What You Will Achieve
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 for a variety of modalities across our internal portfolio, and potentially with external partners. You will serve as the single point-of-contact for BRD on multiple early and late-stage project teams (Pharmaceutical Sciences Project Teams (PSPT) and Co-Development Teams (CDT)). You will lead the respective BRD project teams and DS subteams associated with these programs. These 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 (DS) supplies, and regulatory filings. The BRD Rep/DS Subteam lead 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 develop a comprehensive integrated project plan, as well as forecast and plan BRD 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/DS Subteam Lead you will also support the entire 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, creation of standard project plans and resource guidance. You will identify needs for enhanced operational efficiency and work to establish and implement impactful work process improvements in collaboration with stakeholders. This role will also have opportunities to contribute to business development activities including in-licensing and out-licensing activities.
It is your commitment to portfolio progression that will help in making Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
- Represent BRD on Pharm Sci Project Team (PSPT) and CoDev teams, ensuring optimal coordination of activities and deliverables, and timely communication of progress, issues, and strategies.
- Work with BRD Project Team and PharmSci teams to develop integrated project plans to support delivery of portfolio project objectives, including technology strategy, issue mitigation strategies, timelines, budget forecasts and FTE resources estimates.
- Coordinate DS deliverables with CDMOs and other external partners, representing BRD for DS-related activities and strategies.
- Establish and ensure alignment of project strategy amongst all stakeholders, including BRD S&T lines, BRD leadership team, PSPT and Pre-POC (Proof of Concept) 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 issue resolution 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 and pan-portfolio initiatives.
- Identify pan-portfolio improvements to portfolio progression work processes and support these and other BRD Portfolio Group initiatives (may include enhanced efficiency of portfolio progression through training and tools development, metric-based portfolio tracking, sharing of best practices, and other operational improvements).
- Mentor team members and emerging BRD reps and DS Subteam leads
- Keep current with BRD platforms for new modalities and manufacturing technologies
- Ph.D. with 4+ years of experience, Master's Degree with 8+ years of experience, or Bachelor's Degree with 11+ 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 biologics development.
- 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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.
Other Job Details
- Travel up to 10%, primarily to Pfizer sites or partner sites.
#LI-PFE Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Last Date to Apply: August 8, 2022
- Eligible for Employee Referral Bonus: YES
- Work Location Assignment:Flexible
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Research and Development