Associate Principal Scientist, Biologics Analytical Research & Development

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co. is seeking an Associate Principal Scientist in Rahway, NJ to lead development and qualification of analytical methods for monoclonal proteins and other complex biologics. You will design experiments, interpret data, and drive cross-functional collaboration to support drug substance and product development.

The role emphasizes leadership of small teams, rigorous documentation, and communication of results for regulatory filings and project milestones in a fast-paced environment.

Qualifications

• Strong background in separations science.
• Experience with UPLC/HPLC analysis of biologics (SEC, RP, IEX).
• Experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques.
• Background in Analytical Methodologies and statistics for setting specifications.

Responsibilities

• Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins or other complex therapeutic proteins.
• Design, execute and/or direct design of experiments and data interpretation.
• Lead transfer of assays and ensure documentation meets program deadlines.
• Author and review internal technical reports and regulatory filing sections (IND, BLA).
• Mentor small groups and collaborate cross-functionally on projects.

Skills

Adaptability

Analytical Method Development

Assay Development

Biological Assay Development

Cell-Based Assays

Chromatographic Techniques

Cross-Functional Teamwork

External Collaboration

HRMS

LC-MS

Mass Spectrometry Analysis

Optimism

PAT

Protein Analysis

Teamwork

Education

Bachelor's degree in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field

Job description

Job Description

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.- The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.- The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Responsibilities include development of new assay platforms, benchmarking current approaches/techniques to industry standards, and providing technical leadership of design of experiments and data interpretation.- Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish.- Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates.- Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred.-

Qualifications

Education

• B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 12 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.

Required Experience and Skills:

• Strong background and experience in separations science
• Extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX)
• Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques
• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development
• A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.
• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.
• Experience with matrix management and peer to peer coaching
• Accurately and efficiently documentation of experiments
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills:

• Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.
• Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP .

• Experience in representing analytical functional area on project teams.-
• Experience with complex glycan analysis and link to mechanisms of actions.
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).

AR&D

Required Skills:

Adaptability, Analytical Method Development, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimism, Process Analytical Technology (PAT), Protein Analysis, Teamwork

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position