Job Description

As part of Our Company's Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for Vaccines, Biologics and sterile pharmaceutical products. It is the divisions leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing science, engineering and knowledge required for today's innovative and accelerated commercialization of novel Vaccines, Biologics, pharmaceutical products and combination products.

The Scientist is a drug product commercialization Scientist/Engineer, responsible for these key activities within the Sterile Drug Product Commercialization department. Our engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our scientists/engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

This position may require travel up to 10%; Must be able to travel for this position.

Responsibilities for this position include but are not limited to the following:

• Serves on cross functional drug product (DP) working groups and supports DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection (PAI) readiness, approval, launch and post-launch support.

• Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.

• Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.

• Contributes to development of fit-for-purpose scale-down models. Establishes and validates platform engineering and scientific models for sterile product and process commercialization.

• Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in-process controls.

• Contributes to establish and foster a culture of high performance, out of the box thinking innovation and learning, empowerment, diversity and inclusion.

Minimum Education Requirements:

• B.S in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Bio-Engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2 years of relevant experience; or

• Master's degree in chemical engineering, Bio-Engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field.

Required Experience and Skills:

• Relevant academic, internship, co-op, or professional experience in a laboratory setting.

• Excellent oral and written communication skills.

• Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail

Preferred Experience and Skills:

• Technical experience in large molecules drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial scale, with a clear knowledge of specific unit operations. Ability to apply knowledge of drug development processes to provide appropriate manufacturing and engineering oversight based on existing processes.

• Demonstrated capability to design and implement experimental plans to determine root causes and generate innovative solutions to problems.

• Knowledge of combination product development.

• Working knowledge of regulatory requirements or current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.

• Working Knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.

• Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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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".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R332676