Job Description
The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). A large-scale capital project, known as the FLEx Sterile Expansion project, is currently underway.
The FLEx Sterile Expansion project is nearing completion of its detailed design phase and has begun construction and commissioning and qualification of the long lead time process equipment. Upon its completion, the expansion project will more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and various supporting infrastructure and utilities.
The Technical Operations – New Production Introduction (NPI) role at the Associate Specialist level will make significant contributions in technical transfer, manufacturing science and technology, startup and operational readiness activities and deliverables related to the expansion project. The successful candidate will play a crucial role in ensuring flawless execution of startup and operational readiness deliverables of the FLEx Sterile Expansion project, particularly those requiring subject matter expertise of from the voice of the process and business. This individual will collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline.
Once the facility is operational, this role will support the formulation, process development, and scale-up activities, quality investigations and change management, standard operating procedures and protocols in support of sterile clinical drug product operations.
Education Minimum Requirements
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field by May 2026
Required Experience And Skills
- Familiarity with United States and European Union GMP and Safety compliance regulations.
- Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
- 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
- Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
- Knowledge of drug product aseptic processing, equipment and sterile technique.
- Experience in leading and supporting quality investigations and change management.
- Experience with sterile GMP facility startup.
- Experience with Commissioning, Qualification and Validation.
- Knowledge of Investigational drug regulatory requirements.
- Understanding of Clinical Supply Chain Operations.
#eligibleforERP
#PSCS
FLEx2026
Required Skills
Accountability, Accountability, Adaptability, Antibody Drug Conjugates (ADC), Applied Mathematics, Capital Projects, Chemical Engineering Fundamentals, Chemical Plant Operations, Clinical Quality Management, Clinical Trials Operations, Communication, Data Analysis, Engineering Standards, Estimation and Planning, Field Failure Analysis, GMP Compliance, Management Process, Manufacturing Scale-Up, Medical Supply Management, Oral Solid Dosage, Pharmaceutical Quality Assurance, Process Optimization, Process Scale Up, Professional Engineering, Quality Management {+ 5 more}
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
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 click here if you need an accommodation during the application or hiring process.
Requirements
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
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”.
The salary range for this role is
$71,900.00 - $113,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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:
No relocation
VISA Sponsorship
No
Travel Requirements
10%
Flexible Work Arrangements
Not Applicable
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
02/9/2026
- 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:R381194
