Senior Specialist in Analytical Science

3 weeks ago


Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.

Senior Specialist in Analytical Science

Job Purpose:

The Sr Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the site, particularly Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing, and Quality Control, acting as Analytical Method and PAT SME while taking a lead in utilizing the latest innovations in technology and automation to create a workplace of the future.

Requirements

Primary Responsibilities:

  • Serving as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching to associate staff.
  • Provide technical leadership for experimental design, execution, data analysis, and interpretation.
  • Development, transfer, and qualification of assays.
  • Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
  • Technical point of contact for Process Analytical Technologies (PAT).
  • Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), and work instructions.
  • Technical lead for characterization testing, ensuring testing conducted either internally or externally.
  • Serving as a key member during internal audits and external inspections/audits.
  • Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with an end-to-end product focus.

Qualification and Experience:

  • Demonstrated leadership and change management skills with a continuous improvement focus.
  • A self-starter and results-focused, with strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
  • Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science to drive decision making, impact assessments, and design of studies in a multi-disciplinary team environment.
  • With a Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, the successful candidate will ideally have a proven track record in delivering excellence.

Technical:

  • Experience with analytical testing in support of 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.
  • Significant amount of Analytical Chromatography experience, ideally with some Mass Spectrometry experience.
  • 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 organizations 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.
  • This role requires an experienced individual with a minimum of 6 years' (for MSc), 8 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.
  • Experience with assay development and qualification of biologics assays (HPLC-based, ELISA, etc). Familiarity with potency assays, including cell-based assays.
#J-18808-Ljbffr

  • Dublin, Dublin City, Ireland PSC Biotech Full time

    Job DescriptionAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    As a Senior Biopharmaceutical Specialist, you will play a crucial role in driving innovation and excellence in our organization.Your primary focus will be on serving as a subject matter expert in biologics analytics and characterization, providing technical input to teams and coaching associate staff.Key responsibilities include:Developing and implementing...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Life Science Recruitment is currently seeking a skilled Senior Biopharmaceutical Specialist to join our team in an exciting opportunity with a leading multinational based in Swords.This role is ideal for individuals looking to take on a challenging position in a dynamic industry, where they can utilize their technical expertise and leadership skills to drive...

  • Analytical Scientist

    5 hours ago


    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Overview: Life Science Recruitment is currently seeking a highly skilled Analytical Scientist to join our award-winning Pharmaceutical organization based in Dublin. This is an exciting opportunity for individuals looking to make a significant impact in the biopharmaceutical industry.About the Role: As a key member of our Quality Control team, you will be...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Join us at Life Science Recruitment as a Senior Equipment Specialist and play a vital role in ensuring the smooth operation of our facilities. As a key member of our engineering team, you will be responsible for coordinating the introduction of new equipment and processes.Key ResponsibilitiesCoordinating the introduction of new processes and...


  • Dublin, Dublin City, Ireland CPL Full time

    At CPL, we are seeking an experienced Analytical Method Specialist to join our team at our state-of-the-art site in Dublin, Grange Castle. This is a fixed-term contract role with hybrid working arrangements.About the Role:Manage external analytical method transfer and new product introduction projects, including mRNA products for rest of world markets and...


  • Dublin, Dublin City, Ireland Amazon Full time

    About the Role:We are seeking a highly skilled Data Analytics Specialist to join our team at Amazon. As a key member of our Business Intelligence group, you will be responsible for translating business questions and concerns into specific analytical questions that can be answered with available data using BI tools.The ideal candidate will have experience in...


  • Dublin, Dublin City, Ireland Life Science Consultants (LSC) Full time

    About the Opportunity:LSC invites applications for a Senior QC Associate Chemist position in a South Dublin based biopharmaceutical company.About the Company:LSC is a leading provider of contract services to the biopharmaceutical industry.We offer a range of services, including quality control and assurance.We are committed to providing high-quality services...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    About UsLife Science Recruitment is a specialist science recruitment agency, founded in 2007. We focus on the recruitment and selection of professionals for the pharmaceutical, biotechnology, and medical device sectors in Ireland and internationally.Our CultureWe offer a fun and creative working environment where you are given autonomy to work independently...


  • Dublin, Dublin City, Ireland Real Time Recruitment Full time

    Senior Analytics Consultant required for a key hire with a leading industry OrganisationYou will work closely with business stakeholders to identify challenges, uncover opportunities, and provide actionable insights. A key component of this role is stakeholder management, ensuring alignment between technical outputs and business goals.While a data science...


  • Dublin, Dublin City, Ireland FBD Consulting, LLC Full time

    Company description:FBD Holdings PLCJob description: Job OverviewReporting to the Senior Digital Manager, the Web Analytics Specialist will play a key role in managing and enhancing website analytics while driving data-driven decision-making across the business. This dynamic position offers a proactive professional the opportunity to lead advanced analytics...


  • Dublin, Dublin City, Ireland Brookdale Senior Living Full time

    Senior Support Specialist - Dublin - Brookdale Senior LivingBrookdale Senior Living Dublin2 days agoJob title: Senior Living CaregiverDescriptionAbout UsBrookdale Senior Living Dublin is committed to delivering exceptional care and service to our residents.We are seeking a compassionate Caregiver to play a critical role in enhancing the lives of our...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    We're looking for an accomplished Analytics and Insights Specialist to join our team at TN Ireland.About the Role:The Senior Analyst, Product Innovation is responsible for providing analytical support to drive innovation and growth. This involves analyzing data, research, and market insights to develop sustainable pipelines for new product ideas.Key...


  • Dublin, Dublin City, Ireland Sunrise Senior Living Full time

    Senior Care Specialist - Dublin - Sunrise Senior LivingSunrise Senior Living Dublin2 days agoJob title: Senior Care ProfessionalDescriptionWe are dedicated to providing high-quality care and services to our residents at Sunrise Senior Living. Our team is committed to creating a warm and welcoming environment that promotes independence, dignity, and...


  • Dublin, Dublin City, Ireland BioMarin International Limited Full time

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...


  • Dublin, Dublin City, Ireland Aldi Usa Full time

    About the RoleWe are seeking a highly skilled Data Analytics Specialist to join our team at ALDI USA. In this role, you will be responsible for designing and delivering analyses for all real estate-related departments via workflows and statistical modeling.Key Responsibilities:Aggregate data from various sources to construct streamlined data pipelines and...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    We are seeking a highly skilled Pharmaceutical Science Leader to join our team in an exciting opportunity with a leading multinational based in Swords.This role is ideal for individuals looking to take on a challenging position in a dynamic industry, where they can utilize their technical expertise and leadership skills to drive success.The successful...


  • Dublin, Dublin City, Ireland Irish Life Group Services Limited Full time

    Role OverviewThis Data Support Specialist position is an integral part of our Data Strategy team, responsible for delivering data solutions to stakeholders and ensuring decisions are driven by data for better business and customer outcomes.About UsWe are proud of our culture of developing and supporting our people's growth and professional development. Irish...


  • Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    About UsRecruitment By Aphex Group is a leading provider of innovative solutions for the recruitment needs of our clients.Job SummaryWe are seeking an experienced Analytical Project Specialist to join our team. As an Analytical Project Specialist, you will be responsible for delivering analytical projects that meet business needs.Key Responsibilities:Provide...


  • Dublin, Dublin City, Ireland BIOMARIN Full time

    Who We AreBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...