The Project Manager will lead cross functional project teams, including internal and third party, to drive development, validation and launch activities for the U.S. Generics solid oral dose portfolio. using project management methodologies and best practices to deliver projects on time. The incumbent will be working in a fast paced and dynamic team environment handling a varied portfolio of high visibility projects with many stakeholders and sometimes competing priorities.
The candidate must have project management experience in the generic pharmaceutical industry and with generic development of solid oral dosage forms. Experience in soft gels, capsules, transdermal delivery systems, liquids, sublingual films, injectables a plus.
Primary responsibilities include, but not limited to, managing activities leading to the successful execution of the project; establishing project plans with milestones and deliverables in collaboration with stakeholders (CMO, R&D, Regulatory Affairs, Supply Chain, etc.); conducting scenario planning and risk assessments; and ensuring accountability of team members for deliverables. Additionally, the Project Manager will communicate across functional and leadership levels to inform project status and risks, as well as elevate issues, present recommendations and implement modifications to project plans. Position will include some travel.
Secondary activities may include cross functional / cross project assignments in the R&D arena, along with departmental initiatives and infra-structure build to ensure that project management best practices are being employed across projects.
This position reports to the Senior Director of Project Management. This position has no direct reports.
- Serve as leader and prime advocate for your projects.
- Lead issue oriented project meetings; mediate and resolve conflicts; and drive teams to success.
- Proactively shepherd projects thru the Stage Gate process.
- Issue written agendas in advance of meetings and timely distribution of minutes.
- Follow-up on action items between team meetings and ensure accountability of team members.
- Develop and implement project plans.
- Maintain SharePoint and other databases with project status and key project information.
- Liaison with third party partners and suppliers.
- Interface with all levels of management and ensure alignment throughout the organization.
Be a model of superb organization, excellent timeliness and tireless follow up.
- BA or BS degree in science from accredited college or university.
- Seasoned pharmaceutical project management professional plus a minimum of 5 years’ project management experience in the generics pharmaceutical industry.
- Understanding of solid oral dose equipment and processes. Experience in cGMP pharmaceutical R&D and / or Manufacturing Operations a plus
- Experience with ANDA drug development and product launch.
- Experience with working with third party CMOs on development and project launches.
- Strong analytical skills and business acumen.
- Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables.
- Proficiency in MS Office, MS Project, and SharePoint.
- Strong oral interpersonal and written communications skills.
GMP DECISION-MAKING AUTHORITY
No Decision Authority
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