Operations Supervisor (2nd shift) - Spray Drying and Oral Solid Dosage Turnaround

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.

• Learns equipment well enough to become a trainer

• Develops daily plan and assignments

• Facility alarm 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

• Bachelors 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 #EBRG #vetjobs #eligibleforerp PSCS

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 separation package, 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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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:

$91,600.00 - $144,100.00

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

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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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

pharmaceutical active ingredients

Job Posting End Date:

12/4/2024

*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.

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