Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization.

Leading analytical method development and execution for Drug Product characterization including direct management of junior scientists. Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.

Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.

Participates as a member of the Study Management Team and acts as a safety liaison between the Drug Safety department and key stakeholders in other Iovance functional groups. Provides safety review and input into safety sections of clinical documents, including but not limited to investigational brochures, study protocols, informed consent forms, briefing documents, clinical study reports, risk management plans, product labeling, and IND/BLA packages.

Proven experience in the integration and management of PDM, and PLM systems for the product development life cycle within a manufacturing or engineering environment. , ECO process, product structure, configuration engineering, change management, and revision control and tracking.

The Product Management for Lab operations software / Lab information management system (LIMS) will be responsible for one or more components of Natera’s Laboratory Management Software product strategy and development to support laboratory operations of Natera’s tests.

4+ years of experience in product management driving projects with cross-functional colleagues. Stay ahead of the curve in the rapidly evolving wallet ecosystem, identifying and integrating cutting-edge technologies and trends to keep BitGo's wallets at the leading edge of digital asset management.

We work with companies funded by the best investors including Sequoia Capital, Lightspeed Ventures, Tiger Global Management, A16Z, Accel, DFJ, and more. You should have a strong ability to build meaningful connections with high value consumers, forge brand partnerships with sales influencers and companies on social, and create buzz on social around our product.

Job Title: VP, Product Management - Retail and CPG. Product Management Oversight: Develop comprehensive strategies for our Retail CPG products, aligning with market demands and customer needs.

Jazz Pharmaceuticals is seeking an Associate Director, Biologics Drug Product (DP) Development to join our Biologics Development team. The successful candidate will have deep understanding of liquid and lyophilized formulation development for biologics, protein degradation pathways, biophysical characterization studies, drug product process development, tech transfer, process characterization, risk assessment and implementation of control strategies.

The VP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company.

Collaborate with cross-functional departments (including Research, Pharmacology, DMPK, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance) to implement discovery & development of toxicology strategies to enable the progression of optimized drug candidates and ensure that toxicological considerations are integrated into all stages of product development.

Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, change control management, and product and compliance quality initiatives.

Represent QC in cross-functional teams (Analytical Development, QA, Manufacturing, Product Management, Supply Chain departments) to meet product release timeline and manage stability programs to ensure timely testing, real time trending and generation of stability reports.

Familiarity with product lines including Crestron, Extron, Samsung, BiAmp, Clearone, QSC / Q-SYS, D&B sound system, Shure, Yamaha CL5, Barco (E2), High End Systems, Neat, Poly, Cisco, BrightSign, etc.