Change Control - West Point, United States - Merck Sharp & Dohme

Merck Sharp & Dohme

Verified Company

West Point, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

The Large Molecule Analytical Validation (LMAV) team within Analytical Research & Development (AR&D) - our Research & Development Division is responsible for the strategic oversight and tactical operations of analytical method validation for commercialization of large molecules (Biologics and Vaccines).

This team is highly motivated, fast-paced and focused on the rapid advancement of our company's large molecule pipeline.

Primary Responsibilities:

Manage endtoend analytical change control activities associated with commercialization and ensure change control compliance with all regulatory expectations and global procedures.
Partnering with key stakeholders in Regulatory, Analytical, Technology, Supply Chain, Operations, and Quality to coordinate assessments and approval of analytical change controls.
Develop change strategy through creation of change plan and tasks and maintain endtoend oversight to drive progress and escalate where required.

Required Experience and Skills:

Experience and understanding of change control environment and systems
Work independently and within crossfunctional teams.
Effective organization to multitask and manage multiple projects
Strong collaborative and communication skills
Effective written and oral communication skills

Minimum education required:

BS degree required, concentrations in life sciences, engineering or related relevant discipline with 2+ years of relevant industry experience.

NOTICE FOR INTERNAL APPLICANTS

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.

To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

US and Puerto Rico Residents Only:
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.

All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

For more information about personal rights under the U.S.

Equal Opportunity Employment laws, visit:
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Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/26/2024

Job Posting End Date:
06/26/2024

Requisition ID:
R298934