Director, Drug Substance Development- Small Molecule
About Formation Bio
At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.
At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.
Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.
About the Role
The Director, Drug Substance Development, will be responsible for directing the Drug Substance process development and manufacturing activities at Formation Bio and our contract R&D and manufacturing partners for assets in Phase 1 to Phase 3, as well as registration and validation.
- Design and execute drug substance development and manufacturing strategies that deliver drug substance on-time/in-full when needed while preparing for the future.
- Devise detailed plans for drug substance process development/optimization, scale-up and validation in a phase-appropriate manner and execute them at chosen contract service providers/partners.
- Set clear outcomes/deliverables for projects with the larger TrialSpark team and own them, staying accountable to all internal stakeholders.
- Mentor direct reports and team members (internal as well as external) in a way that assures desired project outcomes while developing and providing opportunities for rising talent.
- Prepare budget, manage financials, and forecast drug substance expenditures (including expenditures with CMOs and consultants)
- Author, review, and provide strategic input for regulatory filings (including INDs, IMPDs, NDAs, briefing packages and other regulatory dossiers) and updates.
- Prepare for and participate in meetings with the FDA or other regulatory bodies as needed.
- Develop strategic and beneficial relationships with CMOs, RM suppliers, consultants, etc. and actively manage/oversee these external parties. Regularly evaluate and provide recommendations to senior management for changes and/or any new alliances.
- Review and approve technical documents (e.g., CGMP documentation with CMOs) in a timely manner.
- Stay current on industry trends, practices and regulatory guidance.
- Manage priorities and timelines while also creating value by devising new possibilities and practicing the best/most practical technologies, including the use of QbD and PAT where appropriate.
- Create new systems/policies with an eye on Continuous Improvement and oversee these for compliance and efficiencies.
- Evaluate and judge performance of direct reports, team members, consultants, CMOs, provide effective feedback and coaching as and when needed, and build effective teams.
- Provide direction/oversight for EHS related matters and mitigate/manage risks related to chemical process safety and occupational health handling of Drug Substances.
- When appropriate, lead cross-functional needs to meet internal customers’ requirements/ timelines including chemistry, toxicology, analytical (including stability) and drug product development, and accordingly provide appropriate support to management.
- Provide presentations and updates as necessary to the leadership team.
- Ph.D. in chemistry with at least 15 years of related technical (process chemistry, problem solving, scale-up) and management experience and 10 years work experience in the pharmaceutical/biotech industry.
- Prior experience selecting and working with domestic and international CMOs and consultants. A thorough understanding of synthetic and process chemistry and solid form science.
- Experience and working knowledge in early-phase, late phase development, and validation.
- Excellent writing skills as they relate to preparation of RFPs, protocols, and reports.
- Experience with the preparation of regulatory documents is a must.
- Excellent interpersonal skills with strong oral/written communication and presentation skills.
- Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
- Excellent problem-solving skills and analytical thinking capabilities.
- Developed leadership attributes such as a high level of emotional intelligence, strategic thinking, effective listening, and decision making, anticipation and risk management, questioning the status quo, mentorship, focus on continuous improvement, etc.
- Ability to communicate difficult concepts, ideas and solutions to senior leaders in other scientific disciplines.
- Keen level of self-awareness, a desire to learn new skills/knowledge and to effectively participate/lead cross-functional teams.
- A strong understanding of CGMP requirements and ICH and regulatory guidance.
- Familiarity of Quality and Regulatory Affairs as applicable to CMOs compliance and regulatory filings.
- Well versed with the latest trend in technologies and the outsourcing industry
Travel may be required up to 25-30% of your time.
We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $247,000 - $280,000.
On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.
If this range doesn’t match your expectations, please still apply because we may have something else for you.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.