Scientist - Biologics Inline Support

Biologics Inline Support

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 company's 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

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 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.