Gossamer Bio · 2 days ago
Director, CMC Project Management
United States
Full-time
Remote
Director/Executive
$195K/yr - $215K/yr
16+ years exp
Maximize your interview chancesBiotechnologyHealth Care
Hiring Manager
Robyn R.
Insider Connection @Gossamer Bio
Get 3x more responses when you reach out via email instead of LinkedIn.
Responsibilities
Manage 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.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
BA/BS in a scientific or technical field.
Associate Director /Director expertise in at least one CMC functional area that directly contributes to successful drug.
Minimum of 16+ years industry experience, with at least 4 years project/program management experience.
Able 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.
Preferred
MS or PhD strongly preferred.
Benefits
Medical, dental and vision insurance
401(k) and 401(k) matching
Long-term incentive plan
Disability plan
Vacation pay
Sick time
Holiday pay
Work, personal and family time off in accordance with the terms of the applicable plans
Company
Gossamer Bio
Gossamer Bio is a biopharmaceutical company focused on the discovery and development of novel and differentiated therapeutic products.
51-200 employees
H1B Sponsorship
Gossamer Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$812MKey Investors
MidCap FinancialHillhouse Investment
2023-07-20Post Ipo Equity· $212M
2022-07-13Post Ipo Equity· $120M
2019-05-02Post Ipo Debt· $150M
Leadership Team
Faheem Hasnain
Co-Founder & Executive Chairman
Bryan Giraudo
Chief Financial Officer & COO
Recent News
2024-05-24
Company data provided by crunchbase
