Fall River Lead Project Manager

Job Title

Project Manager

Organization Name

Inva Gen Pharmaceuticals

Location

7 Oser Avenue, Happauge NY 11788

Employment Type

(Hourly/ Full Time)

Full Time - Salaried/Exempt

Salary Range

(Base/ Hourly)

$100K-$125K

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

Work Hours/ Shift/ Remote

8:30 AM - 5:00 PM

Responsibilities/ Accountabilities

* The Project Manager position is a highly visible individual contributor role that reports to the Director 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 Cipla projects.

* Operate as the primary liaison and project manager on Internal /external partnerships of Cipla 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 Cipla 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 Cipla s version of project plan for all external partnerships. Responsible for drafting and delivering presentations to executive management.

* In collaboration with Cipla commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness.

* Responsible for collaborating with Cipla 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 Cipla 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 Cipla 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 Qualifications

* Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, Medicinal Chemistry or Chemical Engineering.

* Project Management Professional (PMP) certificate or other relevant project management training is a plus.

Experience

* 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.

* Experience in handling complex injectable and Inhalation.

* Prior experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs) is a must.

* Handling Green field project is plus.

* Experience with project governance practices is a must

Skills/ Competencies

* SAP experience

* Must be proficient in applicable computer and database applications including MS Word, MS Excel, PowerPoint, and PDF.

* Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

* Demonstrable acceptable skills in oral and written communications, independent judgement, problem solving and effective managing and adhering to timelines.

Physical Requirements

* Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Other Information

No remote work available. Relocation available.

About Cipla

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical…