Merck & Co, Inc

Scientist, SoftMax Pro Template Validation (On-site)

Merck & Co, Inc • $87K — $137K *
North Wales, PA 19454In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in biology, biochemistry, or a related science; Master's degree preferred.
  • 3 years of experience in SoftMax Pro, analytical development, or quality control.
  • Proven experience building SoftMax Pro templates and conducting ELISA methods.
  • Strong understanding of data processing, curve fitting, and calculations.
  • Familiarity with ALCOA principles and compliance standards.

Responsibilities

  • Build SoftMax Pro templates for assays ensuring accurate data capture.
  • Manage validation timelines across multiple departments.
  • Author and approve template validation deliverables, such as specifications and reports.
  • Conduct test case dry runs to verify template functionality and logic accuracy.
  • Troubleshoot and enhance template functionality as required.
  • Facilitate training sessions for users of the validated templates.
  • Oversee change controls for template implementation and revisions.

Benefits

  • Join a dynamic, multidisciplinary team in a fast-paced environment.
  • Opportunity for professional growth and skills development.
  • Work at the forefront of analytical methods in the pharmaceutical industry.
  • Engage in meaningful work with a direct impact on clinical and commercial testing activities.
Full Job Description
Job Description

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 SoftMax 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 SoftMax Pro software and be able to work in a fast-paced, multidisciplinary environment.

Key Responsibilities
  • Build SoftMax 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 SoftMax 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 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 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.


ARD

EligbleforERP

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, SoftMax Pro, Technical Writing

Preferred Skills:

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
09/8/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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