Merck
Associate Principal Scientist Engineer, Drug and Device Combination Products (Onsite)
USA - New Jersey - Rahway · Principal · Contract
Sponsorship not specified$142k-$224kDetected 1 day ago
Project ManagementHRISMechanical DesignManual TestingAR/VRGMPMedical DevicesResearchLeadershipCommunication
About the role
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- 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.
Responsibilities
- Technical (co)leadership of a Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV).
- Lead method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies.
- Lead, manage, and develop a team responsible for providing routine functional testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization.
- Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control (QC) facilities to ensure that functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System (QMS) compliance.
- Talent retention, training/upskilling, and recruiting of top talent as needed to deliver on pipeline and innovation projects.
- The Associate Principal Scientist / Engineer of Method Development, Testing & Transfer will be responsible for helping to lead the Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor in support of development activities, IND-enabling stability, commercial stability, and Design Verification.
- This role involves leading the method development technical strategy across multiple products and programs, and defining the transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies.
Requirements
- Demonstrated leadership experience in leading and managing teams, preferably in a regulated industry.
- Extensive knowledge of method development, validation, and transfer, with an understanding of regulatory requirements and industry best practices.
- Experience in collaborating with cross-functional teams including Quality, Regulatory, and QC facilities.
- Bachelor's or Master's degree in Mechanical Engineering, Chemical Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or equivalent field.
- Strong project management skills and the ability to prioritize and manage multiple projects effectively.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
- Required Education, Experience & Skills
- 7+ years of experience in method development, validation, and testing within the pharmaceutical, medical device, or combination product industry.
- #eligibleforERP
- Required Skills:
- Analytical Chemistry, Chemical Biology, Collaborative Development, Combination Products, Design Failure Mode and Effect Analysis (DFMEA), GMP Compliance, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Medicinal Chemistry, Project Management, Project Management Support, Quality Control Management, Quality Management Systems (QMS), Test Method Validation
Nice to have
- Advanced degree (PhD) preferred
- Preferred Skills:
Skills
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Compensation
- The salary range for this role is
Company info
- 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.
- 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.
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Equal opportunity
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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.
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- The salary range for this role is
Visa & Work Authorization
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This listing is sourced directly from Merck's careers page and normalized into a canonical job model.