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Revolution Medicines
Redwood City, CA, United States
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment
Job Source: Revolution MedicinesAdverum Biotechnologies, Inc.
Redwood City, CA, United States
Associate Director/Director, Drug Product, PD Redwood City, CA Technology Development – Technical Operations / Adverum is looking for an Associate Director / Director, Head of Drug Product Process Development (Drug Product PD) to join the Technology Development team at our Redwood City, CA office. This position is a key leadership role that focus
Job Source: Adverum Biotechnologies, Inc.Adverum Biotechnologies
Redwood City, CA, United States
Associate Director/Director, Drug Product, PD Redwood City, CA Technical Operations Full Time Adverum is looking for an Associate Director / Director, Head of Drug Product Process Development (Drug Product PD) to join the Technology Development team at our Redwood City, CA office. This position is a key leadership role that focuses on advanci
Job Source: Adverum BiotechnologiesOKXhas
San Jose, CA, United States
Who We Are At OKX, we believe the future will be reshaped by technology. Founded in 2017, we are revolutionising world systems through our cutting-edge digital asset exchange, Web3 portal and blockchain ecosystems. We reshape the financial ecosystem by offering some of the most diverse and sophisticated products, solutions, and trading tools on t
Job Source: OKXhasGabeo.ai
Palo Alto, CA, United States
**PLEASE READ: DO NOT APPLY IF YOU DON'T HAVE REVENUE CYCLE MANAGEMENT EXPERIENCE** Title: Senior Product Owner / Product Manager Director Company: Gabeo.ai Start Date: June 2024 Location: Palo Alto, California (Remote, Part-time) Compensation: Competitive Market Salary + Equity Options Gabeo.ai, a dynamic startup in the healthcare tech sector,
Job Source: Gabeo.aiWestern Digital
Milpitas, CA, United States
Salary Range: 203,150.00-287,800.00 Company Description At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible. At our core, Western Digital is a company of problem solvers. People achieve extraordinary things given the right technology. For decade
Job Source: Western DigitalOKX
San Jose, CA, United States
Who We Are At OKX, we believe the future will be reshaped by technology. Founded in 2017, we are revolutionising world systems through our cutting-edge digital asset exchange, Web3 portal and blockchain ecosystems. We reshape the financial ecosystem by offering some of the most diverse and sophisticated products, solutions, and trading tools on th
Job Source: OKXWorkato
Mountain View, CA, United States
About Workato Workato is the only integration and automation platform that is as simple as it is powerful — and because it’s built to power the largest enterprises, it is quite powerful. Simultaneously, it’s a low-code/no-code platform. This empowers any user (dev/non-dev) to painlessly automate workflows across any apps and databases. We’re pro
Job Source: WorkatoSanta Clara, CA, United States
Senior Director, Drug Product
Direct Hire Full-Time Role
Salary Range: $224,600 - $245,000 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
Playing a critical role as the drug product technical lead and CMC project lead, this position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy. You will provide technical and project leadership and work with cross-functional stakeholders to ensure pharmaceutical drug product development and CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines.
Duties and Responsibilities:
Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization
Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
Responsible for developing strategies and overseeing the execution of technical activities associated with product development and manufacturing, supporting clinical development, regulatory filings (IND/NDA/MAA), and product approvals and commercialization.
Design and oversee execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.
Author and review technical reports and CMC-related documents required for regulatory submissions.
Build and maintain a high-performing team to support the ongoing pipeline.
Strategic and technical oversight of internal staff and Contract Manufacturing Organizations (CMOs)
Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies.
Serve as a project core team member, communicate CMC strategy and project status to key stakeholders cross-functionally, and assist in driving decision-making.
Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals.
Travel to CDMOs for vendor assessment and qualification and manufacturing oversight as needed.
Requirements and Qualifications:
A PhD (minimum MSc) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.
18+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise, leadership, and early and late-phase drug product development experience with small molecules
Demonstrated strong project and cross-functional team leadership and people management skills
Leadership experience in late-stage product development, scale-up, tech transfer, and process optimization of solid oral dosage and parenteral formulations is a plus.
Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China
Exceptional problem-solving skills with strategic and sound technically driven decision-making ability
Excellent written and verbal communication skills and interpersonal skills
Innovative team player with high energy for our dynamic company environment
Desired Skills and Experience
Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application
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Email Alert for Senior Director, Drug Product jobs in Santa Clara, CA, United States
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