What are the responsibilities and job description for the Associate Director / Director, Drug Substance CMC position at Nura Bio?
Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio’s research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system.
The Associate Director/ Director, Drug Substance CMC will report directly to the VP and Head of CMC and Supply Chain. They will oversee and be responsible for all aspects of small-molecule drug substance development and manufacturing, including process research & development, scale-up, technology transfer, process qualification/validation, and authoring of CMC dossiers and other regulatory submissions. Effective management of CROs and CDMOs in a virtual development environment will be a crucial skill and capability required to accomplish the functions mentioned. Education, skills, and experience relevant to the development of small-molecule New Chemical Entities (NCEs) will be essential.
Nura Bio offers a comprehensive generous medical and dental insurance, vision, life and disability insurance, health savings account, flexible savings, and dependent care, 401(k) plan, and highly attractive stock options.
Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!
Please send your CV with a cover letter delineating why you are interested to joinus@nurabio.com
What You Will Do:
- Ensures all development activities related to small-molecule drug substances are aligned with Company's project goals, budgets, and timelines for all stages of development.
- Works collaboratively with internal stakeholder functions such as Operations, Non-Clinical, Supply Chain, Quality, and Regulatory to meet program goals.
- Coordinates with drug product functions and clinical supply chain management to ensure accurate forecasting and timely supply of drug substance. Assists commercial forecasting.
- Provide technical leadership over all small-molecule regulatory starting material and drug substance development related activities internally and at external CDMO vendors, including oversight of route scouting, scale-up and process research development (PRD), and nGMP & GMP manufacturing.
- Identifies, evaluates, and selects appropriate external partners and CRO/CDMOs. Participates in technical audits during vendor selection.
- Prepare and manage budgets, prepare RFPs, review & approve work orders, and liaise with legal & Quality departments for MSA & QTA agreements.
- Drafts, reviews, and approves drug substance related technical documents, including process research & development reports, master batch record documentation, campaign reports, and change controls. Oversee reviews of executed batch record documentation and provides technical input toward batch release. Drives resolution of deviation & event investigations.
- Takes an active role and applies subject matter expertise to establish phase-appropriate release & shelf-life specifications in collaboration with CMC colleagues. Takes an owner/customer focused attitude to analytical development/validation and stability study data.
- Implements Quality by Design (QbD) and applies risk-based principles to establish the Quality Target Product Profile and required Critical Quality Attributes & Critical Material Attributes, including technical & quality risk assessments, design of experiments, identification of Critical Process Parameters, and implementation of appropriate manufacturing control strategies.
- Ensures that all work is conducted in accordance with applicable policies and procedures, CGMP, and regulatory standards & guidelines. Maintains an excellent understanding of global laws & regulations applicable to the pharmaceutical industry.
- Prepares internal pharmaceutical development reports and other technical documentation required for regulatory submissions including authoring, review, and approval of the requisite CMC dossiers for IND, IMPD, NDA, MAA, or other filings. Prepares drug substance related responses to health authority questions.
- Leads and participates in initiatives for improving functional processes and technical operations within CMC. Works with QA to develop appropriate SOPs.
- Assist senior management and participate in due diligence for potential business development efforts with external parties.
- Functions as person-in-plant as needed during manufacturing campaigns.
What You Will Bring:
- PhD in Advanced Synthetic Organic Chemistry with 10 years of drug substance process research & development (PRD), manufacturing, and technology transfer experience in the pharmaceutical industry.
- Substantial majority of this relevant experience gained in development of small-molecule drugs and New Chemical Entities (NCEs).
- Majority experience acquired working in innovator/sponsor companies operating in a virtual CMC and pharmaceutical development environment, overseeing external CRO/CDMO vendors.
- Substantial experience supporting late-stage development (Phase 3/registration), including oversight of commercial tech transfer and process performance qualification/validation (PPQ/PV).
- Demonstrable experience as a primary and accountable SME author for drug substance Module 3/CMC dossier content for IND/IMPD/NDAs.
- Excellent working knowledge of CGMPs, regulatory guidance, and compendial requirements, including those of FDA, EMA, ICH, and USP-NF/EP/JP.
Additional Eligibility Qualifications/Competencies
- Driven self-starter. Shows initiative and seeks out & defines required program and job objectives.
- Team oriented. Able to work collaboratively with internal colleagues & external vendors.
- Must be flexible and able to prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks and uncertainty. Exceptional problem-solving skills.
- Superb technical writing, oral, presentation, and interpersonal communication skills.
- Excellent data presentation & analysis skills, including creation of publication quality tables & graphs.
- Fluent power user in the Microsoft ecosystem, including Word and Excel, and PDF publication & editing software such as Adobe Acrobat. Comfortable with electronic records & digital workflows.
- Fastidiously detail-oriented and organized. Impeccable attention to data QC.
- Understands and anticipates the impact of business and commercial needs on advanced-stage drug development. Distinguishes research from development.
- A desire to be part of a highly innovative company aimed at helping patients with serious diseases.