Job Description

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The process engineer role at the Principal Scientist level will serve as a leader in the FLEx sterile GMP facility. 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 selected candidate is expected to build and develop a team of process engineers and foster a culture of collaboration, learning and innovation. He/She 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 Companys pipeline. Once the facility is up and running, this role will support facility operations, formulation and process development activities, quality investigation and change management, author current Good Practice documentation and manage/lead scientists and contractors. The role is based in New Jersey and reports to the Director of the FLEx GMP facility in Pharmaceutical Operations and Clinical Supply.

Education Minimum Requirements:

* Bachelors degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 15 years' relevant experience, or a Masters degree with 12 years of relevant experience, or a PhD degree with 10 years of relevant experience.

Required Experience and Skills:

* Extensive experience in managing GMP clinical supply facility.

* Experience with GMP facility start-up.

* Experience with managing direct reports or matrix teams.

* Extensive experience with both sterile and oral product development and manufacturing; extensive knowledge of drug product aseptic processing, equipment and sterile technique.

* Experience with Commissioning, Qualification and Validation.

* Experience in leading and supporting quality investigations and change management.

* Familiarity with U.S. and European Union GMP and Safety compliance regulations.

* Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.

* Ability to prepare Standard Operating Procedures (SOP) and current Good Practices documents.

* Experience with quality systems.

* Effective interpersonal and communication skills, both verbal and written.

* Excellent organizational skills to multi-task.

* Desire and willingness to learn, contribute and lead.

* Track-record of independent problem-solving.

Preferred Experience and Skills:

* Knowledge of investigational drug regulatory requirements.

* Understanding of Clinical Supply Chain Operations.

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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

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.

PHARMSCI

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R100181