Associate Scientist, FLEx Process Engineer

Job title: Associate Scientist, FLEx Process Engineer

Company: Merck Sharp & Dohme

Job description: Job Description

The Formulation, Laboratory, Experimentation Center (FLEx) is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The process engineer role at the Associate Scientist level will serve support FLEx facility in either the sterile or oral solid dose modality. As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, regulatory certification, as well as other workstreams’ critical activities to enable facility startup. The process engineer will help foster a culture of collaboration, learning and innovation by seeking to learn and understand the core business and technologies.

The successful candidate will collaborate closely with the formulators, engineers, Quality reps, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company’s pipeline. The candidate should also have an affinity for hands-on problem solving on the shop floor. Once the facility is up and running, this role will support facility operations, formulation and process development activities, quality investigation and change management and author cGMP documentation. A large part of the role will surround adapting equipment and facility capability to meet pipeline requirements through innovation, new technology and process improvements. The role is based in New Jersey and reports to the Director of the FLEx Good Manufacturing Practice facility in Pharmaceutical Operations and Clinical Supply.

Education Minimum Requirement:

B. Sc. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field.

Required Experience and Skills:

Ability to prepare cGXP documents.

Effective interpersonal and communication skills, both verbal and written.

Desire and willingness to learn, contribute and lead.

Track-record of independent problem-solving.

Ability to work effectively with team-members of diverse skill sets and backgrounds.

Desired Experience and Skills:

Experience with new GMP facility startup.

Knowledge of Investigational drug regulatory requirements.

Experience with Commissioning, Qualification and Validation.

Experience with quality systems.

Familiarity with US and EU GMP and Safety compliance regulations.

Knowledge of SAP, ERP or MES systems.

Knowledge of drug product or drug substance processing.

Organizational skills to handle multiple priorities.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with 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.

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1

Expected salary:

Location: Rahway, NJ

Job date: Sat, 17 Jul 2021 00:11:26 GMT


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