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Director, Analytical Development and QC, Small Molecules

Formation Bio

Formation Bio

New York, NY, USA · Remote
Posted on Wednesday, January 3, 2024

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 Analytical Development and QC, you will spearhead the strategic direction and execution of analytical research and development and quality control activities for active pharmaceutical ingredients (API) and drug product (DP) at Formation Bio and our contract R&D and manufacturing partners for assets in Phase 1 to Phase 3. You will oversee all API and DP release stability testing as well as analytical regulatory documentation to support global clinical studies. Your role will be pivotal, ensuring alignment with regulatory standards and company objectives. This role requires a blend of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory background.

Responsibilities

  • Provide technical leadership and guidance across CMC development disciplines to all outsourced analytical methods and testing activities by providing clear objectives for multiple CDMO partners.
  • Oversee the establishment of testing methodology specifications, and stability programs for raw materials, intermediates, excipients, APIs and DPs including trend analysis, and retesting strategy for clinical trial materials.
  • Prepare budgets and forecast expenditures related to drug substance and drug product analytical development 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 (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).
  • Support, in collaboration with Quality Control and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners.
  • Cultivate strategic relationships with CMOs, suppliers, and consultants, providing oversight and recommendations for alliances.
  • Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones.
  • 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.
  • Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, or out-of-specification reports.
  • Work in close collaboration and support with other members of the CMC team responsible for API and DP development and support to management as necessary.
  • Work with Drug Substance and Drug product colleagues, as well as QA in the selection of CDMOs partners for all stages of development.
  • Develop strong relationships with external said partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.
  • Work with Regulatory, QA and Senior Management to ensure that all company policies are followed, and all external manufacturing activities comply with relevant regulations.
  • 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.

About You

  • A PhD in analytical chemistry or related field with at least 15 years of analytical/CMC team leadership in the CDMO, biotechnology or pharmaceutical industry.
  • Experience in Contract Research Organizations and/or contract laboratory relationship management.
  • Extensive technical expertise in analytical development and validation for API and DP, characterization, and stability of a variety of formulations including solid oral dose, dermal, and injectable.
  • Proficiency in reviewing and analyzing release and stability data for trending, shelf-life, and specification establishment. Thorough understanding of phase appropriate methods qualification and/or validation and specifications for APIs and DPs.
  • 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.
  • Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability.
  • 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.
  • Must be well organized, proactive, and detail-oriented.
  • Demonstrated leadership and management skills, with prior experience collaborating with and directing the work of others on assigned projects (including both internal teams and external collaborators) in multiple CMC programs.
  • Well versed with the latest technologies, trends and practices in analytical 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 $240,000 - $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.