Jennifer Silverstein Email & Phone Number

Raleigh, Nc, Us

Virum, Capital Region, Dk

Experiencing this planet's diversity of cultures, species, and landscapes is why I travel, photograph, and backpack. After 16 months of working remotely, I decided to take a sabbatical and reconnect with hobbies whose participation was limited during the pandemic, volunteer my time and skills to causes near to my heart, and renovate part of my home.

South San Francisco, California, Us

• Managed two workstreams within a drug delivery system’s development program. Co-developed the online dashboard for real-time monitoring of program milestones and the scheduling template used to capture all design control and process development activities.• Focused heavily on refining the team’s charter and communication plan to increase individual's efficiency and productive collaboration (e.g., shared understanding of scope and division of responsibilities, meeting types/frequency/attendees/notes, how to create, review, and approve jointly authored documents, standardized taxonomy of information repository).• Deployed onboarding process for new team members. Created tailored reading lists, quick reference guides for project-specific software setup and information repositories. Conducted training for all existing team members.

South San Francisco, California, Us

• Facilitated the implementation of newly published Data Integrity requirements at Technical Research & Development’s (TR&D) laboratory and manufacturing sites. • Supported a reorganization within Global Quality and Compliance group, shifting work within 5 functions to a new office location.

Irvine, Ca, Us

• Utilizing Lean principles and tools to reduce R&D group's FTE resources required to maintain compliance with the company’s Pharmaceutical Quality System (PQS). • Oversaw global, cross-functional team responsible for creating the Investigational Medicinal Product (IMP) Supply Chain Diagram process to comply with European Commission Guideline (Annex 16). Reformed existing business processes and internal IT tools, updated procedural documentation, developed and deployed training in less than a year, (for more information on complying with this regulation see the linked video).• Supported client’s revision to Quality Risk Management procedure used by early and late stage development. Incorporated new modalities and drug delivery mechanisms, ICH guidelines, and corrective actions to audit observations. Partnered with global training group to overhaul the associated web-based training’s content, incorporating more real-world scenarios and trainee interaction.

Port Washington, New York, Us

• Responsible for the growth of Western U.S. territory’s single use technology business. - Designed custom single use assemblies for downstream aseptic purification - Completed the requests for proposal and scope of work for won business- Coordinated between internal departments to ensure on time execution, reviewing output for quality conformance, and acting as the single point of contact between internal and external stakeholders

Port Washington, New York, Us

• Promoted large portfolio of life science products and services, managed San Diego County and Arizona business territories, supported global strategic account manager for multi-million dollar client, and assisted client evaluation and validation of purification technologies.

Port Washington, New York, Us

• Provided technical filter housing support to North American sales team. Increased sales by 90% in two years. - Assembled filter housing request-for-proposals for U.S. architectural and engineering firms - Co-authored new marketing brochure- Traveled with sales team to promote product line and build camaraderie

Master Of Science (M.S.), Biotechnology

Bachelor Of Science - Bs, Chemical Engineering, Economics