$100K — $110K
Position: Project Manager
Location: New York, Central Islip (11749)
Duration: Full time
REQUIRED CITIZENSHIP / WORK PERMIT / VISA STATUS:
US Citizen / Green Card Holder / H1B
The candidate must have a Masters Degree in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
Must be experienced in Microsoft Office and Microsoft Projects
Experience in ERP/SOPs
Must have at least 5 years of relevant technical experience in a pharmaceutical setting
Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a must.
Project Leadership or Project Management or Alliance Management
Prior experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs)
Experience with project governance practices is a must.
Excellent organization skills in a must.
NICE TO HAVES:
PhD in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
Project Management Professional (PMP) Certificate
The Project Manager position is a highly visible individual contributor role that reports to the 6AD of Project Management, R&D, North America. The job duties for this position include but are not limited to the following:
· Responsible for end-to-end project leadership and management (scope, cost and time) deliverables for Client’s projects.
· In a dual-leadership structure on projects, operate as a Project Leader (PL) along with a project Technical Leader (TL).
· Operate as the primary liaison and project manager on Internal /external partnerships of Client’s North America. Responsible for delivery on the projects to agreed and planned scope, time, cost and quality.
· Operate as the single point of contact for Client’s internal stakeholders on all aspects of projects. Internal stakeholders include but limited to executive management committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs, regulatory affairs, quality assurance, procurement etc.
· Act as the custodian of the project governance process. Responsible for stage-gate reviews and escalation of topics, as required. Responsible for maintaining a Client’s s version of project plan for all external partnerships. Responsible for drafting and delivering presentations to executive management.
· In collaboration with Client’s commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness.
· Responsible for collaborating with Client’s global stakeholders particularly Integrated Product Development (IPD) and Quality Assurance (QA) to incorporate technical best practices including QbD principles in all technical studies.
· Participate and/or lead technical due diligences on projects where Client’s is actively engaged with a potential partner to in-license or co-develop a product.
· Maintain a pro-active, informed and nimble approach for all aspects that may affect the delivery of the projects to approved plan.
· Maintaining strategic alignment between the program, organization and stakeholders
· Provide relevant feedback to Client’s commercial and portfolio functions on assumptions, risks and market developments leading to development of commercial models.
· Lead and implement a risk-based approach towards assessment of projects, project milestones and stage gate reviews.
· Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to relevant stakeholders.
· Maintain effective and pro-active communication and coordination of activities with multi-functional internal and external stakeholders.
EDUCATION AND EXPERIENCE
· Ph.D.or Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, Medicinal Chemistry or Chemical Engineering.
· Project Leadership or Project Management or Alliance Management experience is a must.
· 6 + years of relevant industry work experience is a must.
· Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a must.
· Project Management Professional (PMP®) certificate or other relevant project management training is a plus.
· Knowledge of SAP system is plus.
· Prior experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs) is a must.
· Experience with project governance practices is a must.
· Excellent organization skills in a must.
PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLS
· Must possess excellent communication skills.
· Must have experience with drafting project plans and budgets.
· Must be able to negotiate and communicate across organization reporting lines.
· Must possess strong documentation and technical writing skills. Must be able to apply relevant scientific principles and practices.
· Must be able to work independently under minimal supervision and in a team environment.
· Must be able to exercise appropriate professional judgment on matters of significance.
· Must be proficient in computer skills and software applications such as Microsoft Office tools.
OTHER JOB INFORMATION
· Relocation negotiable.
· Ability to travel domestic and international approx. 25% of the time.
Valid through: 6/17/2021