Scientist, SoftMax Pro Template Validation (On-site)

MSD • North Wales, PA

1d • $87,300 - $137,400 • Onsite

About The Position

The Scientist in Large Molecule Analytical North American GMP Operations supports SoftMax Pro (SMP) template validations for relative potency, Host Cell Protein (HCP), and Protein A (ProA) methods. The role ensures SMP templates are built, validated, and managed to standardize methods and improve consistency across analytical workflows supporting clinical and commercial testing. The position requires hands-on SoftMax Pro experience and the ability to work in a fast-paced, multidisciplinary environment.

Requirements

• Bachelor’s degree in biology, biochemistry, or a related science, with 3 years of relevant experience in SoftMax Pro, analytical development, validation, and/or quality control; alternatively, a master’s degree in biology, biochemistry, or a related science is listed as the education minimum.
• Proven experience using and building SoftMax Pro templates.
• Strong understanding of data processing, curve fitting, calculations, and reporting.
• Experience with ELISA and cell-based relative potency methods and/or residual ELISA methods.
• Understanding of and adherence to ALCOA documentation principles.
• Strong organizational skills and proven ability to manage timelines and deliverables.
• Ability to proactively identify and resolve technical issues and communicate risks.
• Ability to work independently with minimal supervision.
• Ability to engage, communicate, and collaborate effectively with others.
• Experience with change control processes.
• Self-motivation, a positive attitude, strong interpersonal skills, and aptitude for learning.

Nice To Haves

• Experience working in a regulated environment, such as GMP or GLP.
• Experience with method development and analytical method validation.
• Experience with life cycle management or regulatory submissions.
• Knowledge of USP, EP, ICH, and FDA regulations.

Responsibilities

• Build SoftMax Pro templates for relative potency, HCP, and ProA assays to support accurate data capture, processing, and results reporting.
• Manage template validation timelines cross-functionally with Large Molecule Assay Validation, Quality Assurance, and commercial laboratories.
• Author and approve validation deliverables, including requirement and configuration specifications, test cases, and quality assurance summary reports.
• Perform test case dry runs to confirm template functionality and formula logic accuracy.
• Troubleshoot template issues and implement improvements.
• Support training and transfer of validated templates to end users.
• Own change controls for new template implementation and revisions to validated templates.
• Perform work in accordance with ALCOA principles, applicable SOPs, quality standards, and regulatory expectations.
• Execute potency and residual ELISA methods.
• Perform additional duties as assigned to support department needs.
• Occasionally work irregular hours, including evenings and weekends, as needed.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level