • Highly experienced in solid oral dosage form formulation development
  • Experience with the development of pediatric dosage forms
  • Experience with enabling technologies for solubility enhancement of BCS class II and IV compounds
  • A robust understanding of quality requirements for GMP drug product manufacturing. Knowledge of ICH requirements
  • Experience managing engineering challenges of large scale solid oral dosage processes involved in manufacturing, such as blending, granulation, compression, and packaging
  • Experience in writing CMC documents for regulatory submissions (IND/IMPD/NDA/MAA)
  • Strong understanding of pharmaceutical development, quality, and regulatory issues
  • Hands-on GMP experience with all phases of drug development, as well as in-depth knowledge and full understanding of GMP requirements
  • Ability to flexibly manage tasks (directly and indirectly) and variable workloads with demanding timelines
  • Ability to critically evaluate and troubleshoot complex problems while offering timely and informed options for resolution
  • Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
  • Proficiency with Microsoft software (Word/Excel/PowerPoint)
  • Position requires up to 20% travel

What We Offer
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so