MSAT Bio DP Site Director

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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

Key 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 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

Qualifications

Education:

• Minimum of a Bachelors and/or equivalent University Degree; required.

• Masters degree in bioengineering life sciences pharmacy (or similar) and experience in the respective field; preferred

Experience and Skills:

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.

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.

Other:

• This position may require up to 30 % of domestic or international travel based on project business needs

While this role will ultimately support the site operations located in Wilson NC this role will also be required to support the project phase across both design & construction. For the project design phase the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed this role will support the construction and operational start-up of the site. For this you will be required to be on site in Wilson NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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