Assistant Production Lead Early Development Center (Onsite)
Assistant Production Lead Early Development Center (Onsite)
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
Location:Rahway New Jersey
Department:Pharmaceutical Operations and Clinical Supply
Position Overview
Join us at the forefront of pharmaceutical innovation! The Formulation Laboratory & Experimentation Early Development Center (FLEx EDC) is a state-of-the-art Non-Sterile predominately Oral Solid Dose (OSD) Drug Product development and GMP clinical manufacturing facility dedicated to advancing small molecule pipeline assets. We are seeking an Assistant Production Lead who is passionate about optimizing processes and driving efficiency while instilling a culture grounded in safety & compliance.
Key Responsibilities
Collaborate with formulators engineers site partners and other stakeholders to identify and deliver opportunities for process enhancements that drive operational excellence.
Shape and refine processes for scheduling & schedule requests; incorporate the use of digital tools to streamline scheduling where possible
Manage scheduling requests for maintenance & calibration by facilities & engineering teams to ensure minimal impact to clinical & development operations
Ensure schedule adherence for both GMP & Non-GMP development areas
Manage daily Tier meetings and ensure cross functional team is following up on assigned actions
Serve as the liaison for EDC Operations at non-sterile production tiers confirming that clinical & development batches remain on track; escalate potential issues appropriately to ensure timely resolution
Perform walkthroughs for both safety and compliance to ensure our Companys standards are met while maintaining audit readiness
Lead CAPA & Deviation management to ensure timely closure of any observations
Author review and approve GMP procedures and documentation with an emphasis on operations SOPs and Work Instructions
Facilitate the management of changes to the development & production areas; execute periodic reviews and support Quality Management System (QMS) activities
Qualifications
Bachelors Degree in Engineering or Science plus a minimum of 5 years of related Drug Product/Oral Solid Dose (OSD) manufacturing & development experience.
Familiarity with Quality Regulatory cGMP Safety & Environmental Policies and Procedures
Strong technical writing skills to prepare Standard Operating Procedures (SOP) and cGXP documents
Exceptional organizational and analytical abilities with a keen eye for detail
Strong computer skills with preference for SAP experience
Strong communication and interpersonal skills to foster collaboration across diverse teams
A proactive mindset with a knack for identifying inefficiencies and proposing innovative solutions; Lean Six Sigma certification preferred
PSCS
#eligibleforERP
Required Skills:
Analytical Method Development Analytical Method Development Analytical Thinking Calibration Management Software Calibration of Equipment Collaborative Communications Communication Cross-Functional Teamwork Deviation Management Drug Development Facility Design GMP Compliance Interpersonal Relationships Lean Six Sigma (LSS) Management Process Manufacturing Manufacturing Process Validation Operational Excellence Personal Initiative Process Optimization Product Testing Project Team Leadership Quality Management Quality Management System Auditing Self-Management 3 morePreferred 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.
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.
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 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
$114700.00 - $180500.00This 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:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
10/8/2025*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.
Employment Type
Full-Time
