Director, Drug Product

Nuvation Bio•Remote - Any State US, NY

1d•Hybrid

About The Position

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. 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.

Requirements

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.
Demonstrated alignment with Nuvation Bio’s values and culture.
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.
Significant Contacts: Internal employees, including executive team members. Contract Research and Manufacturing Organizations (CRMOs), site team members, and consultants.
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence , curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

Nice To Haves

Office environment with domestic travel required (depends).
Virtual/remote office (working from home).

Responsibilities

Responsible for all drug product activities from preclinical development through all clinical phases to product regulatory filing, commercialization, and life cycle management if required.
The activities involve active third-party vendor management under aggressive business timelines to achieve project deliverables.
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.
Formulations may include but are not limited to capsule, tablet, injectable, etc.
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 and manage relationships with cross functional representatives, strategic alliance partners, vendors and collaborators.
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.
Work closely with colleagues and external CRMO collaborators to rapidly advance programs to key decision points, in preparation of regulatory submission, approval and post-approval commitments.
Provide critical, detailed review of external CRMO documents including supporting excipient information, drug product paperwork, equipment information, developmental reports, etc.
Involves significant involvement with external sites on a routine basis.
Support CMC development strategies to ensure that project development timelines are in place and aligned with the project's overall company objectives.
Involves key proactive participation in external partner meetings (technical and as well business related) and may involve site visits (travel).
Oversight of Nuvation Bio activities at multiple vendors, including telecommunication and on-site visits, if necessary