Principal Scientist – Upstream Process Lead (Director level role)
MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.
We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.
In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.
With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.
MSD BIOTECH, DUBLIN
The latest addition to the MSD Ireland family is MSD Biotech, Dublin. The site will play a pivotal role in the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology, and will expand MSD’s current internal network of biologics drug substance manufacturing plants when full manufacturing operations begin in 2021.
MSD Biotech Dublin, will be MSD’s first ever Large-Scale Mammalian-Based Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.
This facility will be a significant supplier of drug substances for one of MSD’s key treatments and will also be critical in the future supply of new biotechnology products to its global network.
Reporting to the site manufacturing and technology head and based at the MSD Biotech Dublin site, the Upstream Process Engineering leader responsibilities include, but are not limited to the following:
- Provide oversight of the design, construction and qualification of the new cell culture installation at MSD Biotech Dublin through to technology transfer and commercialization. Support establishment of the commercial process and routine manufacturing by:
o Serving as a cell culture commercial manufacturing process subject matter expert, providing technical oversight to teams, and coaching to associate staff. Provide technical leadership for:
Experimental design, execution, data analysis and interpretation.
Interpretation of trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
Change control prioritization and implementation.
o Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
o Leading multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
o Assuring effective application of LeanSixSigma and Change Management tools by:
Securing continuity of an appropriate LSS/CEM level of knowledge.
Leading by example in achieving results by using high performing organization (HPO) tools and processes
Facilitating problem solving & risk assessment (FMEA) projects/meeting.
Making problems visible and strive for continuous improvement.
o Serving as a key member during internal audits and external inspections/audits
o Supporting alignment and knowledge exchange with other commercial nodes and external manufacturing partners.
o Supporting authoring and maintenance of the site master validation plan.
- Manage and coach a staff of 4-6 engineers.
- Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Represent the organization and company MSD in external collaborations (BPOG, NIIMBL, etc) and present technical and strategic outcomes at scientific and professional conferences and forums.
- Keep up to date with scientific and technical developments.
- Support creation of the departmental budget and surveil actual performance against the forecast.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
This role requires an experienced individual with a minimum of 8 years’ (for PhD), 12 years’ (for MSc) or 14 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
- Experience with upstream cell culture and downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
- Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes
With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within MSD.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
So, if you are ready to:
INVENT solutions to meet unmet healthcare needs
IMPACT the future by joining MSD, one of the world’s leading healthcare companies
INSPIRE your team to reach their full potential and push the boundaries of science and technology