Job Description

Responsible for USW supervision for the Biologics Support Operations (BSO) organization in the Media Buffer Preparation (MBP), Sterile Supply, Weigh and Dispense (W&D), and Warehouse areas within the Biologics Clinical Manufacturing and Technology pilot plant facility. The individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. This includes close collaboration with Process Development groups, Facility Engineering, RM/CM Release, Procurement, Manufacturing, Pharmaceutical R&D and outside vendors.

ACCOUNTABILITY

The incumbent will be accountable for the management of the staff within his/her team. She/he will help develop a high performing team based on requirements set out in the USW Collective Bargaining Agreement. They will also be responsible for resource planning, risk assessment strategies and budget management, as necessary.

DUTIES

• Compliance - Oversee operating procedures, facility, inventory, and equipment compliance, and support internal and external inspections.

• Continuous Improvement - Support new IT initiatives and execute continuous quality improvement projects within the BSO team.

• People Management - Lead a team of USW union staff, work collaboratively in a complex, matrix environment, and foster team productivity and cohesiveness.

• Some overtime (including weekends) will be required as well as carrying an on-call phone to support off-hour manufacturing.

QUALIFICATIONS:

Essential:

• BS/MS in Biological Sciences, Chemistry, or Engineering with a minimum of 3+ years of relevant experience.

• Experience working in a regulated environment in support of Good Manufacturing Practices (GMP) activities.

• Demonstrated ability to meet firm deadlines in support of product discovery, development and commercial filings for biopharmaceutical or vaccine products.

Preferred:

• Ability to work independently and in a team environment.

• Strong organizational, planning and communication skills.

• The individual should be highly motivated with the ability to work in a fast-paced setting.

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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".

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.

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Requisition ID:R330629