Job Description

As part of Our Company's Manufacturing Division, within the Large Molecule Science and Technology (LMS&T) organization, the Bioprocess Separation Sciences (BSS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and commercial manufacturing purification processes for biologics (therapeutic proteins) and vaccines. BSS supports a various combination of commercialization activities for pipeline and commercial program support, including process development and characterization laboratory experiment design and execution, technology transfer to internal and external manufacturing sites, process validation, manufacturing investigations and trend analysis, process enhancements, next generation process development, and authoring of regulatory submissions.

Under the general scientific and administrative department direction and working in conjunction with internal and external program partners, this individual will support late stage and commercial program purification activities within BSS.

Scope includes:

• Participates in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation with line-of-sight for licensure and commercialization.

• Responsible for laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.

• Provides technical leadership in the interpretations of trends observed in commercial process monitoring and for further technical investigations and process improvement changes.

• Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including upstream, analytical, and secondary manufacturing and GMP site readiness.

• Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams.

• Authors required regulatory and technical documentation. Ensures that processes are developed and documented according to Our Company's standard practices.

Education Minimum Requirement:

• Degree in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with number of years in related field: 10 years with BS, 8 years with MS, or 4 years with PhD.

Required Experience and Skills:

• Technical expertise in purification of biological and/or vaccine molecules, including laboratory models for chromatography and/or filtration systems.

• Experience with technology transfer and/or scale-up of processes to pilot and manufacturing scales for biologics and/or vaccine manufacture.

• Excellent oral and written communication skills. Ability to effectively articulate understanding of purification process science, to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.

Preferred Experience and Skills:

• High-throughput purification technology experience, including Robocolumn purification using TECAN.

• Deep technical knowledge of harvest, preparative chromatography, tangential flow filtration, and/or normal flow filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations.

• Technical operations experience in the manufacture of biological and/or vaccine molecules at the pilot or commercial scale.

• Prior experience in late-stage process development, process characterization, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and working with external contract organization for development and or manufacturing.

• Working knowledge of statistical methods for DOE design and data analysis (JMP or Design Expert software).

• Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics and/or vaccine processes.

• Working understanding of analytical methods to characterize biologics and/or vaccines and cGMP US/EU regulatory requirements.

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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

Search Firm Representatives Please Read Carefully
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:R322451