Manager, Operations (2nd Shift)
Apply NowCompany: Merck & Co, Inc
Location: Rahway, NJ 07065
Description:
Job Description
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile formulations, typically oral solid dosage though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility supporting our research division and on-site project development teams.
The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an evening shift supervisor to focus on spray drying production runs as well as cleaning and turnaround activities. This will be a new shift. The successful candidate would stand-up and manage a team of 3 or more operations staff. This includes daily assignments, helping troubleshoot issues, improving the facility through process improvement, learning the equipment, and participating in production activities.
We are looking for a candidate with previous spray drying experience who is willing to work alongside operations staff to execute on activities each evening. The evening shift will be mostly cleaning and turnaround (assembly/disassembly) so a good mechanical understanding of process equipment will be required. While most batch production will occur on days, on occasion spray drying runs may require continuing into the evening, and the 2nd shift team would all be trained for execution on this production activity.
Strong experience in working with Good Documentation Practices (GDP) is required, as the successful candidate will be a reviewer and approver. Regular feedback and coaching is a part of this position as it will be based on the shop-floor. Experience with electronic batch records and documentation is a plus.
This position is 100% on-site and evening (2nd) shift. This position will start on days for an initial period of time for training and onboarding before the team flips to evening shift. Occasion weeks on 'days assignment' may occur to facilitate training needs throughout a given year.
Requirements:
Preferred requirements:
#MSJR #eligibleforerp
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 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 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:
$94,300.00 - $148,500.00
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
04/23/2025
*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.
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile formulations, typically oral solid dosage though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility supporting our research division and on-site project development teams.
The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an evening shift supervisor to focus on spray drying production runs as well as cleaning and turnaround activities. This will be a new shift. The successful candidate would stand-up and manage a team of 3 or more operations staff. This includes daily assignments, helping troubleshoot issues, improving the facility through process improvement, learning the equipment, and participating in production activities.
We are looking for a candidate with previous spray drying experience who is willing to work alongside operations staff to execute on activities each evening. The evening shift will be mostly cleaning and turnaround (assembly/disassembly) so a good mechanical understanding of process equipment will be required. While most batch production will occur on days, on occasion spray drying runs may require continuing into the evening, and the 2nd shift team would all be trained for execution on this production activity.
Strong experience in working with Good Documentation Practices (GDP) is required, as the successful candidate will be a reviewer and approver. Regular feedback and coaching is a part of this position as it will be based on the shop-floor. Experience with electronic batch records and documentation is a plus.
This position is 100% on-site and evening (2nd) shift. This position will start on days for an initial period of time for training and onboarding before the team flips to evening shift. Occasion weeks on 'days assignment' may occur to facilitate training needs throughout a given year.
- Learns equipment well enough to become a trainer
- Develops daily plan and assignments
- Facility alarms first responder and early troubleshooting
- Coordinates with Mechanical team for area/equipment availability
- Post-reviews batch records and cleaning records for GDP completion
- Reviews logs
- Manages cleaning planning, documentation, turnaround, samples, ARL/VRL
- Coordinates water sampling, cleaning, PPE requests
- Coordinates equipment moving
- Direct manager of operating staff including development of team
- People management, issue resolution, and coaching
- Facilitates area access requests
- Functional focused management
- Manages process locks
- Hot work/declassification permit management with mechanical team
- Follows the daily operations
Requirements:
- At least 3 years of experience managing a team in a pharmaceutical or regulated (e.g. food) GMP production area
- High school diploma + At least 7 years of experience in pharmaceutical production OR
- Bachelor's Degree in a relevant field, or equivalent + 4 years of experience in pharmaceutical production
Preferred requirements:
- Oral solid dosage experience
- Spray drying experience
- Experience managing documentation
- Assignments of team
- Development and training of team
- Issue resolution and coaching
- Partnership with safety and mechanical team members
#MSJR #eligibleforerp
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 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 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:
$94,300.00 - $148,500.00
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
04/23/2025
*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.