Sr. Scientist, External Analytical Sciences

MSD; Segrate; Ibrido; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company in the biopharmaceutical industry is seeking an experienced professional for a pivotal role in analytical oversight of large molecules and vaccines. You will collaborate with external testing providers and internal stakeholders to ensure high-quality analytical testing and compliance with regulatory standards. The position demands strong project management skills and expertise in GXP laboratory environments. Ideal candidates will have a background in life sciences and experience in analytical method development, contributing to lifecycle management and product success.

Competenze

• At least 4 years experience in a GXP laboratory environment.
• Understanding of biologics analytical technology (e.g. ELISA, HPLC).
• Experience with regulatory requirements according to ICH and USP.

Mansioni

• Direct and manage analytical activities within commercial external manufacturing.
• Collaborate with cross-functional commercial manufacturing teams.
• Drive continuous improvement initiatives to enhance quality and robustness of testing.

Conoscenze

Analytical Method Development

Analytical Testing

Project Management

Change Control Processes

Formazione

Bachelor’s Degree in Biology, Chemistry or related science

Master’s Degree in Biology, Chemistry or related science

PhD in Biology, Chemistry or related science

Strumenti

Laboratory Information Management System (LIMS)

Software automation/digital systems

Descrizione del lavoro

Job Description

The Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for 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 company’s strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product. This External Analytical position will direct and manage the analytical activities within our commercial external manufacturing and testing network. This role involves developing and implementing site-related analytical strategies, and site implementation of continuous improvement in analytical methods and techniques and driving successful analytical execution by the contract testing lab(s) to support on time batch release.

Additionally, this position will work directly with technical operations, quality, regulatory, microbiology, and analytical program leaders on a regular basis to review/approve critical documents relating to analytics and participate as a site representative for method life-cycle related tasks

Responsibilities include but are not limited to:

• Analytical technical oversight working directly with the external provider(s) and internal cross-functional stakeholders to support analytical testing of large molecule (biologics and/or vaccine) products.
• Position includes significant on-site presence at external testing provider(s) to support direct engagement and technical oversight of critical analytical testing activities.
• Build and maintain strong relationship with External Entities, as well as internal operations, technology, analytical and procurement organizations. Closely collaborates with appropriate business and functional areas to conduct Tier meetings, and Joint Steering Committee meetings (as applicable) to achieve our objectives.
• Collaborate with departmental and cross-functional commercial manufacturing teams to support facility start-up and sustainability activities.
• Interface with Global Analytical Working Groups and Global Method Owners/SMEs
• Drive continuous improvement initiatives to enhance the quality and robustness of external /testing through implementation of proactive tools, assay data trending, corrective actions and best practices.
• Identify and resolve analytical issues, deviations, and out-of-specification results from external testing labs through technical support of investigating and troubleshooting analytical problems to ensure the accuracy and reliability of test results.
• Lead/support complex investigations and drive resolution of analytical technical issues
• Build and manage project plans, timelines, and schedules to effectively meet project timelines and deliverables.
• Ensure our external testing sites are prepared for inspections from multiple agencies (i.e. FDA, EMA, PMDA) from an analytical technical perspective
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ), licensure and regulatory technical questions

Skills

Minimum Education Required and Experience:

• Bachelor’s Degree (BA/BS) with a concentration in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
• Master’s Degree (MA/MS) with a concentration in biology, chemistry, biochemistry, or related science with four (4) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
• PhD with a concentration in biology, chemistry, biochemistry, or related science with two (2) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation.

Required Skills and Experience:

• At least 4 years working experience in a GXP laboratory environment in the area of large molecules (vaccines, biologics) analytics or Cross-Modality Compounds.
• Experience in analytical product life cycle activities (development, validation, and /or transfer) across various large molecule analytical platforms (i.e. ELISA, HPLC, CE).
• Understanding biologics analytical technology such as bioassay (i.e. ELISA, cell-based methods), chromatography (i.e. HPLC, UPLC), and general biochemistry methods.
• Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, and/or Quality control.
• Knowledge with In-Process Controls, drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics
• Experience with regulatory requirements and guidelines according to ICH, USP, Ph. Eur., and JP.
• Strong organizational and project management skills to handle multiple project associated tasks simultaneously.
• Strong oral and written communication skills to effectively communicate technical information and risks to both technical and non-technical stakeholders.

Preferred Skills and Experience :

• Knowledge of deviation management and change control processes.
• Ability to analyze, interpret, and troubleshoot analytical data.
• Experience in method transfer, method validation, new product introduction, and/or analytical product life cycle activities across various large molecule franchises and analytical platforms.
• Worked and interfaced with external partners (i.e. CMOs and CTLs).
• Self-motivated with a positive, proactive, and service-oriented mindset.
• Capability to adapt and be flexible in a fast paced cross-functional team working environment.
• Experience with laboratory data management systems (i.e., LIMS).
• Experience with software automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Analytical Testing, Assay Development, Bioanalytical Analysis, Biochemical Analysis, Biochemical Assays, Biochemistry, Biopharmaceutical Industry, Biopharmaceuticals, Cell-Based Assays, Change Control Processes, Chemical Biology, Chromatographic Techniques, Cognitive Flexibility, GMP Environments, Innovative Thinking, Investigation Procedures, Laboratory Information Management System (LIMS), Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Project Management, Project Planning, Strategic Thinking {+ 1 more}

Preferred Skills:

Job Posting End Date:

06/25/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.