Associate Principal Scientist, Analytical Program Lead - Hybrid, Dublin

Last update 2024-04-14
Expires 2024-05-14
ID #2085193707
Associate Principal Scientist, Analytical Program Lead - Hybrid, Dublin
Ireland, Dublin, Dublin,
Modified March 24, 2024


Associate Principal Scientist, Analytical Program Lead - Hybrid page is loaded

Associate Principal Scientist, Analytical Program Lead - Hybrid



IRL - Meath - Dunboyne

time type

Full time

posted on

Posted Yesterday

job requisition id


Job Description
Analytical Research and Development is seeking an experienced analytical program management


to join our Large Molecule Analytical Validation team atour 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


-specific analytical strategy and management of analytical timelines and deliverables for





the areas of


other complex therapeutic proteins

vaccines in our large molecule portfolio

What you will

Working with a multi-functional, diverse team to deliver results


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


of Quality by Design tools

Maintain and communicate timelines using project management tools.


and communicate risks, issues, and opportunities proactively and develop mitigation strategies


overcome challenges



analytical technical

experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections.

Lead or


in the development and refinement of above-program strategic plans and


, 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,


or related field with 12 years of relevant experience, or MSc with 7 years of relevant experience or Ph D with 4 years of relevant experience.

Validation and transfer oversight experience


Project management experience tracking,


and communicating


delivery of milestones.

Ability to work independently and within cross-functional teams, in-person and remotely.

Effective communicator,


and partner

both internally and externally


Strong knowledge and experience in application of current Good Manufacturing Practices (c GMP) to analytical activities within a quality management system and with health authority submissions and interactions.

Willing to travel up to 25%





anaging therapeutic product analytical programs and experience in

a quality

control or

an analytical

development organization.


amiliarity with typical analytical techniques used for large molecule batch release



, and





xperience using project management,


and Electronic Document Management Systems (e.g., scheduling tools,

Power BI




Current Employees apply HERE
Current Contingent Workers apply HERE

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


hybrid working model
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:

VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Valid Driving License:
Hazardous Material(s):

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Associate principal scientist, analytical program lead - hybrid

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