Job Description

As part of Our Company's Manufacturing Division, within the Large Molecule Sciences and Technology (LMS&T) organization, the Large Molecule Tech Transfer (LMTT) department provides the technical process leadership in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. LMTT supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Job Description:

The Senior Scientist/Engineer will contribute to commercialization activities of late-stage pipeline and/or commercial manufacturing support for biologically derived drug substances (e.g., therapeutic proteins or vaccines). For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.

This person will be responsible for technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of generating new data and knowledge to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance processes. Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings, and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.

This person may have to manage large multifaceted projects as the leader of a cross-functional team. As an individual contributor, may be concerned with clearly identifiable elements or functions within a larger project team. May oversee and coordinate work performed by contractors.

This role may require working outside of core business hours to assist with lab studies and/or on-site activities related to tech transfer and manufacturing. GMP tasks include authoring, reviewing, and approving technical and regulatory documents.

Minimum Education & Experience Required:

• Bachelor's Degree in Engineering, Science or related field with a minimum of 5 years of relevant experience; or Master's degree with a minimum of 3 years of relevant experience; or Doctoral Degree (Ph.D.) with 0 years of experience.

Required Experience and skills:

• Experience in technology transfer

• Experience with on-the-floor GMP manufacturing support

• Experience with authoring, reviewing, and approving technical and regulatory documents

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.

Employee Status:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R328095