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Associate Principal Scientist, Analytical Program Lead - Hybrid, Dublin

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

Description

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

Associate Principal Scientist, Analytical Program Lead - Hybrid

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locations

IRL - Meath - Dunboyne

time type

Full time

posted on

Posted Yesterday

job requisition id

R268194

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

professional,

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

programme

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

commercial

-

facing

in

the areas of

:
monoclonal

other complex therapeutic proteins

vaccines in our large molecule portfolio

What 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 tools

Maintain 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 Ph D 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 (c GMP) 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

:
M

anaging therapeutic product analytical programs and experience in

a quality

control or

an analytical

development organization.

F

amiliarity with typical analytical techniques used for large molecule batch release

,

stability

, and

characterization

testing

.

E

xperience using project management,

validation

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

Power BI

,

Trackwise

)

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.
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.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
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.

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Job details:

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

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