Associate Director, Process Engineering
Associate Director, Process Engineering
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$ 139600 - 219700
1 Vacancy
Job Description
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 supply manufacturing facility in Rahway New Jersey.
The Sterile Process Engineer role at the Associate Director level will leverage the individuals leadership technical and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is nearing the completion of its Performance Qualification and Process Simulation execution the selected candidate will lead and contribute to the launch and regulatory certification of the facility concluding startup and operational readiness activities.
Once the facility is operational this role will support the pipelines most technically complex formulation and process development through process tech transfer scale-up activities quality investigations change management and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic planning and business savviness as they collaborate with the formulation scientists engineers operations staff 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 Companys pipeline. Leadership of tech transfer of these processes to the operations group will require the individual to leverage Decision Making and Execution Excellence skills to be successful. Off-shift (2nd) work will intermittently be expected as a part of the role to support operations areas. The role is on-site based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).
Education Minimum Requirements:
Bachelors degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 7 years relevant experience
Masters degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 5 years of relevant experience or a
PhD degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field.
Required Experience and Skills:
Excellent interpersonal and communication skills both verbal and written.
Expertise in drug product aseptic processing equipment and sterile technique.
Experience in leading quality investigations and change management.
Familiarity with United States 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 GXP documents.
Experience with quality systems.
Excellent organizational skills.
Desire and willingness to learn contribute and lead.
Track-record of independent problem-solving.
Preferred Experience and Skills:
Experience with sterile GMP facility startup.
Knowledge of Investigational drug regulatory requirements.
Understanding of Clinical Supply Chain Operations.
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.
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 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:
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 anothers thinking and approach problems collectively.
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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 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
$139600.00 - $219700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Applied Engineering Applied Engineering Chemical Engineering Chemistry Clinical Operations Customer-Focused Data-Driven Decision Making Drug Product Development Estimation and Planning GMP Compliance Management Process Manufacturing Quality Control Medical Supply Management Medicinal Chemistry Pharmaceutical Process Development Pharmaceutical Sciences Phytochemistry Process Control Automation Process Optimization Process Simulation Product Formulation Safety Compliance Standard Operating Procedure (SOP) Development Sterile Procedures Strategic Management 3 morePreferred Skills:
Job Posting End Date:
08/1/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
