Senior Director, Drug Product Development

Company Overview:

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.

We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.

Vividion was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 and 2023 Top Workplaces list.

Job Summary:

The Senior Director, Drug Product Development will provide the leadership to integrate and oversee all aspects of product development functions or activities including preformulation sciences, formulation development, device development (where necessary), and packaging development. Identification and management of CMO sites for clinical manufacturing and commercial preparation activities will be a critical component of the role while ensuring an integrated vendor strategy supporting the portfolio. The successful candidate will interface closely with peer CMC functional leads in Chemical Development, Analytical Development, and Clinical Supply Chain, as well as other cross-functional departments in research and development.

Essential Duties and Responsibilities:

• Provide scientific, strategic, and hands-on leadership in all aspects of pharmaceutical drug product development including pre-formulation, formulation development, non-clinical and clinical manufacturing, and commercial readiness.
• Define phase-appropriate strategies for small molecule drug product development, nominate a drug delivery platform, and manufacture to meet preclinical, clinical, and market image development needs.
• Identify and provide a technical recommendation for selection of drug product formulation development and manufacturing vendors with required capabilities. Coordinate closely with analytical development on these decisions.
• Build relationships and lead outsourced drug product development and manufacturing activities including contracts, timelines, and budgets a to meet overall project timelines.
• Collaborate with internal and external CMC functions including project management, chemical development, analytical development, and supply chain to align priorities and project timelines. Communicate progress regularly and effectively, addressing any queries and managing any escalations.
• Maximize product development technical capability, formulation development and expertise internally and leveraging CDMO partners.
• Keep current on new technologies and identifying product IP opportunities.
• Troubleshoot formulation and manufacturing issues as needed.
• Participate in cross-functional development teams as needed; represent Drug Product Development on CMC subteams.
• Serve as CMC lead for programs in clinical development, driving the overall CMC strategy.
• Author, review and approve the relevant CMC sections for US and ex-US regulatory filings.
• Work with quality assurance (QA) to manage the release of GMP drug product and resolve technical issues or deviations.
• Review and approve master batch records, validation protocols/reports, and specifications required for drug product manufacturing, as well as author development/technical reports.

Educational and Experience Requirements:

• Ph.D. with 13+ years of experience or BS/MS with 18+ years of experience in CMC pharmaceutical sciences or closely related discipline with relevant small molecule development experience.
• Strong knowledge and implementation of ICH Guidelines and current Good Manufacturing Practices (cGMPs).
• Strong expertise in pre-formulation, API solid state properties, standard and exotic/novel excipients, and the potential impact to drug product manufacturing and performance.
• Ability to manage multiple projects spanning all phases of development and rapidly adapt to changing program needs.
• Strong track record in drug product development, CDMO management, and largescale manufacturing.
• Experience in multiple drug delivery platforms such as solid oral dosage forms, injectables and inhalation products.
• Highly experienced with FDA, EU and CMC regulatory submissions
• Excellent written and verbal communication skills.
• Ability to effectively organize and prioritize tasks to achieve deadlines.
• Evidence of ability to effectively manage and develop a high functioning team.
• Detail oriented with a talent for anticipating and mitigating risks/issues.
• Experience is clinical supply chain and drug supply forecasting a plus.

EEO & Employment Eligibility:

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Privacy Policy:

The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit https://vividion.com/publication/privacy-noticeforcalifornia-candidates/.