Gossamer Bio
Director, CMC Project Management
Gossamer Bio, San Diego, California, United States, 92189
Job SummaryThe Director, CMC Project Management will partner with the CMC Team Lead for one or more compounds, to plan and execute CMC goals supporting clinical development and commercial readiness. The candidate will also provide portfolio-level CMC project management and budget management support for the department.Essential Duties and ResponsibilitiesManage CMC project teams consisting of representatives of various CMC line functions and as required for the projects (e.g., Process Chemistry, Drug Product Development, Analytical Sciences, Clinical Supply Chain, Regulatory CMC, Quality, etc.).Facilitate team meetings, in collaboration with the CMC Team Leader, develop meeting agendas, issue meeting minutes, and track action items to completion with cross-functional leads.Work with CMC teams to develop and optimize overall API, DP, and CTM timelines and project budget including resource planning (FTE, externals costs, outsourcing etc.).Ensure CMC functions are tracking to key deliverable and milestone timelines. Apply project management and technical expertise to monitor critical path timelines and resources.Inform CMC Team Lead of status, issues, problems, and proposed solutions and execute effective and timely communication to CMC line functions and management, and proactively communicate issues and concerns providing transparency with key stakeholders.Form sub-teams, as needed to resolve issues.Provide PM support, as needed, for management of critical vendors supporting the project, including participation in vendor management calls and review of vendor plans/timelines.Collaborate with CMC Lead, Finance and CMC line functions to assure that the team’s financial needs are accounted for in the overall budget and are tracking against spend projections.Recommend and manage CMC authoring & review activities and timelines in support of regulatory files, coordinating with Regulatory CMC lead and CMC Lead.Coordinate conducting Lessons Learned initiatives for the CMC teams as appropriate, e.g. post-major regulatory filing.Demonstrate excellent leadership skills to tactfully influence individuals at all levels of the organization.On a portfolio level (all projects), coordinate best practices across all CMC PMs.JOB QUALIFICATIONSEducation, Certifications, ExperienceBA/BS in a scientific or technical field. MS or PhD strongly preferred.Associate Director /Director expertise in at least one CMC functional area that directly contributes to successful drug development.Minimum of 16+ years industry experience, with at least 4 years project/program management experience.Knowledge, Skills and AbilitiesAble to analyze, summarize and present data to the stakeholders or decision makers.Demonstrated ability to work on multiple projects and meet timelines.Demonstrated ability to utilize project management tools successfully, e.g. Gantt charts.Strong written and verbal communication skills.Office environment / Domestic and International travel up to 25% may be necessary.Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.The expected salary range for this position is
$195,000 to $215,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit
https://www.gossamerbio.com/work-at-gossamerbio/
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$195,000 to $215,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit
https://www.gossamerbio.com/work-at-gossamerbio/
#J-18808-Ljbffr