Senior Project Manager, Technical Operations
Pionyr Immunotherapeutics, Inc., a growing well-funded South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced and motivated Senior Project Manager to support our CMC activities. Reporting to the SVP, Technical Operations, the Sr. CMC Project Manager will be responsible for partnering with development team members to develop, update and optimize CMC project plans as well as support clinical supply activities.
- Coordinate the design and execution of cross-functional CMC project plans.
- Maintain frequent communication with the cross-functional CMC project team members and key internal stakeholders so that all parties are aware of current project status, issues, contingencies, and milestones.
- Proactively identify CMC critical path, risks and impediments to successful development and drives the identification and development of solutions to mitigate these risks.
- Prepare summary information on CMC project progress, timeline updates and risk assessment for integration into development project team and overall program timelines.
- With team members and in accordance with corporate objectives, facilitate the setting of program CMC strategy and objectives, key milestones and scope.
- Lead CMC team organizational meetings and ensures clear agendas are set, actions and decisions are documented and communicated to meet CMC project timelines.
- Build strong working relationships across departments and with key stakeholders to ensure transparency and to facilitate communication.
- Serve as the primary point of contact for CMC project management activities internally and externally with outsourced operations.
- Assess CMC project performance using appropriate tools and techniques and identifies/quantifies any variances to the approved CMC project plan.
- BS or BA in life sciences, chemistry, engineering or equivalent; an advanced degree is a plus.
- Minimum of 7 years of experience in the biopharmaceutical industry including CMC project management experience.
- Demonstrated experience with CMC operational efforts on biologic products.
- Technical experience in CMC development of a biologic product is highly desired.
- Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment.
- Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives.
- Ability to distill, organize, and effectively communicate (verbal and written) key messages from complex discussions.
- Self-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environments.
- Demonstrated track record providing strategic and tactical support within a company.
- Diplomatic and calm under pressure; able to deal with uncertainty in a constructive manner and generate options for moving forward.
- Demonstrated ability to utilize project management tools successfully; strong computer skills and experience with software such as MS Project, SmartSheets, OnePager Pro, Excel and SharePoint.
- Solid understanding of cGMP, US and EU regulations.
- Experience working with CMC teams and managing relationships with CMOs/CROs is preferred.
- In-depth knowledge of some aspects of the biopharmaceutical industry, drug development (ex. cell line development, process/analytical development, manufacturing, drug substance/drug product, formulation and regulatory approval process) is a significant plus.
- Early-stage clinical development and IND experience is preferred; late stage development and commercial readiness is a plus.
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.