Manufacturing Associate I – Protein Purification

Bora Biologics USA LLC; Rockville (MD); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive health coverage

Retirement savings plans

Paid time off

Professional development

Employee wellness programs

Employee Assistance Program

Job summary

Bora Biologics USA LLC is seeking a Manufacturing Associate I to support the Protein Purification area and manufacturing of biopharmaceutical material for multiple clinical programs. You will work in the GMP manufacturing suite to ensure materials meet specifications and regulatory requirements.

The role requires a high school diploma or higher with related biopharmaceutical experience or an associate/bachelor’s degree in a related field.

Qualifications

• Education & experience as listed in the Minimum Education section.
• Knowledge of protein purification techniques and GMP documentation.
• Ability to write and revise technical documents and maintain accurate records.

Responsibilities

• Participates in hands-on production in the manufacturing of commercial and clinical material in a GMP environment.
• Performs purification operations including filtration, chromatography, titrations, column packing, TFF and bulk fill.
• Maintains manufacturing area in a clean, neat, and orderly condition at all times.
• Adheres to SOPs and batch records under GMP regulations to document activities clearly and accurately.
• Follows safety policies when working with hazardous materials.

Skills

Protein purification techniques

Technical document writing

Team collaboration

Multi-tasking

Problem-solving

Equipment operation

Safety in GMP environment

Adaptability

Attention to detail

Education

High School Diploma or equivalent

Associate degree in related field (optional with 1 year experience)

Bachelor’s degree in related discipline (no experience)

Tools

SAP

Job description

About Bora

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary

The Manufacturing Associate I participates in the manufacturing of biopharmaceutical drug product to support Bora Biologics’ multiple clinical programs in the Protein Purification area. This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) to ensure that materials manufactured meet required specifications and regulatory requirements.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Responsibilities and Job Duties

• Participates in hands‑on production in the manufacturing of commercial and clinical material in a GMP environment.
• Performs purification operations including filtration, chromatography, titrations, column packing, Tangential Flow Filtration (TFF) and bulk fill.
• Consumes and scrap solutions, raw materials, consumables and components in SAP.
• Contributes to the creation and revision of Batch Records, Standard Operating Procedures, Material Specifications, and other GMP documents.
• Adheres to all SOPs and batch records under GMP regulations to document all manufacturing activities clearly and accurately.
• Maintains adequate supplies to perform routine equipment maintenance.
• Maintains manufacturing area in a clean, neat, and orderly condition at all times.
• Participates in a variety of projects designed to improve the quality and efficiency of the manufacturing team.
• Follows all related safety policies and procedures when working with hazardous materials.

Minimum Education, Experience & Skills

• Education & Experience High School Diploma or equivalent with exposure to science and math coursework and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.
• OR Associate degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.
• OR Bachelor’s degree in a related discipline with no experience.

Knowledge, Skills and Abilities

• Knowledge of protein purification techniques
• Ability to write and revise technical documents
• Ability to work occasional weekends or overtime as needed
• Ability to follow detailed instructions and to maintain accurate records
• Ability to work effectively in a team environment
• Ability to successfully perform multiple tasks, when required
• Skills in problem‑solving and troubleshooting
• Ability to safely operate production equipment in accordance with established procedures
• Ability to lift up to 30 lbs.

Salary Range

$60,000-$75,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future‑focused company, we know better than most that our own success is shaped by our partners victories.