Job Description
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 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
Current Employees apply HERE
Current Contingent Workers apply HERE
US And Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
Requirements
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is
$87,300.00 - $137,400.00
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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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:
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.
Requisition ID:R413167
