Associate Director/Director Process Chemistry
Location: South San Francisco, CA
Blade Therapeutics is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.
Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. The Company has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti-fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.
Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.
Role: Associate Director/Director Process Chemistry
Reporting to the Chief Technology Officer, the Associate Director/Director, Drug Substance Process Development and Manufacturing will be responsible for managing the CDMO activities on process development and manufacturing of Blade Therapeutics portfolio compounds.
The successful candidate will have extensive experience managing contract development manufacturing organizations (CDMOs). This position will also require the preparation of key sections of regulatory documents (such as INDs and IMPDs).
- Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials (RSMs), and drug substance.
- Assist with contract negotiations and budgeting for DS related manufacturing, testing and release.
- Actively participate in the selection and evaluation of new third-party contractors and suppliers for process development and manufacturing activities.
- Manage routine CDMO project activities including co-hosting weekly t-con, reviewing weekly update, writing meeting agenda and meeting minutes, etc.
- Participate and support all quality events including discrepancy/deviation/OOS/OOT investigations.
- Contribute to Quality/CMC related regulatory correspondence and applications (IND /IMPD/MAA).
- Onsite management of key development and manufacturing events including kick-off meeting as needed.
- Establish adequate documentation processes and systems to ensure robust document review and approval on time.
- Identify and mitigate potential quality and regulatory risks for drug substance manufacturing and subsequent resolution of compliance and quality issues.
- Represent drug substance function in technical project teams as needed.
- PhD in Organic Chemistry with more than 10 years of development and manufacturing experience.
- Strong understanding of FDA/EMEA/ICH/cGMP guidance.
- Prior experience with regulatory submissions a plus.
- Demonstrated ability to effective lead projects with internal and external resources.
- Demonstrated consistent achievement of team delivery against commitments and goals.
- Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.
- Strong teamwork, negotiation and influencing skills, able to work in a team setting and establish clear and consistent goals and objectives.
- Must be hands on, detailed oriented, self-driven and goal-oriented, and able to multi-task to achieve results.
- Must be able to adhere to strict project timelines and budgets, and to helm and advise teams and management of impacts and changes in project time-lines.
- Ability to manage changing priorities, evaluate impact, and communicate timeline and resource impacts to project teams and management is required.
- “Out of the box” thinker, to take on calculated risks, and champion new ideas and approaches.
- PhD in Organic Chemistry
An attractive compensation package commensurate with this senior leadership role will be provided.