Job Description

Seeking candidates for a Senior Specialist position within our company's research laboratories Biologics Pilot Plant Process Operations Team. This individual will provide downstream technical guidance on pilot-scale campaigns for the Good Manufacturing Practice manufacture of bulk clinical supplies, leading technical process fit on downstream unit operations, and contributing to manufacturing activities in the other disciplines as needed. Strong comprehension of regulatory guidelines governing Good Manufacturing Practice manufacture is essential. The candidate will work in matrixed teams in close partnership with process and analytical development groups, facility engineering, Quality, Good Manufacturing Practice compliance, and safety groups. Candidate will participate in a range of process readiness activities including, but not limited to, equipment specification, equipment start-up, campaign document preparation/review, process fit within the Biologics Pilot Plant suites, technical document preparation, and planning/execution/close-out of Good Manufacturing Practice batches. Some overtime, including weekends and occasional second and third shift work, will be required during operations. Assignments include elements of preparation, execution, and closeout of a Good Manufacturing Practice campaign.

Primary Responsibilities:

• Designing and performing downstream operations such as normal flow filtration, tangential flow filtration, homogenization, lyophilization, chromatography, and centrifugation.

• Preparing critical technical documents for process readiness (e.g., Standard Operating Procedures, batch records).

• Evaluating and integrating innovative technology/process equipment fit.

• Developing equipment specifications & participating in start-up activities.

• Working in a multi-disciplinary project team environment.

• Troubleshooting downstream process unit operations.

• Leading and supporting cross-functional teams with ability to objectively resolve problems and issues.

Education Minimum Requirements:

• Bachelor's degree in Chemical Engineering or Biological Sciences with minimum 5 years of relevant experience or a master's degree with minimum 3 years of relevant experience.

Required Experience and Skills:

• Good Manufacturing Practice manufacturing of biologics, or vaccines, and/or process development activities.

• Subject matter expertise in one purification unit operation

• Strong teamwork and collaboration

• Extensive knowledge of cGMP, Quality Systems, and safety for operations

• Highly self-motivated with the ability to work in a fast-paced and dynamic setting with high adaptability to change.

Preferred Experience and Skills:

• Excellent organizational, problem-solving, and project management skills

• Strong technical background in large molecule operations

• Experience leading teams in a matrixed organization.

• Demonstration of Decision Making, Execution Excellence, and Ownership and Accountability Leadership Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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.

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Relocation:

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Flexible Work Arrangements:

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Requisition ID:R332521