Project Management Lead, R&D

Posting Date:Apr 19, 2024

Country:United States

State:New York

Location:Central Islip

Req Id:84016

Project Management Lead, R&D-Central Islip, NY:Works under the supervision of the Director of Project Management. This position is responsible for handling R&D activities under Life Cycle Management, organizing meetings with all right stakeholders. Prepare operations plans and schedules to assist management in operating more efficiently and effectively. Conduct work simplification and measurement studies. Participate in due diligence on projects where Cipla is actively engaged with a potential partner to in-license or co-develop a product. Responsible for end-to-end project leadership and management (scope, cost, and time) deliverables for Cipla projects. Operate as a Project Leader (PL) along with a project Technical Leader (TL). In collaboration with Cipla commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness. Operate as the primary liaison and project lead on Internal /external partnerships of Cipla North America. Responsible for delivery on the projects to agreed and planned scope, time, cost, and quality. Act as the custodian of the project governance process. Responsible for stage-gate reviews and escalation of topics, as required. 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. 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.

Qualifications and Requirements:

• Applicant must have a Master's Degree in Project Management, Pharmaceutical Sciences, or Business and Science and three (3) years of work experience in Pharmaceutical Manufacturing.
• Must have a detailed understanding of product development including effective scheduling, estimating, and workflow processes in a generic pharmaceutical environment.
• Applicant must have strong knowledge of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products.
• Experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs) 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.
• Must be able to prioritize assigned development of multiple projects.
• Experience with project governance practices is a must.
• Strong knowledge of Clean- In- Place and Sterilization- In- Place techniques and cleaning procedure for equipment using Cleaning Development Protocols.
• Demonstrate acceptable skills in oral and written communications, independent judgment, teaching and training, problem solving/decision making, adhering to timelines, negotiation skills, integrity, and adaptability.

40 hours per week: M-F. 9am-5pm. Must have proof of legal authority to work in the United States. Travel Required Infrequent/Domestic less than 10%. Salary $129,688.00-$130,000.00 per year.

EMPLOYEE REFERRAL PROGRAM GUIDELINES

InvaGen Pharmaceuticals, Inc. is always looking for good people like you, to join our growing team. Research has shown and our own experience supports this, that new hires that come into a company through employee referrals are excellent contributors, stay with the company longer and are a more cost-effective recruit.This is where you come in! If you know someone who would be a good addition to the InvaGen Pharmaceuticals, Inc. team and they meet the qualifications for an existing open requisition, it may be worth $300.00 if you refer them for employment and they are hired!Refer candidates who meet the qualifications to the Human Resources Department. If your candidate is hired, you will be awarded $300.00 after he/she completes 90 days of employment.

Referral Eligibility and Program Rules:

• All InvaGen Pharmaceuticals, Inc. employees, except Directors and Officers with hiring authority over the referred candidates are eligible to refer candidates.
• The referral must represent the candidate's first contact with InvaGen Pharmaceuticals, Inc. Temporary, summer, contract, and former employees of InvaGen Pharmaceuticals, Inc. are not eligible candidates for referral awards.
• Only candidates who meet the essential qualifications for the position will be considered.
• All referral bonus payments will be paid after the referred candidate has been employed for ninety (90) working days at InvaGen Pharmaceuticals, Inc.