[Hiring] Director, Drug Product @Nuvation Bio

Role Description

The Director of Drug Product is responsible for development of new molecular entities across the company portfolio from discovery through all clinical phases to product registration and commercialization, as applicable. The primary focus is on Phase 1 and Phase 2 formulation and process development. This role also serves as the liaison to bridge the findings from preclinical/discovery studies to viable clinical and commercial drug product candidates.

• Responsible for all drug product activities from preclinical development through all clinical phases to product regulatory filing, commercialization, and life cycle management if required.
• Act as a liaison to translate preclinical PK, pharmacological/toxicological drug candidate findings into appropriate clinical drug dosage forms for first in human studies and beyond.
• Identification, selection, and management of contract development research and manufacturing organizations (CRMOs) for formulation screening, formulation development/optimization, process development, scale-up, and validation.
• Oversight of GMP manufacture of drug product in support of clinical programs.
• Delivery of robust, scalable, and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical product profile.
• Projection of drug substance and drug product needs for preclinical and clinical programs, and associated budgets.
• Communicate, coordinate, and establish collaborative working relationships with internal Pre-Clinical, Clinical, Analytical, CMC, Quality (GCP/GxP), Regulatory, Project Management and consultants, as well as with external CROs/CMOs counterparts.
• Develop policies, SOPs, and systems to aid workflow within CMC/Quality.
• Author and review internal Nuvation Bio technical reports and presentations.
• Author and review CMC DP module sections of all regulatory submissions (Briefing Documents, Meeting Packages, INDs, IMPDs, NDAs, etc).
• Manage critical activities involving drug product GMP batch record review, along with supporting documentation.
• Lead pre-formulation and drug product formulation activities, including excipient compatibility, dosage form selection, etc.
• Support contractor sites with active telecon meeting updates, remote and on-site involvement pertaining to OOS/OOT, investigations/deviations, and other pertinent documentation.
• Support CMC activities associated with the company's programs.
• Provide critical, detailed review of external CRMO documents including supporting excipient information, drug product paperwork, equipment information, developmental reports, etc.
• Support CMC development strategies to ensure that project development timelines are in place and aligned with the project's overall company objectives.

Qualifications

• MS/PhD in Pharmaceutical Sciences, Chemical Engineering or closely related field preferred.
• 8+ years of related experience within a pharmaceutical or biotechnology related field.
• A commiserate combination of education and experience may be considered.
• This position requires an individual with progressive, broad experience covering preclinical through later phase development.
• Background in contract pharma is preferred.
• Comprehensive knowledge and experience in CMC functions, including drug substance, drug product, analytical, quality, and regulatory.
• Understanding of GMP practices, principles, and regulatory guidelines.
• Strong background in traditional and complex dosage forms.
• Ability to understand program details across multiple functions and programs, and to develop stage-appropriate strategy for drug product development.
• Demonstrated ability to lead and manage internal development, and manufacturing operations and influence external partners.
• Proven track record and ability to proactively manage multiple clients/vendors, including appropriate prioritization of activities and tasks.
• Demonstrated ability to bring focus and structure to problems in order to manage execution of deliverables in a timely manner.
• Strong problem-solving skills to address a broad range of topics and to be ahead of the program in terms of planning and execution.
• Excellent working knowledge of cGMP regulations required, including compendial (USP, EP, JP) and guidance documents.
• Strong team player with strong interpersonal skills and exceptional leadership ability with a proven ability of building and maintaining a core culture and team environment.
• Broad experience in the pharmaceutical industry with knowledge of drug discovery and clinical development through product registration and commercial readiness.
• Excellent verbal and written communication skills with ability to deliver highly-effective reports and presentations which demonstrate audience specific technical expertise.
• Office environment with domestic travel required (depends). Virtual/remote office (working from home).
• Demonstrated alignment with Nuvation Bio’s values and culture.

Requirements

• Oversight of Nuvation Bio activities at multiple vendors, including telecommunication and on-site visits, if necessary.
• Excellent communication and interpersonal skills.
• Leadership skills for internal and external activities.
• Must be able to write clearly and summarize information effectively.
• Must be able to present complex information to various audiences.

Benefits

• Competitive Base Salary, Bonus, and Equity Plans.
• Unlimited Vacation and 10 Sick Days Annually.
• Excellent Medical, Dental, and Vision Coverage.
• 401K with Company Matching.
• And much more!