Job Description

Seeking candidates for an Associate Specialist position in the company's Research Laboratories (Research Division) Biologics Pilot Plant (BPP) supporting the Biologics Support Operations (BSO) Front-Line Managers. The candidate will work under the direction of a front-line manager in a dynamic environment, supporting compliance and operations objectives in aid of multiple pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. Candidate will specifically support areas focusing on media and buffer manufacture, raw material weight and dispense, sterile tubing assembly and packaging, and GMP cleaning activities.

Tasks:

Candidate will participate in a range of activities including, but not limited to:

• Support safety, compliance, and GMP initiatives

• Prepare, Review, and update GMP Documentation (e.g., Standard Operating Procedures)

• Work with team members in identification and implementation of continuous improvement initiatives and actions plans

• Data entry, log management, and batch record reviews

• Under the direction of front-line managers, the candidate will help to motivate others, ensure performance, coordinate tasks, and support effective administration of personnel policies and procedures

• Participate in investigations and change management activities

• This is a developmental role with an opportunity to build a foundation into a front-line manager position.

Education:

• BS/BA in Biological Sciences, Chemistry, Engineering or related.

Experience/Skills:

• Comprehension of the regulatory guidelines governing GMP manufacture is important. The candidate will work in a team atmosphere in close partnership with (but not limited to) raw material release teams, facility operations, equipment engineering, process operations, safety, our Manufacturing Division Partners, and quality groups.

Qualifications:

• Work both independently and in a team setting

• Demonstrated ability to manage multiple tasks and priorities

• Effective problem-solving skills

• Effective technical communication skills

• Good comprehension of Microsoft Office Applications, including SharePoint and Power Platform Tools.

• Some overtime (including weekends) and occasional second shift work may be necessary. Carrying an on-call phone to support off-hour manufacturing will be required.

Preferred:

• Knowledge of SAP

• Knowledge of current GMP regulations

• Has worked within a Union Environment

• Has worked in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R334612