Injectables Project Leader

Job Title: Injectables Project Leader

• Location: Swiftwater, PA

About the Job

The mission of this position is to provide matrix cross-functional leadership and strategic oversight across the full project lifecycle, driving CMC and Tech Transfer initiatives while managing cost, resources, and schedules to align with both technical and commercial objectives. Serves as a subject matter expert for injectable drug product filling development, and validation, leading tech transfers, new vaccine programs, and continuous improvements in compliance with Sanofi guidelines while delivering technical coaching and solutions across projects and programs.

The mission of the MSAT function is to deliver robust and efficient processes with associated knowledge to transfer to Manufacturing. The MSAT function also provides daily support to manufacturing toward industrial performance excellence. 

About Sanofi:

 We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities

Project Leadership :

• Matrix cross-functional leadership and strong understanding of project management/business/financial and life cycle management of projects with focus and understanding of CMC and Tech Transfer.

• Understand and support the strategic vision on the future of the product, both technically and commercially.

• Anticipate variations in schedules, skill needs and conflicts to efficiently utilize resources, including planning for peaks in workload.

• Accountable for the development of cost and resource structure of project throughout the life-cycle.

• Comply with sanofi guidelines and practices as a leader for drug product tech transfers, new vaccines and continuous improvements.

• Responsible for technical coaching, training, and guidance from a project perspective for specific projects and programs.

• Responsible to propose and deliver technical solutions as a subject matter expert for Drug product formulation and filling development and validation related to specific products.

Validation Leadership:

• Lead and ensures technical validations and projects related to Formulation, Filling and / or Inspection activities are executed on-time and on-budget across the M+S project portfolio in line with business, production, and resource constraints.

• Lead the completion of technical assessments and risk assessments for Drug Products including Deviations, Change Management and CAPAs

• Develop and lead documentation and deliverables to satisfy regulatory guidelines for new and legacy products. Author, review and approve Injectables procedures, development, and validation reports.

       About You  

Required Qualifications

Requirements:

• Bachelors degree in life sciences, math, engineering, or pharmacy.

• 6+ years experience in biological/pharmaceutical manufacturing processes or analytics in a cGMP environment. (At least 4 years of experience with project management, leading and developing teams).

• Must have excellent written and verbal communication skills, as well as the ability to actively and cooperatively work with cross functional teams.

Preferred qualifications:

• Advanced degree, Masters or PhD in lifesciences, math, engineering, or pharmacy.

• Experience working in Drug Product validation is highly preferred.

• Certifications: Operational excellence/Lean Six Sigma certification – green or black belt or other certifications.

Key Technical competencies and soft skills:

•  Must have the ability to communicate verbally and in written form effectively through multiple layers of the organization.

• Experience interacting with regulatory agencies and health authority inspections is required.

• Excellent organizational, interpersonal and leadership/teamwork abilities are required.

• A strong customer focus and ability to prioritize and adapt to business and manufacturing needs are required.

• Diverse business and industrial manufacturing knowledge base.

• Demonstrated experience in developing, aligning, socializing, monitoring, adapting, and delivering strategies in dynamic, rapidly changing environments

Why choose us?