Manufacturing Associate I - Protein Purification

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

Benefits offered by this job

Competitive salary

Medical/dental/vision insurance

Retirement plan with employer matching

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Biologics seeks a Manufacturing Associate I to participate in biopharmaceutical drug product manufacturing in the Protein Purification area, operating in a GMP environment to ensure materials meet specifications and regulatory requirements.

This role supports multiple clinical programs, with opportunities to contribute to batch records, SOPs, and continuous improvements, while maintaining a safe, compliant manufacturing space.

Qualifications

• 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.

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, 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.

Skills

Protein purification

Technical writing

Teamwork

Multi-tasking

Troubleshooting

Equipment operation

Lifting 30 lbs

Education

High School diploma or equivalent

Associate degree

Bachelor's degree

Job description

About Bora

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from FirstinHuman through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purposebuilt for commercialization. Our inspectionproven, bicoastal 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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

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.