Scientist - Biologics Inline Support

Job Description

The Global Quality Large Molecule Analytical Sciences (GQLMAS) team is accountable for the inline analytical support and product lifecycle management of Large Molecules (Vaccines and Biologics) and Cross-Modality Compounds (i.e. Antibody Drug Conjugates). This team is highly motivated, fast-paced and focused on a robust analytical testing network that enables our companys strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product.

This Biologics Inline Support position will involve method optimization, testing, troubleshooting, analytical tech transfer, and analytical procedure lifecycle (APLC) management with a focus on inline large molecule (vaccine, biologics) protein content methods (e.g. UV by A280, content uniformity, SoloVPE) and separations methods (e.g. CE, icIEF, HPLC, UPLC). The successful candidate will interface with our QC partners across our Company network and external partners to provide SME support where needed.

Education

• Bachelor of Science (BS) degree in biology, chemistry, biochemistry, or related science with three (3) years working in current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in chromatographic analytical methods; OR

• Master of Science (MS) degree in biology, chemistry, biochemistry, or related science with one (1) year working in current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in chromatographic analytical methods.

Key Responsibilities

• Act as an analytical subject matter expert (SME) and global Method Owner to troubleshoot and optimize analytical methods, with a strong focus on protein content methods (e.g. UV by A280, content uniformity, and SoloVPE.

• Support separations assays (e.g. liquid chromatography (HPLC, UPLC), capillary electrophoresis (CE), imaged capillary isoelectric focusing (icIEF)).

• Maintain broad experience across diverse separations and biochemical assays with the ability to design experiments, analyze data, and implement effective solutions.

• Collaborate with cross functional teams to ensure successful QC-to-QC tech transfer of analytical methods.

• Large Molecule Analytical Procedure Lifecycle (APLC) activities across various franchises and analytical platforms, including leading Gap Assessments and Method Standardizations

• Support various biologics and/or vaccine post-marketed CMC regulatory submissions.

• Lead/support complex technical investigations and drive resolution of analytical technical issues.

• Support strategic initiatives within departmental and cross-functional teams representing GQLMAS.

Experience | Knowledge | Skills

Required

• In-depth expertise with protein content methods (e.g. UV by A280, SoloVPE, content uniformity)

• Familiarity and experience with separations methods (e.g. HPLC/UPLC, CE, and icIEF)

• Experience with WinUV and Viper software as well as Chromatography Data Systems (e.g. Empower, Astra, Chromeleon)

• Late-stage method development, validation, transfer, and troubleshooting

• Minimum one year working in current Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (vaccines, biologics)

Preferred

• Authoring and review of technical documents

• 2 years relevant analytical execution, development, validation, and/or quality control (QC) for biologic and/or vaccine release, stability, and in-process methods.

• Familiarity with large molecule release/stability methods for Antibody Drug Conjugates (ADC)

• Ability to work objectively, independently, and within a cross-functional team and learn new techniques

• Good technical, communication (oral and written), interpersonal, and teamwork skills

• Self-motivated with a positive attitude and proven performance record

• Strong organizational and project management skills

#eligableforerp

VETJOBS

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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 anothers thinking and approach problems collectively.

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Analytical Development, Analytical Method Development, Antibody Therapeutics, Assay, Biochemical Analysis, Biochemical Assays, Biochemistry, Capillary Electrophoresis (CE), Cell-Based Assays, Chemical Biology, Chromeleon, Communication, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Project Management, Real Time Polymerase Chain Reaction (qPCR), Science, Self Motivation, Social Collaboration {+ 3 more}

Preferred Skills:

Job Posting End Date:

09/3/2025

*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.