MSAT Bio DP Site Director

Johnson & Johnson•Wilson, NC

About The Position

The MSAT Bio DP Site Lead is responsible for directing the Site MSAT team in defining and delivering a validation strategy and vision aligned with corporate direction, regulatory/compliance requirements, and internal/external benchmarks. This role will provide strategic leadership for local and global projects, drive the adoption of new technologies, and enhance engineering efficiency. Shaping operational strategy by developing plans aligned with business objectives and delivering MSAT functional strategies. The role leads standards deployment, PAT, and technology integration, and ensures timely execution of equipment and cleaning validation as well as flexible NPI/LCM technology transfer. They represent MSAT on the Bio DP Site Leadership Team

Requirements

Minimum of a Bachelor's and/or equivalent University Degree; required.
A Minimum of 15 years of experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
Familiarity with cGMP and regulatory aspects in validation
Knowledge of both Pharmaceutical Manufacturing and MSAT functions and experience with Bio DP and Parenterals.
Excellent written and oral communication skills and ability to influence peers, superiors, and partners.
Motivated, self starter able to work independently with demonstrated problem solving skills.
Strong expertise on pharmaceutical manufacturing processes and products, equipment with focus on sterile manufacturing.
Solid understanding of Quality & Compliance / regulatory requirements (GMP) especially for sterile manufacturing.
Project management (FPX), organizing, planning and coordination skills.
Prior people leadership experience.

Nice To Haves

Master’s degree in bioengineering, life sciences, pharmacy (or similar) and experience in the respective field; preferred
Experience pharmaceutical development or pharmaceutical manufacturing
Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.
Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.

Responsibilities

Lead the MSAT Bio DP Site team to achieve annual MSAT/site goals by ensuring end-to-end compounding, filling, visual inspection, and device assembly processes for equipment and product.
Represent Site MSAT in Site Leadership team and in MSAT Bio DP Platform
Lead or sponsor high-visibility, complex projects and programs with significant business implications.
Responsible for strategic framework around Bio DP parenteral products.
In conjunction with other key teams to develop and deploy a JJIM enterprise methodology on a Gravel-to-Grave process on robust aseptic manufacturing
Single Point of Contact (SPOC) for MSAT needs for Bio DP and parenteral products at new DP node with regard to aseptic manufacturing processes, sterilization technologies, visual inspection and validation
Proactively promote quality and compliance in the areas of sterile manufacturing and validation and coach others to do the same
Manage a highly engaged MSAT team providing strategic leadership and direction aligned with the global Bio DP network.
Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.
Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations
Lead and supervise a team of engineers and scientist.
Coach, develop and guide team towards company, platform and team goals & objectives