Project Manager-Pharma CDMO

About Ascendia Pharmaceuticals:

Ascendia is a Contract Development and Manufacturing Organization (CDMO) company dedicated to enabling formulations for pre-clinical and clinical stage drug candidates and developing enhanced formulations of existing drug products. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-milling, injectable, lipid nanoparticles, and oral controlled release. Ascendia provides development, manufacturing and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.

The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over their disease and enhance quality of life.

About the Position:

The Project Manager will lead cross functional project teams, including internal and third party, to drive research and development activities for the U.S. CDMO business. This position will use project management methodologies and best practices to help the project teams deliver projects on time and within budget. 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 pharmaceutical industry.

Primary responsibilities include, but not limited to, managing activities leading to the successful execution of the project; establishing and tracking project plans with milestones and deliverables in collaboration with stakeholders (R&D head, Formulation Scientists, Analytical Scientists, Manufacturing Operations, 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 may include some travel.

Secondary activities may include cross functional / cross project assignments in the R&D arena, along with company initiatives and infra-structure build to ensure that project management best practices are being employed across projects.

This position reports to the R&D head. This position has no direct reports. Full-time, part-time, or other flexible arrangement will be considered.

Principal Responsibilities:

Plan and implement projects, help define project scope, goals, deliverables; and define tasks and required resources.

Serve as leader and prime advocate for your projects, assembly, manage, support and direct project team.

Manage budget, allocate project resources, create schedule and project timeline, track deliverables and monitor and report on project progress.

Present to stakeholders reports on progress as well as problems and solutions, and implement and manage change when necessary to meet project outputs.

Evaluate and assess result of project, serve as leader and prime advocate for your projects.

Lead issue oriented project meetings; mediate and resolve conflicts; and drive teams to success.

Follow-up on action items between team meetings and ensure accountability of team members.

Maintain Shared File System and other databases with project status and key project information.

Interface with all levels of management and ensure alignment throughout the organization.

Be a model of superb organization, excellent timeliness and tireless follow up.

Qualifications

Undergraduate or graduate degree in science or business from an accredited college or university.

Pharmaceutical/Life Sciences project management professional plus a minimum of 1 year of project management experience in the pharmaceutical industry with Project Management Professional (PMP) certification or equivalent is desirable.

Understanding of formulation development, manufacturing processes, and experience in pharmaceutical R&D and cGMP Manufacturing Operations is a plus.

Experience with IND, NDA, NDA 505(b)2, BLA, and ANDA drug development.

Proficiency in MS Office, MS Project and other project management tools.

Experience with working with third party clients on product development projects (CDMO).

Strong analytical skills and business acumen.

Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables.

Strong oral interpersonal and written communications skills.

EEO/AA M/F/V/D

Please visit our website at https:///ascendiapharma.com for more information. To apply, please submit your CV or resume to HR@ascendiapharma.com.