Scientist, SoftMax Pro Template Validation; On-site

Scientist In Large Molecule Analytical North American GMP Operations

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity.

With a varied workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.

We are seeking an enthusiastic, detail-oriented individual to join our North Wales, PA team as a Scientist in Large Molecule Analytical North American GMP Operations to support Soft Max Pro template validations for relative potency, HCP (Host Cell Protein), and ProA (Protein

A) methods. This role is accountable for ensuring SMP templates are built, validated, and managed to ensure method standardization and to improve consistency across analytical workflows to support clinical and commercial testing activities. The ideal candidate must have strong hands-on experience with Soft Max Pro software and be able to work in a fast-paced, multidisciplinary environment.

Key Responsibilities

• Build Soft Max Pro templates for relative potency, HCP, and ProA assays, ensuring templates support accurate data capture, processing, and results reporting.
• Cross-functionally manage SMP template validation timelines with Large Molecule Assay Validation, Quality Assurance, and commercial laboratories.
• Author and approve template validation deliverables including requirement and configuration specifications, test cases, and quality assurance summary reports that document template design, functionality, testing outcomes, and validation results.
• Perform test case dry runs to confirm template functionality and accuracy of all formula logic.
• Troubleshoot template issues and implement improvements as needed.
• Support training and transfer of validated templates to end users.
• Own change controls for new template implementation and validated template revisions.
• Ensure work is performed following ALCOA principles and in compliance with applicable SOPs, quality standards, and regulatory expectations.
• Execute potency and residual ELISA methods.
• Perform additional duties as assigned to support the evolving needs of the department.
• Willingness to occasionally work irregular hours, including evenings and weekends, as needed.

Position

Qualifications:

Education Minimum Requirement:

• Bachelor's degree in biology, biochemistry or related science with 3 years of relevant experience in Soft Max Pro, analytical development, validation, and/or quality control (QC).
• Master's degree in biology, biochemistry or related science.

Required

Experience and Skills:

• Proven experience using and building Soft Max 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 and adherence to ALCOA principles for documentation.
• Strong organizational skills with proven ability to manage timelines and deliverables.
• Ability to proactively identify and resolve technical issues and communicate risks
• Capability to work independently with minimal supervision.
• Effectively engage, communicate, and collaborate with others.
• Experience with change control processes.
• Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.

Preferred

Experience and Skills:

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

Required Skills:

Analytical Thinking, Cell-Based Assays, Change Controls, Document Management, Ethical Standards, Good Manufacturing Practices (GMP), Immunoassays, Laboratory Techniques, Mammalian Cell Culture, Regulatory Compliance, Soft Max Pro, Technical Writing

Preferred

Skills: