Biomaterials Program Lead

HireLifeScience; De Soto (KS); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

HireLifeScience seeks a Biomaterials Program Lead to drive lifecycle management of critical biomaterials used in animal health biologics, including knowledge management, inventory, and USDA-ready reporting.

You will lead equivalence studies, remediation efforts, and cross-functional coordination with Manufacturing, QC, QA, Regulatory Affairs, R&D, and suppliers to ensure regulatory readiness and high-quality science.

Qualifications

• Bachelor's degree in a biological science and extensive regulatory experience.
• Minimum of 7 years in USDA-regulated animal health biologics.
• Minimum of 5 years qualifying biomaterials documentation for regulatory review.
• Subject matter expertise in at least one biological method platform.
• Strong technical writing for regulator-ready reports and justifications.

Responsibilities

• Lead biomaterials knowledge management including production history and qualification status.
• Manage biomaterials inventory strategy, lead times, expiry risks and reorders.
• Coordinate replacement biomaterials planning via outsourcing or internal sourcing.
• Design and document equivalence qualification studies for USDA approval.
• Lead or support method remediation when biomaterial changes impact tests.
• Coordinate transfer of biomaterials and remediated methods to QC labs.
• Prepare technical reports and regulatory support documents for USDA review.
• Partner with Manufacturing, QC, QA, Regulatory Affairs, R&D and external suppliers.

Skills

Adaptability

Analytical Method Transfer

Animal Health Care

BioAssay

Biological Assessments

Biological Testing

Biologics

Biomaterials

Bioproduction

Cross-Functional Teamwork

Leadership

Method Development

Method Validation

Microbiological Test

Quality Control (QC)

Technical Problem-Solving

USDA Regulations

Education

Bachelor's degree in Biological Science

Job description

Job Description

The Biomaterials Program Lead will provide technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing. This role is responsible for biomaterials knowledge management, inventory and reorder strategy, replacement sourcing, equivalence qualification, method remediation, QC transfer support, and preparation of USDA-ready technical reports.

Key Responsibilities

• Lead biomaterials knowledge management, including documentation of production history, characterization, inventory status, qualification status, and method dependencies.
• Manage biomaterials inventory strategy, including reorder levels, usage trends, lead times, expiry risks, and replacement triggers.
• Lead replacement biomaterials planning through outsourcing, commercial vendors, and internal sourcing options.
• Design, coordinate, and document equivalence qualification studies for replacement biomaterials to support USDA approval.
• Lead or support method remediation when biomaterial changes or performance issues impact biological test methods.
• Coordinate transfer of biomaterials and remediated methods to QC laboratories, ensuring documentation and readiness expectations are met.
• Prepare technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA review.
• Partner cross-functionally with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers.

Minimum Qualifications

• Bachelor's degree in a biological science, such as Biology, Microbiology, Genetics, Virology, or a closely related discipline.
• Minimum of 7 years of experience in USDA-regulated animal health biologics.
• Minimum of 5 years of experience qualifying and preparing biomaterials-related technical documentation for regulatory review.
• Subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems.
• Strong technical writing skills with the ability to prepare clear, science-based, regulator-ready reports and justifications.

Preferred Qualifications

• Experience working with USDA.
• Experience with regulated quality systems.
• Experience with method validation and transfer.
• Experience collaborating across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external organizations.

Required Skills:

Adaptability, Analytical Method Transfer, Animal Health Care, BioAssay, Biological Assessments, Biological Testing, Biologics, Biomaterials, Bioproduction, Cross-Functional Teamwork, Leadership, Method Development, Method Validation, Microbiological Test, Quality Control (QC), Technical Problem-Solving, Test Method Validation, USDA Regulations

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.

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

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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 $129,000.00 - $203,100.00

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.

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Job Posting End Date:

10/21/2026

Requisition ID:

R419128