Job Description

As part of our 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 a Senior Scientist to be the lead drug product scientist responsible for establishing and executing commercial process development studies for targeted biologics pipeline and inline programs. The Senior Scientist will develop and transfer robust and scalable manufacturing processes while minimizing time to launch and implement process improvements to reduce cost structure and enhance process robustness.

Responsibilities

• Design and execute studies to develop and characterize sterile drug product processes, including the establishment of the commercial integrated control strategy.
• Develop and transfer robust processes to the Drug Product (DP) commercial manufacturing site.
• Build strategy and technical framework for process validation at commercial sites.
• Manage DP activities for inline and pipeline programs, including completion of regulatory filings and product life-cycle management.
• Ensure appropriate experimental design principles, including DOE, are used where applicable.
• Ensure fit-for-purpose scale-down models are developed and employed.
• Author technical protocols for studies, ensuring appropriate design of experiments and sample size selection.
• Ensure acceptance criteria for study outcomes are pre-defined (e.g., performance parameter range, analytical result range, etc.).
• Responsible for sample submission and tracking, employing statistical tools and methods to analyze results.
• Author technical reports that can be used as source documentation for regulatory filing.
• Ensure technical information is clearly understood and integrated into decision-making.
• Author or perform second-person review (SPR) for high-quality CMC sections for regulatory submissions.
• Establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Apply technical and functional knowledge to design experiments that contribute to the overall direction of the department/discipline.
• Serve on cross-functional teams to support strategic initiatives.
• Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations.
• Establish and foster a culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, and inclusion.

Qualifications

Required

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of hands-on experience in laboratory DP Process development, scale-up, and technology transfer of sterile drug product manufacturing process experience OR MS with four years, OR Ph.D. with no industry experience.
• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
• Experience in the process development and manufacturing of large biological molecules, with an understanding of protein attributes.

Preferred

• Experience in process optimization, scale-up, and technology transfer of sterile biologics products to pilot/commercial scale.
• 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 authoring and reviewing CMC regulatory documentation.
• Project management and activities management skills (dashboards, activity trackers).
• Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
• Competency in problem-solving skills and technical writing.

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

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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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