Associate Principal Scientist, Analytical Program Lead - Hybrid

MSD

  • Dunboyne, Co Meath
  • Permanent
  • Full-time
  • 21 days ago
Job DescriptionAnalytical Research and Development is seeking an experienced analytical program management professional, to join our Large Molecule Analytical Validation team at our new State of the Art single use Multiproduct Biotech facility at Dunboyne Biologics.The primary responsibility is to lead and oversee the development and delivery of a programme-specific analytical strategy and management of analytical timelines and deliverables for commercial-facing in the areas of:monoclonalother complex therapeutic proteinsvaccines in our large molecule portfolioWhat you will do:Working with a multi-functional, diverse team to deliver results on schedule, you will bring your energy, knowledge, and innovation to:Manage and serve as primary point of contact for analytical milestones to management and key stakeholders (program Development and Commercialization Teams, Global Quality, large molecule analytical development organizations and CMC Regulatory Affairs).Supports the development of an integrated control strategy through the utilization of Quality by Design toolsMaintain and communicate timelines using project management tools.Identify and communicate risks, issues, and opportunities proactively and develop mitigation strategies to overcome challenges.Support analytical technical experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections.Lead or assist in the development and refinement of above-program strategic plans and objectives, for example reference standard, specifications, critical reagents, etc.Represent the analytical organization on governance teams.What skills you will need:To excel in this role, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.BSc degree in Chemistry, Biochemistry, Engineering, Pharmaceuticals or related field with 12 years of relevant experience, or MSc with 7 years of relevant experience or PhD with 4 years of relevant experience.Validation and transfer oversight experience .Project management experience tracking, supporting and communicating timely delivery of milestones.Ability to work independently and within cross-functional teams, in-person and remotely.Effective communicator, influencer and partner both internally and externally.Strong knowledge and experience in application of current Good Manufacturing Practices (cGMP) to analytical activities within a quality management system and with health authority submissions and interactions.Willing to travel up to 25% domestically/internationally.Preferred experience:Managing therapeutic product analytical programs and experience in a quality control or an analytical development organization.Familiarity with typical analytical techniques used for large molecule batch release, stability, and characterization testing.Experience using project management, validation and Electronic Document Management Systems (e.g., scheduling tools, PowerBI, Trackwise)Current Employees applyCurrent Contingent Workers applySecondary Language(s) Job Description: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.As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about ourSo, if you are ready to:Invent solutions to meet unmet healthcare needs, please apply today.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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):

MSD

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