Job Purpose
The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure site goals and objectives are achieved. The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team is also responsible for delivering continuous improvements and working with site stakeholders and global MSAT to execute projects and implement process-related improvement programs across the product lifecycle.
This position will serve as the site technical expert on site impact assessment, technology transfer, process validation (PV), regulatory inspections and submissions, and product lifecycle management (PLM). This individual will support project teams to deliver key PV / PLM milestones across all stages of the product lifecycle including material/processes changes for cost benefits. The manager MSAT will be expected to lead technical strategy for regulatory responses for product related PSIs/queries, inspection readiness, and audit support within the MSAT team. The manager MSAT will be responsible for staying current with lifecycle management strategy and driving continuous improvement, delivering step changes in process efficiency and deriving simplification in process.
In addition, this individual will be expected to support technical capability development in the PV / PLM space for the site MSAT team. Manager MSAT is expected to manage within a matrix team, collaborating with team members from other departments (i.e. production, quality, engineering) and with stakeholders in central MSAT, supply chain, and SMEs.
Education, Experience & Skills
PharmD/BS in either biological or chemical science or engineering or equivalent technical discipline.
3-5 years’ experience in the pharmaceutical industry or equivalent with significant emphases on process technology transfer and validation and regulatory compliance. OR a hands-on experience in MSAT, product development, new product introduction and product lifecycle management
Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Embraces a team-based culture.
Demonstrates initiative to solve problems, investigate deviations, and provide subject matter expertise for products and processes where needed
Key Responsibilities
Serve as the site technical expert for process validation and product lifecycle management, owning the validation / PLM framework and strategy at site to drive the delivery of right-first time new product introduction and commercial lifecycle management
Drive innovation, digital tool implementation, and continuous improvement for PLM approaches, utilizing CoPs and industry forums to stay current on regulatory guidance and industry trends
Develop and provide training for MSAT team members on PLM / PV concepts
Support the implementation of standards and processes in areas such as CPV, ASP, PV as per current industry practices and ensuring simplification in ways of working
Serve as liaison between site MSAT team with relevant SMEs in the region to pull support for projects execution
Derive PLM improvements to support continuous improvement initiatives to delivery business benefits in coordination with other functions
Ensure governance of materials change projects across site
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.