Scientist, Biologics Analytical R&D

Job Description

Scientist Biologics Analytical

North American GMP Operations, North Wales, PA

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a diverse workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.

We are actively seeking an enthusiastic individual to join our North Wales, PA team as a Scientist in Biologics Analytical Research & Development (AR&D) GMP Operations, to support separations methods ( e.g. HPLC, UPLC, CE, iCIEF ). In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage analytical transfers, analytical life cycle management, and release and stability testing. The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts .

The incumbent will collaborate closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.

Responsibilities

• Validate and implement analytical methods to support release and stability testing of clinical materials.

• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).

• Act as subject matter expert (SME) across various franchises and analytical platforms.

• Support biologics registrations, product launches, and troubleshooting activities.

• Support compliance audits, inspection activities, and investigation/CAPAs .

• Author and review technical documents.

• Complete assigned work within established project timelines.

• Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.

• Manage laboratory equipment, laboratory supplies and critical reagent inventories.

• Additional responsibilities as assigned to support the evolving needs of the department.

Qualifications

• Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, or M.S. degree .

Experience and Skills

Required

• At least 1 year experience working in a GMP environment

• Experience with separation techniques such as HPLC, UPLC, CE, iCIEF , or other advanced technology.

• Proficiency with data analytics.

• Understanding and adherence to ALCOA principles for documentation .

• Strong organizational skills and ability to manage work to meet project timelines.

• Capability to work independently with minimal supervision.

• Ability to identify and resolve common technical issues.

• Effectively engage, communicate, and collaborate with others.

• Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.

• Willingness to occasionally work irregular hours, including evenings and weekends, as needed.

Preferred

• Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.

• Knowledge of USP, EP, ICH, and FDA regulations.

• Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.

• Experience with electronic notebooks.

• Knowledge of deviation management and change control processes.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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 anothers 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

$85,600.00 - $134,800.00

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 employees 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 .

You can apply for this role through (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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Analytical Development, Analytical Method Development, Applied Engineering, Biochemistry, Biopharmaceutical Industry, Cell-Based Assays, Change Control Processes, Collaborative Communications, Data Analytics, Fast-Paced Environments, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Immunoassays, Immunochemistry, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Maintenance, Laboratory Techniques, Mammalian Cell Culture, Management Process, Multidisciplinary Collaboration, Real Time Polymerase Chain Reaction (qPCR) {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/14/2025

*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.