Job Description
The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the early phase and commercial formulation development and GMP clinical supply manufacture of our Company’s drug product pipeline. The FLEx Sterile Process Engineer at the Associate Director level serves as a technical subject matter expert in process development, equipment and facility optimization, and new capabilities across the sterile development facility. They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of a diverse portfolio of sterile drug product formulations using the capabilities and facilities of the FLEx Center. They will be responsible for the technical mentorship of process engineering colleagues who will partner with formulators and engineers to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Sterile Product Development, Quality, Regulatory Affairs, Engineering, and Analytical will be required to ensure effective process development in support of clinical development.
The successful candidate will drive continuous improvement to realize the vision of the FLEx Center as a learning facility. They will serve as a role model for the culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product process development experience, an affinity for hands-on problem solving, and excellent leadership and communication skills.
The role is based in New Jersey and reports to the FLEx Sterile Process Engineering Lead in Pharmaceutical Operations & Clinical Supply.
Primary Responsibilities:
Serve as a technical expert and mentor to a team of process engineers, tasked with becoming equipment and facility subject matter experts themselves.
Provide trouble shooting support on the shop floor
Drive internal capability development by evaluating new drug product technologies and deploying new technologies to develop pipeline assets
Collaborate effectively within and across functional areas. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.
Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others
Participate in external and internal audits, tours, and inspections
Execute investigations, as needed
Lead and drive a culture of continuous improvement across this facility
Education Minimum Requirement:
Ph.D. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum 4 years of relevant experience or B.S. or M.S. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum 7 years of relevant experience.
Required Experience and Skills:
Knowledge of sterile drug product processing
Experience with GMP manufacturing
Effective interpersonal and communication skills, both verbal and written
Excellent organizational skills to handle multiple priorities
Track record of independent problem-solving
Preferred Experience and Skills:
Experience with GMP facility operations
Experience in leading and supporting quality investigations and change management
Experience with quality systems
Familiarity with US and EU GMP and Safety compliance regulations
Experience with SAP, ERP or MES systems
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 separationpackage, 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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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$135,500.00 - $213,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/1/2024
*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.
