Project Manager

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Position Summary: The Project Manager is responsible for overseeing and managing a portfolio of projects, ensuring they align with the Orca Bio’s strategic goals. This role will involve project planning, risk mitigation, resource coordination, and communication with stakeholders, along with managing budgets and schedules for multiple projects at a time. This position will work cross-functionally with CMC, Science, Regulatory, Quality, and other key stakeholders as needed to set and track progress against timelines and deliverables. The successful candidate shall be an experienced project manager, with a proven track record of operating in a multidisciplinary, collaborative, fast-paced environment. The Project Manager may take on other projects as assigned.Essential Duties & ResponsibilitiesPartners with Science, CMC, Quality, Facilities, and Manufacturing, and other client stakeholders as needed to ensure projects are scoped properly, on time, and executed meticulously:Partners and reports into the PMO function to ensure alignmentCommunicates progress to senior leadership on a bi-weekly to monthly basisOwn end-to-end project delivery across internal technical teams and external client implementations: Ensure an appropriate level of urgency is communicated while maintaining focus on deliverablesIdentify potential critical issues, constraints, bottlenecks, risks, and mitigation management (and proposed solutions to support decision-making) across individual programsDrive decision making processes and escalate issues, as neededDevelop detailed project plans, timelines and resource allocationsManage meetings, including agenda preparation, meeting facilitation, documentation, and communication (e.g., distribution of minutes)Maintain project documentation, timelines and KPIsMinimum Experience and EducationEducation/Experience:Bachelor's degree in a life science or related field or equivalent experienceAdvanced scientific degree preferredPMP or other Project Management certification/training preferredMeaningful prior experience in project management required (e.g. 5 years); advanced degree may substitute for years of experienceCommunication:Persuasively convey ideas and suggestions for forward momentumSkilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategiesComfortable with negotiation and challenging the status quo and bringing forward innovative solutionsKnowledge Base:Experience in GMP Quality in the biopharmaceutical or related industryKnowledge of regulatory guidelines for drug development functions (ICH and FDA)Organizational:Strong attention to detailPropensity to document at the right levelAble to identify roadblocks and provide direction to teams to explore alternativesTechnical:Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusionsUnderstand and edit SOPsExpert with Microsoft Project (MPP) or SmartsheetWho we areWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.We maintain a start-up culture of camaraderie and leadership by example, regardless of title.We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.Notice to staffing firmsOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Salary : $125,000 - $150,000