Head of Site MSAT

GSK

10h•Onsite

About The Position

Join GSK as Head of Site MSAT in Rockville, MD! Are you passionate about leading with cutting-edge science and engineering to drive business performance? Do you thrive in a role where you can inspire and cultivate a culture of excellence? If so, our Head of Site MSAT (Manufacturing, Science, and Technology) position at our Rockville, MD biopharmaceutical manufacturing site is the perfect opportunity for you! Why GSK? As a global leader in biopharmaceuticals, GSK offers a dynamic environment where innovation meets impact. Our Rockville site is at the forefront of scientific advancements, and we are looking for a visionary leader to take our MSAT team to new heights. As Director of Site MSAT, you will lead the Manufacturing Science and Technology (MSAT Team) for Rockville Biopharm, focusing on delivering new biopharmaceutical products, applications and technologies and managing product lifecycle, including delivering improvements to the existing supply chains. The MSAT lead will focus on performance, delivery, capability, development, and talent management to enable the site to meet business goals. This individual will develop strategy for technical products at Rockville, aligning with central teams and technical brand leads. The director will lead a team of technical individuals, focused on developing technical capability and future leaders within the technical organization This role will provide YOU the opportunity to lead key activities to progress YOUR career.

Requirements

Bachelor’s degree in engineering, chemistry, pharmaceutical sciences or related scientific discipline.
Minimum of 10 years industrial experience in technology/biopharmaceutical process development, technical project management and process transfer to production in a biopharmaceutical/biotechnology manufacturing environment.
Minimum 5 years' experience leading groups in a biopharmaceutical/ biotechnology manufacturing environment involved with technology development and process transfer.
Prior experience with biopharmaceutical product registration preferably with FDA and/or EMEA.
Experience with current GMP's, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes required

Nice To Haves

Masters or PhD in appropriate scientific or technical discipline.
Strong interpersonal and leadership skills.
Committed team player prepared to work in and embrace a team-based culture.
Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines
Strong verbal and written communication skills which emphasize teamwork with a strong quality orientation.
Excellent judgment.
Able to prioritize and decide appropriate courses of actions.
Effective at implementing decisions.
Proven track record of accomplishment

Responsibilities

Ownership of the core technical business processes for site: Product Lifecycle Management (Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment), New Product Introduction and Technical Transfer to other sites/third party manufacturers.
Serve as a member of the site leadership team by supporting site initiatives, providing input to the site strategic direction, and supporting matrix leadership across other core business functions
The MSAT director will direct the transfer of DS biopharmaceutical production processes and technologies from R&D, third party clients, or MSAT labs to/from Rockville Biopharm.
Oversee product technical lifecycle management with regards to process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registered detail.
Champion business cases for manufacturing technology implementation or other strategic projects.
Be accountable for activities to facilitate Continued Process Verificiation (CPV) for products manufactured at the Rockville site.
Provide technical leadership for the rapid resolution of technical issues impacting supply through and product performance investigations through use of root cause analysis (RCA) tools and appropriate Corrective And Preventative Actions (CAPA), and escalate key site technical issues to the wider GMS technical community for timely resolution.
Serve as part of the GSK technical community, providing input to technical discussions and strategic programs.
Proactive Talent Management, including succession planning and capability build within the Technical team