Senior Scientist- External Large Molecule Analytical Sciences

Job Description

We are looking for an enthusiastic External Analytical Senior Scientist to join our team. In this role, you will oversee the analytical activities related to our large molecule products at our external partners, ensuring they meet the highest quality standards. You will work closely with external testing labs and various internal departments to ensure timely product release and maintain quality throughout the product lifecycle. This role will be a hybrid role.

Key Responsibilities:

• Provide analytical oversight and on site presence while collaborating with our external providers (biologics and vaccines).
• Build and sustain relationships with external partners and internal departments (operations, technology, procurement).
• Support departmental teams with facility start-up and ongoing operational activities.
• Collaborate with Global Analytical Working Groups and Subject Matter Experts (SMEs).
• Drive initiatives for continuous improvement in testing quality through best practices and proactive tools.
• Identify and resolve analytical issues and deviations from testing labs, ensuring accurate test results and project timelines.
• Prepare external testing sites for inspections by regulatory agencies (e.g., FDA, EMA, PMDA).
• Author and review technical documents for Process Performance Qualification (PPQ) and regulatory inquiries.

Required Skills and Experience:

• Analytical Product Lifecycle: Proficient in lifecycle activities (development, validation, transfer) for large molecule analytical platforms (e.g., ELISA, HPLC, CE).
• Biologics Analytical Technology Knowledge: Understanding of techniques such as bioassays (e.g., ELISA, cell-based methods), chromatography (HPLC, UPLC), and biochemistry methods including in process controls.
• Biopharmaceutical Industry Experience: Background in the biopharmaceutical sector, particularly in the commercialization of biologics or vaccines, technical operations, or quality control.
• Regulatory Knowledge: Understanding of regulatory requirements and guidelines (ICH, USP, Ph. Eur., JP).
• Organizational and communication Skills: Strong project management abilities to manage multiple tasks and projects effectively

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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. 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/5/2024

*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.

Requisition ID: R322196