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 to advance and commercialize the intravitreal (IVT) pipeline products. As a member of the drug product team, the Associate Principal Scientist will be accountable for planning and execution of activities associated with commercial design, characterization, and transfer of process to commercial manufacturing sites.

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

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

• Technical guidance and oversight of late-stage product and process development.
• Manages 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, PAI (PreApproval Inspection) readiness, approval, launch and postlaunch support.
• Develops a robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.
• Develops a process and product development plan. Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
• 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/or difficult issues.
• Responsible for commercial site technology transfer and facility fit. Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls, and parameter classification.
• Influences primary packaging decisions. Drives and influences process demonstration and qualification (PPQ) strategy.
• 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.
• 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.
• 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.
• 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 products presentations.
• Provides mentorship, technical oversight, and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
• Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity, and inclusion.
• Potentially manages a small group of individual contributors (professional and contract employees).

Minimum Education Requirements and Experience:

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience; OR
• Master of Science (M.S.) degree in chemical engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of relevant experience; OR
• Ph.D. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with three (3) 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 intravitreal/ophthalmic manufacturing practices and working in 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.
• 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 authoring and reviewing CMC regulatory documentation.
• Analytical problem-solving skills and competency in technical writing.
• Project management and activities management skills (dashboards, activity trackers).
• Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
• Experience in Design of Experiment (DoE) and statistical data analysis.
• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
• Experience in Data Analytics

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R317190