Job Description

As part of our Company's Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites.

The SDPC group is the division's 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 the science, engineering and knowledge required for today's innovative and accelerated commercialization of novel vaccines, biologics, pharmaceutical products and combination products. The SDPC group supports the growing pipeline of diverse products and evolving technologies.

We are seeking an Associate Principal Scientist who is an experienced drug product commercialization scientist/engineer, to advance and commercialize Innovative Large Molecules to clinical and commercial manufacturing sites. This person would be accountable for the planning and execution of activities associated with commercial design, characterization and technology transfer.

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

SDPC Drug Product Working Group Lead

• Responsible for the commercialization of a sterile drug product large molecule.

• Provides technical guidance and oversight of late-stage product and process characterization.

• Manages DP activities through filing and Process Performance Qualification (PPQ), including registration of stability study execution, process characterization plan and execution, technology transfer control strategy, process development, PPQ readiness, PAI (PreApproval Inspection) readiness, approval, launch and postlaunch support.

• Responsible for commercial site technology transfer and facility fit.

• Provides a regular summary of progress against development plan, key program and technical risks and risk level, mitigation strategies, and how success will be determined.

Product development and characterization

• Develops a process and product characterization plan.

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

• Develops a robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.

• Drives the design and execution of process characterization activities. Ensures fit-for-purpose scale-down models are developed and employed. Oversees lab studies, as required, to ensure 'right first time'.

• Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and challenging issues.

Technical leadership and oversight

• Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls and parameter classification.

• Establishes and validates platform engineering and scientific models for sterile product and process commercialization.

• Ensures commercialization programs meet requirements related to science, quality, reliability, schedule and cost. Monitors performance and recommends schedule changes, cost adjustments or resource additions.

• Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy (including filing storyboard) and filing readiness and supports preparations for agency meetings. Authors and review regulatory filings.

Continuous improvement

• Serves on cross functional teams and support strategic initiatives.

• Leads agile implementation of new/improved business processes in partnership with colleagues in Research Laboratories and the Manufacturing Division.

• Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.

Team Leadership

• Provides mentorship, technical oversight and strategic guidance to employees.

• Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.

• Manages a small group of individual contributors.

Education Minimum Requirements

• B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or

• Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or

• Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience

Preferred Experience and Skills

• Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.

• Experienced in sterile drug product fill finish manufacturing practices.

• Experienced in potent compound manufacturing processes.

• Knowledge or experience with single use system technologies.

• Working knowledge of 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.

• Experience with utilization of QbD principles to process development and life cycle management.

• Experience in Design of Experiment (DoE) and statistical data analysis.

• Experience in Data Analytics.

• Experience in authoring and reviewing CMC regulatory documentation.

• Analytical problem-solving skills and competency in technical writing.

• Project management and activities management skills (dashboards, activity trackers).

• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.

This position may require travel up to 25% Must be able to travel for this position.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

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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".

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:

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Hazardous Material(s):

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Requisition ID:R321123