Job Title: Lead, Site MSAT - Global Pharmaceutical
Contract Type: Permanent
Pay: competitive + bonus, car allowance, medical care, shares, pension
Location: Barnard Castle
Lead the Manufacturing Science and Technology (MSAT Team) for Barnard Castle, portfolio of products in New Product Introduction, Sterile manufacturing, clean liquids and dermatological 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 Barnard Castle, aligning with central teams and technical stewards. The director will lead a team of technical individuals, focused on developing technical capability and future leaders within the technical organization.
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, Scale Up 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.
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 Verification (CPV) for products manufactured at the Barnard Castle 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 GSC technical community for timely resolution.
Serve as part of the MSAT community, providing input to technical discussions and strategic programs.
Proactive Talent Management, including succession planning and capability build within the MSAT team.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Extensive industrial experience in technology/biopharmaceutical process development, technical project management and process transfer to production in a biopharmaceutical/biotechnology manufacturing environment.
Prior experience leading groups in a biopharmaceutical/ biotechnology manufacturing environment involved with technology development and process transfer expected to exceed 5 years.
Prior experience with biopharmaceutical product registration preferably with FDA and/or EMEA.
Knowledge of current GMP's, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes required.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Strong interpersonal and senior 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.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy