This is a key technical expert and Project Management role within Industrial Development US. The primary main responsibilities of the Project Manager-Package Development is Project Management and technical leadership of CMC and packaging projects in the perimeter of NA Industrial Development in support of late stage NCE development, Rx to OTC Switches, Life Cycle Management Programs (LCM) and Commercial Products. This position formulates and submits technical strategy regarding packaging performance considering Regulatory compliance. It also investigates and recommends new packaging materials, systems and technology for potential use in sanofi packaging. This position will manage cross functional teams to formulate plans and strategy that meets the defined objective. The Packaging Project Manager will collaborate with R&D Drug Development, iCMC, Sanofi Industrial and third party CMO sites, Regional Marketing, Regulatory, Supply Chain, and QA in the development of project strategies and objectivesII - JOB SUMMARY*
The main responsibility of the Project Manager-Package Development is the Project Management and technical leadership of CMC and packaging projects in the perimeter of NA Industrial Development in support of late stage NCE development, Rx to OTC Switches, Life Cycle Management Programs (LCM) and Commercial Products. This position formulates and submits technical positions regarding technical performance and Regulatory compliance for sanofi packaging practices. It also investigates and recommends new packaging materials, systems and technology for potential use in sanofi packaging. This position will manage multi-functional team to formulate plans and strategy that meets the defined objective. The Packaging Project Manager will collaborate with R&D Drug Development, iCMC, IA packaging sites, Regional Marketing, Regulatory, Supply Chain, and QA in the development of project strategies and objectives
II A – PRINCIPAL ACCOUNTABILITIES (LIST 4-8)
- Represents Industrial Affairs in the development, qualification, dossier preparation and launch of new products. Participate as active member on: Project teams, Tech Transfer Teams, Launch Teams and Packaging Task Force sub teams.
- Acts as the CMC Project Manager for late stage developments, in-licenses and acquisitions by managing the internal Project Team for the scale-up, Registration and launch in the US/EU markets.
- Acts as a Project Manager to conduct or direct all phases of bringing a new or revised packaging to market with sanofi Global industrial sites and 3rd party alliances. Is responsible for project management including planning, timeline and budget management.
- Manages/supports the transfer of products between contract manufacturing sites and/or sanofi facilities.
- Evaluate primary packaging material systems as considerations to individual project objectives. Makes primary container-closure systems and material recommendations for new drug product stability programs based on product protection, technical performance and cost considerations.
- Directs the requirements for packaging material technical performance data to support registration.
- Identifies new packaging technologies and/or applications that could improve cost, compliance and quality and/or customer acceptance which improves industry positioning for sanofi-aventis.
II B– End Results/Impact
As lead Project Manager and technical expert, this position contributes to the development, registration, approval, launch and supply continuity of new and marketed solid and liquid oral dose products. Failure of these responsibilities can lead to inadequate product packaging resulting in stability failures, late registration or delayed approvals resulting in lost sales of new product introductions.
V – QUALITATIVE DATA
- Developing technical packaging solutions that meet the diverse requirements of inter-company functions. Needs to balance recommendations that meet the needs of groups.
- Defining the technical elements of packaging materials/systems what ensure a properly engineered system which does not result in performance failure either in the manufacturing process, the Industrial sites or in the market place.
- Securing the required input from Inter-company functions and external suppliers that need to factor into technical solutions.
DECISION MAKING AUTHORITY.
Definition of test/work to be performed, process and to some extent scheduling is generally at discretion of the position however execution is routinely reviewed with Department Management and the Industrial Development organization to ensure results/direction is consistent with objectives and deliverables.
KEY INTERNAL and EXTERNAL RELATIONSHIPS.
Works extensively across Regional and Global functions to develop appropriate solutions, including Drug Development, Consumer Health care, Industrial Development, Regulatory, QA and Compliance, Distribution, Supply Chain and Marketing Considerable interaction with packaging material suppliers.
VI – KNOWLEDGE AND SKILL REQUIREMENTS (Minimum requirements for assignment to this job.)
- Solid project management skills with varied scope and complexity with multi-functional/organizational project teams.
- Demonstrates comprehensive knowledge of solid and liquid oral primary packaging material types and their technical performance characteristics, cost and manufacturing processes.
- Working knowledge to advanced understanding of principles and applications behind the packaging materials testing and performance requirements defined in USP, ASTM, ISTA, IATA, CFR and FDA Guidance's.
- Has comprehensive knowledge of the related pharmaceutical customer, supply and distribution requirements and considers their wants/needs into packaging solutions.
- Has knowledge of FDA Regulations regarding required documentation and data to support new product registrations and various types of changes to primary packaging materials.
Type and Length of Experience (indicate how typically obtained):
- BS Packaging or 5-8 years pharmaceutical industry or technically related experience.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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