Scientist

Scientist MSAT LMDS

Location: Cork

Working mode: Hybrid

Duration: 12 months (opportunity for a contract extension)

Hours: 39 hours per week

Pay rate range: Competitive hourly rate

This role is responsible to lead the coordination of technical services activities across the large molecule platform.  In this role the incumbent is charged with managing New Product Introduction and Life-Cycle Management projects that must drive reliability and sustainability of our Parenteral bulk drug substance manufacturing plants and products. This person will provide the overall project portfolio management and leadership role to lead and facilitate the activities related to all technical support related to establishing standardized Design-to-Value strategies in the Janssen’s Biologics Drug Substance Supply Chain network, for both internal and external manufacturing facilities.

This role will partner with R&D, Quality, and Regulatory to ensure processes are flawlessly introduced into and managed through the supply chain network and that models are developed and utilized to ensure both new and ongoing production consistently satisfies quality and regulatory needs.

The incumbent must be able to work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in depth evaluation of various identifiable factors in multifunctional areas, and must have strong communication skills to influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties. Strong knowledge in biologics bulk drug substance manufacturing processes and regulatory filing experience is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable.

roles and responsibilities

• Represent global tech services and partner with operation, R&D, regulatory and quality to develop and implement a strategy for standard manufacturing practice, new product introduction and marketed product support across large molecule product portfolio. 

• Responsible to assure ensure manufacturing site readiness, reliability and sustainability.  

• Accountable technical lead for identifying new technology or areas of improvements on current and future processes, capital utilization, cost of goods optimization, and advanced expertise on feasibility and risks management.

• Strengthen external network of academic, regulatory, professional and cross company alliance s to enhance standardization of current approaches and introduction of new technologies across platforms and industry.

• Oversee Process validation, FDA filing activities.

• Coordinates and executes product introduction at the site from drug substance (DS) transfer through launch covering raw materials and process integration. 

• Supports the New Product Launch teams for site related launch activities.

• Delivers clinical through commercial Drug Substance supply from the manufacturing site ensuring manufacturing performance, cost, and robustness requirements are met.

• Provides required manufacturing technical support, documented technical input, review, and approval and serves as the JSC technical expert. Represents JSC in all Design-for-Manufacturability (DfM) activities during the development process.

• Responsible for delivering a Drug Substance process capable of meeting the Gross Profitability targets together R&D, Finance and Operation, and conduct Cost-of-Goods (COGS) sensitivity assessments.

how to succeed

Specific knowledge 

• Proven track record in large molecule process development, new product introduction and ongoing production support of large molecule pharmaceutical products.  Had accountability and success for design, start-up, and approval of both facilities and products within the large molecule space.  Well established industrial, academic and regulatory track record. 

• Demonstrated competency and experience with introduction of Drug Substance products to manufacturing sites and thorough technical knowledge of manufacturing site unit operations.

• Understanding of costing systems to support COGS sensitivity assessments as well as financial tools such as NPV, P&L and make vs buy tools. 

• Integration of new and re-developed DS manufacturing processes from R&D into the supply chain.

• Tech transfer from R&D facilities, internal and external, to plants in the JSC network.  The scope includes early development, full development, launch phase and life cycle management.

• Contribution, review and approval of DS technical and regulatory documents, routine technical support during execution, integration of Janssen Supply Chain (JSC) technical expertise into project execution

• Single point of contact for JSC plant readiness and execution from technical transfer into commercial production.

• Identifying and implementing opportunities for active decrease in DS COGs.  Taking part in GP assessments led by the NPL.

• Partnering with R&D and JSC groups to improve the fit for plant and commercialization of new products into the supply chain.

Personal and interpersonal skills / Leadership skills 

• Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites. Planning and logistics skills capable of effective integration of DS deliverables at the manufacturing site level.

• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.

• Ability to influence and lead peers, superiors, and external partners.

Personal attitude and mindset 

• Motivated, self-starter able to work independently with demonstrated problem solving skills.

DEGREE:

Engineer, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering). Scientist level will require 2-4 years of experience. 

LANGUAGES:

Excellent written and oral communication skills in English.

SPECIFIC SYSTEMS:

• Document mgmt. systems such as ERIS DocSpace, SAP, MS Office applications

• TrackWise 

• Instantis

• Minitab or similar statistical software

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note we do not accept applications via email). 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.