Associate Principal Scientist – Potency

Found in: beBee S IE - 4 weeks ago

Dunboyne, Ireland MSD Full time

Job Description

Join us at Dunboyne and be part of our innovative team at the cutting edge of biologics research. We are currently seeking an Associate Principal Scientist for our Biologics Analytical Research & Development department. In this lab-based role, you will be responsible for solving complex analytical problems related to technology transfer, new product introduction, and procedure optimization to support the clinical pipeline. 

Key Responsibilities: 

  • Lead the development, validation, implementation, troubleshooting, and transfer of analytical methods. 

  • Represent the Bioassay/PCR team for new product introductions at the network level. 

  • Ensure schedule adherence for the Bioassay/PCR team, including new product introduction and batch release testing. 

  • Collaborate with analytical and process teams to assess clinical and commercial drug substance. 

  • Provide guidance to process development based on analytical data interpretation. 

  • Review analytical testing of drug substance release, stability, and characterization under GMP/GDP. 

  • Analyze and optimize lab/business processes and implement new technologies and methodologies. 

  • Review and approve analytical methods, SOPs, and other documentation. 

  • Ensure compliance with internal company regulations regarding safety, health, and environmental protection. 

  • Oversee QC-related issues, investigations, and inspection readiness for the BioAssay/PCR lab. 

  • Coach and mentor analytical scientists to promote scientific excellence. 

  • Establish collaborations across sites for global alignment of data management practices. 

Requirements: 

  • Ph.D. in analytical chemistry, biochemistry, biology, or related field with a minimum of 5 years of experience OR M.S. with a minimum of 7 years of experience OR Bachelor's with a minimum of 12 years of experience in the Pharmaceutical Industry. 

  • In-depth knowledge of GMP regulations and experience in audit situations. 

  • Expertise in analytical validation/transfer requirements. 

  • Proficiency in Cell Based Assays, Immunoassays, PCR methods, and Softmax Pro. 

  • Strong understanding of Critical Quality Attributes, data analysis, statistics, and setting specifications. 

  • Experience with matrix management and leading through influence. 

  • Excellent organizational and multitasking skills, with strong oral and written communication abilities. 

  • Proven analytical aptitude, critical thinking skills, and ability to apply key concepts. 

  • Demonstrated ability to develop scientific excellence through mentorship and coaching. 

  • Strong Lean Six Sigma Methodology experience. 

  • Ability to work effectively in cross-functional interactions. 

Preferred Experience and Skills: 

  • Understanding of current manufacturing processes. 

  • Experience in the analysis of various biologic modalities. 

  • Understanding of protein degradation mechanisms and their link to analytical methodologies. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary 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.

So, 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:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID:R288066