Specialist, Analytical Sciences MS&T

Job Description

An amazing opportunity has arisen for a Specialist, Analytical Sciences, MS&T.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Provide analytical support to the Process Sciences Team at Biotech Dublin.
• Provide specialist analytical support to Quality Control for characterisation and non-routine analysis and troubleshooting.
• 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.
• Support the transfer of new analytical methods into the analytical sciences laboratory.
• Provide Analytical support and expertise to the network.
• Deviation management – support site-related analytics deviations.
• Authoring and reviewing standard operating procedures and technical reports.  Support global regulatory submissions as needed.
• Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting.
• Assuring effective application of LeanSixSigma and Change Management tools in the Analytical Sciences group by:
  • Securing continuity of an appropriate level of knowledge.
  • Facilitating problem solving & risk assessment (FMEA) projects/meeting.
  • Making problems visible and striving for continuous improvement.
• Serving as an analytical specialist during internal audits and external inspections/audits
  • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
  • Supporting authoring and maintenance of the site master validation plan.
• Represent the organization and company in external collaborations and present technical outcomes at scientific and professional conferences and forums as required.
• Keep up to date with scientific and technical developments.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

What skills you will need:

In order to excel in this role, you will more than likely have:

• This role requires an experienced individual with a minimum of 2 years’ directly related analytical experience in academia, pharmaceutical or biotechnology company –with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• A self-starter and results-focused, 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.
•  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.
•  Bachelor’s degree (or higher) in Analytical Sciences/Chemistry/Biological Science,.
• Experience with assay development and qualification of biologics assays (HPLC,UPLC-based).  Familiarity with potency assays, including cell-based assays would be useful.
• 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. 
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
• Experience with upstream cell culture and downstream purification of biological molecules.
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R284482