Associate Director, Drug Product and Formulation Development

Employer: BridgeBio LLC
Location: San Francisco, CA, United States
Start date: Dec 5, 2020

Discipline: Marketing, Product Development/Management, Science/R&D, Biotechnology, Pharmacology
Required Education: Masters Degree/MBA
Position Type: Full time
Hotbed: Biotech Bay

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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

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