Job Description

As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial program activities within CCFS. The individual will be responsible for leading a team to support commercialization activities of pipeline and/ or post-market commercial manufacturing vaccines and biologics. 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.

In this role, the successful candidate will be responsible to

• Coordinate project planning, resourcing, staffing, supply and subcontract management, progress reporting, troubleshooting and people management.
• Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
• Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and regulatory filings for the company's pipeline.
• Monitors performance and recommends schedule changes, cost adjustments or resource additions.
• Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.
• Provides timely and accurate information and status updates to project sponsors and management.
• Participates in budget development and evaluating how project plan changes impact cost and schedule.
• Will oversee and coordinate work performed by outside contractors.
• May be responsible for managing large multifaceted projects as the leader of a cross-functional team.

Minimum Education Requirements and Experience:

• Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of industry experience in cell culture and fermentation process development; OR
• Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of industry experience in cell culture and fermentation process development; OR
• Ph. D in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of industry experience in cell culture and fermentation process development

Required Skills and Experience:

• Mechanical background and hands-on experience with upstream Large Molecule processes.
• Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.)
• Understanding of bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors and bioreactor scale-up principles from laboratory to large scale
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization
• Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions

Preferred Experience and Skills

• Experience with cell culture process development for both biologics and vaccines.
• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control
• Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)
• Knowledge of biologics CMC development cycle and PAI.

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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:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R323205