In your role as Bioprocess Research & Development Portfolio Representative (BRD Rep) you will enable progression of clinical trials through ensuring on-time delivery of drug substance and regulatory submissions for various modalities of investigative biological products. You will serve as the single point-of-contact for BRD on multiple Pharmaceutical Sciences Project Teams (PSPT) and lead the BRD project teams associated with these programs. The BRD teams, comprised of scientists from Science & Technology (S&T) lines within BRD, are responsible for cell line and process development, ensuring manufacture of regulatory toxicology and clinical Drug Substance supplies, and regulatory filings.
The BRD Rep combines knowledge of BRD scientific disciplines and biologics development with project management skills to ensure project deliverables are met. You will provide the BRD perspective to the PSPT to develop a comprehensive project plan, as well as forecasting and planning resource requirements for your project team. You will undertake mentoring activities to guide team members, and update leadership teams and governance bodies regarding emerging issues, risk mitigation strategies and team achievements.
As BRD Rep you will also support the full portfolio through BRD-wide and PS-wide initiatives, such as design and implementation of metric-driven systems for tracking portfolio progression, training and tools for project teams, and creation of standard project plans and resource guidance. You will help identify needs for enhanced operational efficiency and work to establish and implement impactful work process improvements.
It is your commitment to portfolio progression that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
Represent BRD on Pharm Sci Project Team (PSPT), ensuring optimal coordination of activities and deliverables, and timely communication of progress, issues, and strategies.
Work with BRD Project Team and PSPT to develop integrated project plans to support delivery of portfolio project objectives, including technology strategy, issues mitigation strategies, timelines, budget forecasts and FTE resource estimates.
Establish and ensure alignment of project strategy amongst all stakeholders, including BRD S&T lines, BRD leadership team, PSPT and Pre-POC Management Team.
Identify and communicate project risks and issues. Guide BRD project team in defining risk mitigation strategies for realized and potential issues, and seek endorsement of risk mitigation strategies from appropriate stakeholders.
Work with the BRD Project team to facilitate decision making and problem solving for DS-related issues. As necessary, work with BRD line management and Subject Matter Experts (SMEs) to technically and strategically represent BRD in the PSPT and other management teams.
Coordinate authoring and review of regulatory documentation, following internal SOPs and BRD guidelines.
Successfully balance workload of multiple portfolio projects.
Support BRD Portfolio Group initiatives for enhanced efficiency of portfolio progression through training and tools development, metric-based portfolio tracking, sharing of best practices, and other operational improvements.
Maintain current knowledge of BRD platform technologies including new modalities and manufacturing technologies.
Bachelor's Degree with 5-8 years of experience or Master's Degree with 3-6 years of experience in the area of Genetics, Molecular or Cell Biology, Biochemistry, Biological Sciences/Life Sciences, or Chemical/Biochemical Engineering with experience in development of biological therapeutics and/or vaccines within the biopharmaceutical industry.
Ability to prioritize and manage multiple activities and priorities simultaneously.
Broad technical knowledge of cell line and process development of biologics achieved through industrial experience and understanding of early phase Pharmaceutical Sciences project progression.
Ability to work and communicate effectively across functional lines and organizations.
Collaborative, team oriented leadership and participation style, and ability to mentor less-experienced team members.
Strong and pragmatic technical problem solving skills.
Proven record of managing projects of moderate complexity and leading effective teams.
Demonstrated proficiency with tools used for project planning, tracking and management, including Excel, GDMS, SharePoint, etc.
Prior experience on portfolio project teams as BRD rep or BRD line technology lead.
Ability to distill information from multiple sources into a cohesive project plan, and to analyze project specific experience to translate into guidance across portfolio projects.
Familiarity with regulatory/ICH guidelines and IND/IMPD regulatory filings.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May include travel (up to 10%) primarily to other Pfizer sites.
OTHER JOB DETAILS
Work Location Assignment: Flexible
Flexible colleagues are assigned to a Pfizer site in Workday where they are expected to work onsite 2-3 days weekly.
Relocation assistance may be available based on business needs and/or eligibility.
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EEO & Employment Eligibility
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Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...