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 experienced Principal Scientist to advance and commercialize the intravitreal (IVT) pipeline products. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process scale up, transfer and process validation activities at a start-up manufacturing site.

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

What you will do:

• Execute and provides oversight to intravitreal product and process design, development, characterization, technology transfer, and robust commercial validation.
• Serve on cross functional drug product (DP) working group and supports intravitreal DP activities through filing and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (PreApproval Inspection) readiness, approval, launch and postlaunch support.
• Ensure commercialization program meet requirements related to science, quality, reliability, schedule, and cost.
• Provide mentorship, technical oversight, and strategic guidance with respect to intravitreal process optimization. Uses advanced experience gained on scientific/technical issues to guide others to address complex technical challenges.
• Develop a process and product development plan. Influences decisions related to primary packaging.
• Innovate and drive best practices for commercial site tech transfer, facility fit and development of the DP control strategy.
• Define the classification of process parameters, performance parameters, operating ranges, in-process controls. Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy and author DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparation for agency meetings. Author and review regulatory submissions.
• Create the best and next practices in-process scale down, parameter finding, site characterization and transfer.
• Establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity, and inclusion.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with ten (10) years of relevant experience; OR
• Master of Science (M.S.) degree in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience; OR
• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with five (5) years of relevant experience

Preferred Experience and Skills:

• Background including comprehensive knowledge and hands on experience in the development of intravitreal products.
• Experienced in intravitreal/ophthalmic manufacturing practices and working practices for low particulate, low bioburden/endotoxin environments.
• Experienced in sterile drug product fill finish manufacturing practices including working with low volume fills and small batch scale.
• Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations.
• Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles.
• 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
• Experience in Data Analytics and Computer Modeling.
• Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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

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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:R316847