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Director, Drug Product Development

Formation Bio

Formation Bio

Product
New York, NY, USA · Remote
Posted on Monday, December 11, 2023

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

As the Director of Drug Product, you will spearhead the strategic direction and execution of drug product 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. Your role will be pivotal in orchestrating the design, optimization, and validation of drug product processes while ensuring alignment with regulatory standards and company objectives. This role requires a blend of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or engineering to drive successful drug product development and manufacturing operations.

Responsibilities

  • Design and implement robust drug product development and manufacturing strategies, ensuring timely and efficient delivery. Plan for future needs while optimizing current processes.
  • Devise comprehensive plans for process development, optimization, scale-up, and validation, ensuring phase-appropriate execution at chosen service providers. Maintain a high standard of quality and compliance.
  • Prepare budgets, manage financials, and forecast expenditures related to drug product activities, including expenditures with contract manufacturing organizations (CMOs) and consultants.
  • Mentor and guide both internal and external team members, fostering talent growth while ensuring project success and desired outcomes. Evaluate performance, provide feedback, coach team members, and build effective cross-functional teams. Mentor them in all matters related to drug product development and manufacturing.
  • Define project deliverables, take ownership, and ensure accountability to internal stakeholders. Collaborate with the broader team to achieve set outcomes.
  • Author, review, and strategically contribute to regulatory filings and updates. Cultivate strategic relationships with CMOs, suppliers, and consultants, providing oversight and recommendations for alliances.
  • Author and review technical documents, staying abreast of industry trends, regulations, and best practices. Drive the adoption of innovative technologies and quality-by-design (QbD) approaches.
  • Lead cross-functional efforts to meet internal customer requirements and timelines, coordinating activities across chemistry, toxicology, analytical, clinical pharmacology, and drug product development.
  • Create new systems/SOPs/policies and work with Quality Assurance to oversee these for compliance with current GXP regulations.
  • Provide presentations and reports on progress on multi-disciplinary development teams, as necessary to the leadership team.

Relevant Experience

  • Advanced degree (Ph.D., Master’s) in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline or engineering with a minimum of 15 years’ technical and managerial experience, with 10 years in pharmaceutical/biotech industry roles.
  • Extensive formulation and process development expertise, including scale-up, and validation.
  • Experience with the development and manufacturing of topical formulations, solid oral dose and sterile products (small molecules and biologics)
  • Demonstrated experience in selecting and collaborating with domestic and international CMOs and consultants.
  • Demonstrated leadership and management skills, with prior experience managing internal resources.
  • Manufacturing experience and a good understanding of cGMP requirements
  • Proficient in writing RFPs, protocols, reports, and regulatory documents.
  • Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills.
  • Leadership qualities including emotional intelligence, strategic thinking, mentorship, and continuous improvement focus.
  • Sound knowledge of CGMP, ICH guidelines, regulatory affairs, and industry trends.
  • Understanding of drug substances, solid form science, and analytical chemistry as related to drug product development.
  • Excellent interpersonal skills, including negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
  • Excellent risk management, problem-solving and crisis management skills
  • Ability to work in cross-functional teams as related to drug development.
  • Well versed with the latest technologies, trends and practices in formulation development, manufacturing, and the outsourcing industry

Travel

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.