Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.
Vir Biotechnology is seeking an experienced team leader/project manager to plan, manage and drive cross-functional CMC activities associated with early development assets. In addition, this individual will help develop and drive continuous improvement to CMC business processes in all areas. Other responsibilities may include support of budgeting, and operational excellence projects. This newly-created position will report to the Sr. Director of CMC Strategic Operations.
- Creates and drives execution of high quality, integrated, cross-functional project plans that are aligned with the overall program strategy, including integration of partner / vendor activities.
- Be accountable for developing and executing on integrated product development plans in collaboration with cross-functional stakeholders. Ensure accurate forecasting, tracking and budget alignment with Program Team goals as part of the planning process.
- Represent CMC at Program Team meetings; ensure CMC timelines and strategies are aligned with overall Program Team.
- Facilitates robust communication, both within CMC department and with other key stakeholders, to ensure all functions are aware of changes in strategy and impacts to risks and resources.
- Provides standard project management support including: administrative functions, meeting facilitation, work planning and scheduling, communications preparation and distribution, and supports specific team member activities as requested.
- Creates and maintains program documentation including: agenda, minutes, action items, dashboards, goals and milestones, risk register, mitigation plan, decision log, resource tracker, timeline, internal website, etc.
- Performs critical path analysis and supports scenario planning for CMC deliverables.
- Standardizes reporting of data inputs into the portfolio in a consistent fashion across all supported CMC teams.
- Plans and tracks program and functional resources and costs.
- Actively participates and may lead the implementation of new processes and systems designed to improve the efficiency and effectiveness of the CMC Portfolio and Project Management function.
- Working with the Sr. Director of CMC Strategic Operations, develop annual budgets for the CMC department, including identification of required resources to successfully execute all departmental and program team goals.
QUALIFICATIONS AND EXPERIENCE
- Exceptional project management skills, specifically timeline and budget development and oversight with experience at all phases of the product lifecycle. Experience managing a portfolio of multiple products, and prioritization of activities and resources.
- Demonstrated competency and hands-on experience with typical CMC activities. Understanding of cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.
- Experience leading a team in a cross-functional environment, preferably with global scope
- Excellent skills with Microsoft Word, Excel, PowerPoint, and MS Project.
- Strong skills in communication, meeting management, and verbal, written, and presentation skills.
- Ability to drive problem solving, decision making, and issue resolution.
- Able to deal with uncertainty in a constructive manner and generate options for moving forward.
- Applies technical expertise in project management and contributes to the development of new concepts, techniques and standards.
- Experience managing projects with remote teams and through external alliances preferred.
- B.S. or M.S. in Biotech, Chemical Engineering, Biology, or Chemistry; additional/postgraduate qualifications (PhD, MBA, PMP, PMI) will be a distinct advantage.
- 10 – 15 years of experience in CMC development, CMC Regulatory Affairs, Quality, or Biotech Operations within the pharmaceutical or biotech industries, with at least 8 years project or program management experience.
VIR is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
The Human Resources team manages the recruitment and employment process for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.