Nura Bio · 3 months ago
Associate Director / Director, Drug Substance CMC
South San Francisco, CA
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expNura Bio, Inc. is a clinical-stage biopharmaceutical company developing neuroprotective therapies for neurological diseases. The Associate Director/Director, Drug Substance CMC will oversee all aspects of small-molecule drug substance development and manufacturing, ensuring alignment with project goals and regulatory compliance.
BiotechnologyHealth CareMedicalNeuroscienceWellness
Responsibilities
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
Qualification
Required
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
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
Benefits
Comprehensive generous medical and dental insurance
Vision, life and disability insurance
Health savings account
Flexible savings
Dependent care
401(k) plan
Highly attractive stock options
Company
Nura Bio
Nura Bio is a clinical-stage biopharmaceutical company focused on developing neuroprotective therapies to treat neurological diseases.
11-50 employees
H1B Sponsorship
Nura Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (2)
Funding
Current Stage
Early StageTotal Funding
$141MKey Investors
The Column Group
2024-09-17Series A· $68M
2020-07-29Series A· $73M
Leadership Team
Bryan Miller
Interim CFO
Maria Brar
Senior Executive Assistant to the CEO | Office Manager
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-10-01
Pharma Letter
2025-02-19
Google Patent
2025-02-08
Company data provided by crunchbase