Eyepoint Pharmaceuticals Watertown , MA 02472
Posted 3 weeks ago
Overview
Be Seen and Heard at EyePoint Pharmaceuticals
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for:
We See You.
Your wellbeing
Your professional worth
Your future at EyePoint
EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.
EyePoint is seeking a Senior Program Manager, CMC/Sr. Manager, Program Management, CMC to manage R&D activities from Phase 3 through launch. This position will report directly to the Sr Director, Portfolio Management.
The Senior Program Manager, CMC/Sr. Manager, Program Management, CMC is responsible project related activities including project plans, dashboards, timelines, budgets, decisions, critical path items, and milestones for the Watertown site. In this position, the Senior Program Manager will work across functions to ensure successful progress towards EyePoint's goal to help improve the lives of patients with serious eye disorders.
Responsibilities
Primary responsibilities include, but are not limited to, the following:
Serve as Senior Program Manager, CMC/Sr. Manager, Program Management, CMC within R&D, primarily interacting with CMC, Device, Preclinical, Quality and Regulatory Affairs departments.
Manage cross-functional team activities related to key deliverables for regulatory filings (e.g. IND amendments, NDA).
Work with key stakeholders to develop, track, and maintain cross-functional timelines, budgets, forecasts, and project plans
Support development teams by maintaining meeting agendas, decision logs, action registers, meeting minutes and holding team members accountable for deliverables.
Collaborate with project teams to identify project risks, bottlenecks, and contingencies
Drive teams to continuous improvement through identification of lessons learned
Qualifications
Primary skills and knowledge required include, but are not limited to the following:
Working knowledge of pharmaceutical and combination product development timelines, with direct experience working on CMC, Quality, and Regulatory milestones. Strong understanding of GMP manufacturing and CMC
method development
Demonstrated ability to balance priorities with strong attention to detail.
Excellent organizational and communication skills.
Highly self-motivated with a desire for career growth.
Extensive working knowledge of MS project, Smartsheet, Power Point and Excel.
Highly Desirable Skills:
Phase II/III experience strongly preferred
Knowledge of combination product requirements
Level of Education Required:
Minimum of a Bachelor of Sciences Degree, advanced degree preferred. PMP certification desired.
Preferred Field of Study:
Pharmaceutical sciences or related field of study
Number of Years of Experience in the Function and in the Industry:
Minimum of 5 years in biotech/pharma with 2+ years of Project/Program Management experience
Envision Your Future
With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.
The collective power of our values influences everything we do, and everything we do for you.
Success begins with our People
Patients First
Integrity
Results-Driven
Innovation
Team Focus
Diversity & Inclusion
EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
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Eyepoint Pharmaceuticals