The individual will serve as a PAT subject matter expert on program teams and apply a diverse PAT toolkit such as (e.g., online UPLC, Raman, FTIR coupled with advanced chemometric methodologies) in support of early to late-stage programs. The selected individual will proactively advocate for the use of PAT to enable business outcomes by partnering across our Company's network with process, quality, and manufacturing teams to identify enabling opportunities.

This role will also be accountable for developing, optimizing, and executing on phase appropriate validation strategies for online/in-line/at-line methods to monitor and control drug substance and drug product quality attributes in the development space with the intent of enabling seamless transfers to the commercialization space. Additionally, the selected individual will be expected to maintain a strong internal and external network to proactively identify technologies while championing their evaluation and their successful incorporation to existing workflows.

Applicants must have effective communications skills (both oral and written), show scientific curiosity demonstrated through research and publications. As a member of our team, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines and vaccines of tomorrow.

Position Qualifications:

Education Minimum Requirements:

• Ph.D. in Chemistry or related field with a minimum of 4+ years of relevant experience OR a Masters degree with a minimum of 8+ years of experience

Required Experience and Skills:

• Knowledge of vaccine process development and pilot scale manufacturing
• Proficiency in the use of data-driven qualitative and quantitative chemometric model building approaches (MVDA)
• Experience in areas such as, continuous monitoring using process analytical tools, or lab automation/informatics.
• Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
• Demonstrated scientific ability through publications and presentations in scientific conferences.
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.
• Ability to learn new concepts in measurement sciences outside of core expertise and training and the application to problem solving is required
• Ability to work in a team environment with cross-functional interactions is essential
• Evidence of strong cross-functional collaboration in an industrial setting

Preferred Experience and Skills:

• Familiarity with late-stage CMC analytical deliverables including development and the successful execution of GMP validation protocols and tech transfers to commercial laboratories.
• Proficiency in the use of data-driven qualitative and quantitative chemometric model building approaches (MVDA)
• Experience in areas such as, continuous monitoring using process analytical tools, or lab automation/informatics.

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NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

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.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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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:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
Yes

Hazardous Material(s):
n/a

Job Posting End Date:
11/16/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R308981