Associate Scientist, Process Analytical Technology (PAT) Center of Excellence Job

Associate Scientist, Process Analytical Technology (PAT) Center of Excellence-CHE005491

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

As a member of the Merck Process Analytical Technology (PAT) Center of Excellence, the successful candidate will be responsible for PAT implementations in Rahway by partnering with MMD Pharmaceutical Commercialization Technology and MRL Pharm Sciences. Additionally, the candidate will have the unique opportunity to lead PAT activities throughout a new drug product’s lifecycle, from early development to regulatory filing(s) and launch.

Specific responsibilities include:

- Serve as lead for PAT equipment compliance, laboratory chemical safety lead and ELN Steward
- Utilize the PAT tools to enable drug product quality by design by employing in-, on-, and/or at-line analytical measurement systems, design of experiments, chemometrics/multivariate statistics, and process control
- Support integration of PAT into new drug product manufacturing platforms such as continuous manufacturing, specifically in Rahway in miniature Continuous Manufacturing Skids
- As part of the team, support continuous manufacturing technology development (TDT) team activities. In the near term will focus on understanding shear differences in CM vs batch processes and its impact to downstream critical quality attributes.
- Manage Drug Product PAT Laboratory infrastructure
- Develop expertise in regulatory guidance applicable to PAT
- Support technology transfers including training technical MMD operations in use of PAT method(s)
- Multivariate modeling for real-time prediction of critical quality attribute(s) and for process control

Qualifications

Education:

- BS or MS in Chemistry/Chemical Engineering/Solid State Physics/Material Science and Engineering or related discipline with good academic record

Required:

- BS or MS in one of these fields, Chemistry, Physics, Material Science & Engineering, Chemical Engineering, Mechanical Engineering or Electrical Engineering.

Preferred:

- Familiarity with the general analytical laboratory practices, instrumentation and use of PAT tools, e.g. process analyzers and multivariate statistics for experimental design and data analysis
- Interest in conducting/managing overall laboratory compliance including equipment qualification and validation
- Understanding of regulatory requirements for drug product manufacture
- Demonstration of the following:
- Prioritizes activities and work based on the greatest potential for positive impact on the customer and patient
- Systematic, timely, and appropriately inclusive decision making
- Makes time in schedule for development activities, e.g. utilizes opportunities to learn new skills, acquire new knowledge
- Persistence and resilience in the face of obstacles and barriers

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Chemistry

Job Title:Assoc. Scientist, Chemistry

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Laboratory chemicals.

Company Trade Name:Merck