Associate Principal Scientist, Glass & Critical Components, Device Development and Technology

Job Description

We are seeking a highly experienced and skilled Senior Glass and Critical Component Technical Expert to join our team as a key technical support resource for our pharmaceutical and combination product engineering projects. The ideal candidate will have extensive knowledge and expertise in the design, development, and manufacturing of glass components such as syringes and vials for pharmaceutical and combination product applications.

Position title

• Associate Principal Scientist — Glass & Critical Components

Location

• West Point, PA or Rahway, NJ (Hybrid). Travel up to 15–25% as needed.

Reporting

• Reports to: Distinguished Scientist, Glass & Critical Components

Role summary

• The Associate Principal Scientist — Glass & Critical Components is a senior technical contributor and subject-matter specialist responsible for engineering, qualification, supplier technical oversight, and lifecycle support of glass primary containers (syringes, vials, cartridges) and other critical components used in pharmaceutical combination products and drug-delivery devices. The role applies materials science, failure analysis, process control, and regulatory knowledge to ensure component performance, manufacturability, supply robustness, and patient safety across development, transfer, and commercialization phases. The Associate Principal Scientist will lead technical investigations, drive component qualification strategies, and collaborate cross-functionally with device engineering, formulation, quality, regulatory, and suppliers.

Key responsibilities

• Technical expertise and problem solving

  • Serve as a primary technical resource for glass and related critical components, applying deep materials science knowledge to characterize component performance and failure modes (e.g., fractography, strength testing, contamination).

  • Lead root-cause investigations into glass breakage, handling, and other component-related events; develop evidence-based corrective and preventive actions.

• Component design, qualification & development

  • Define material and component specifications, acceptance criteria, and test strategies aligned to product use and regulatory expectations.

  • Lead and execute qualification packages for new components, including feasibility studies, performance testing, compatibility considerations, and documentation to demonstrate fitness for use.

• Process control and manufacturing readiness

  • Develop process control strategies and acceptance criteria for suppliers and manufacturing, using data-driven methods (DOE, SPC, capability studies) to characterize risk and variation.

  • Support technical transfer activities to internal and contract manufacturing sites to ensure consistent component supply and manufacturing readiness.

• Supplier technical management

  • Collaborate with suppliers to assess technical capability, resolve quality or performance issues, review supplier change controls, and implement supplier improvement plans.

  • Participate in supplier evaluations, technical audits, and capability development activities in partnership with procurement and quality functions.

• Cross-functional collaboration & regulatory interface

  • Work closely with Quality and Regulatory Affairs to ensure component specifications, testing strategies, and documentation meet applicable standards and guidance (e.g., USP, ISO, FDA).

  • Provide technical inputs for submissions, inspection readiness, and responses related to component qualification and lifecycle control.

• Lifecycle oversight and continuous improvement

  • Monitor post-launch component performance and supplier metrics; lead investigations and continuous improvement projects to reduce component-related events and improve yield.

  • Evaluate and recommend new materials, surface treatments, or manufacturing technologies that can improve component performance, manufacturability, sustainability, or cost-effectiveness.

• Mentorship & team contribution

  • Mentor junior engineers and scientists; share technical expertise to elevate team capability and contribute to knowledge sharing across the organization.

Qualifications and experience

Education Requirements

• BS in Materials Science, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field required.

• MS or PhD preferred.

Required Experience and Skills

• Typically 6–12 years of relevant industry experience in glass engineering, primary container/component engineering, or related roles supporting pharmaceutical or combination products. (Candidates with deeper hands-on experience may be advanced within this range.)

• Demonstrated experience with glass syringes, vials, cartridges, or similar primary containers — including familiarity with manufacturing processes, common defects, handling-related damage mechanisms, and analytical methods (fractography, strength testing).

• Experience leading component qualification, technical transfer, supplier technical management, and failure investigations.

• Working knowledge of regulatory expectations and industry standards relevant to primary containers (USP, ISO, FDA guidance).

• Skills and competencies

  • Strong problem-solving and root-cause analysis skills; able to lead investigations and implement robust corrective actions.

  • Proficiency with statistical and experimental methods (DOE, SPC, capability studies) to inform process control and qualification decisions.

  • Excellent written and verbal communication; able to present technical findings clearly to cross-functional and external stakeholders.

  • Ability to influence suppliers and internal partners and to work effectively in matrixed teams.

  • Experience in medical devices or primary sterile container component development, regulations including ISO 11040, USP <661>.

Preferred Experience and Skills

• Prior experience with combination product assembly or drug-delivery platforms (autoinjectors, prefilled syringes).

• Familiarity with extractables & leachables considerations for glass and primary container materials.

• Knowledge of surface treatments/coatings (siliconization, barrier coatings) and advanced glass technologies.

• Experience conducting supplier audits and managing global supplier technical relationships.

• Experience in purchasing controls and component qualification

• Advanced degree in Materials Science or related field.

Performance expectations / success measures

• Cross Functional leadership in driving timely delivery of high-quality component qualification and technical transfer packages, and/or resolution of supply issues.

• Reduction in component-related quality events and supplier escalations through effective investigations and risk mitigation.

• Improvements in supplier process capability and yield where applicable.

• Positive stakeholder feedback for technical leadership and cross-functional collaboration.

• Contribution to innovations or process improvements that enhance component performance, reliability, or supply stability.

Required Skills:

Biomedical Engineering, Biomedical Engineering, Combination Products, Component Development, Component Qualification, Cross-Functional Collaboration, Cultural Diversity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Diversity Awareness, Functional Leadership, Inspection Readiness, Interdisciplinary Collaboration, Materials Engineering, Materials Science, Mechanical Testing, Medical Device Quality Systems, Medical Devices, Medical Devices Engineering, Medical Device Technologies, Negotiation, Quality Management Systems (QMS), Self Motivation, Technical Leadership {+ 1 more}

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 salary range for this role is

$142,400.00 - $224,100.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/19/2026

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