Senior Scientist, Biologics

Job Description

A fantastic opportunity has arisen for a Senior Scientist, Biologics & Vaccines Formula based at our site in Biotech (Swords), Co. Dublin. Global Quality Large Molecule Analytical Sciences (GQ- LMAS), in our Manufacturing Division, is accountable for the commercialization of large molecule, vaccines and biologics, analytical techniques from Phase III through launch and transfer to supply.  This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. This position will involve oversight of late-stage method development, validation, and life-cycle management of methods but mainly global method transfer activities.

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

• Lead method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.
• Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our Company network and external partners to ensure the successful commercialization of assays promoting our pipeline programs.
• Involvement in management of deviations, troubleshooting and optimization of analytical methods during method transfer activities.
• Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology.
• Assay Life Cycle activities across various large molecule franchises and analytical platforms
• Promote various vaccine and/or biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation.
• Direct strategic initiatives within departmental and cross-functional teams representing Global Quality Large Molecule Analytical Sciences (GQ- LMAS).
• Manage global registration and test on importation (TOI) activities.
• Be available to travel when required, approximately 10-15% per year, to other global sites/locations.

What skills you will need: 

• Bachelor’s degree in biology, chemistry, biochemistry, or related science with six years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or
• Master’s degree in biology, chemistry, biochemistry, or related science with four years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or
• PhD in biology, chemistry, biochemistry, or related science with one year of relevant industry knowledge in systematic development, validation, and/or quality control (QC)
• Knowledge of ICH, USP and other compendial chapters required for method transfer and validation.
• Knowledge with late-stage method development, validation, and transfer
• Minimum two years working knowledge in a current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics)
• Development and management of project timelines and deliverables
• Participation in cross-functional project teams
• Authoring and review of technical documents
• Ability to work objectively and within a cross-functional team.
• Technical, verbal, and written communications, stakeholder management, and teamwork skills
• Self-motivated with a positive attitude and proven performance record
• Knowledge with drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics
• Strong organizational and project management skills
• Ability to effectively identify and express risks.

Desirable Experience:

• Deviation management and change control processes
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ)
• Global launch or supply experiences
• Supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)
• Continuous improvement or lean six sigma methodology

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 our hybrid working model 

So, if you are ready to invent solutions to meet unmet healthcare needs, 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:R287759