Manufacturing Associate I – Protein Purification

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

Job summary

Bora Biologics in Rockville, MD is hiring a Manufacturing Associate I to support multiple clinical programs in the Protein Purification area. You will work in the GMP manufacturing suite to ensure materials meet specifications and regulatory requirements.

Responsibilities include purification operations (filtration, chromatography, TFF, and bulk fill), maintaining batch records and SOPs, and assisting in process improvements and safety compliance.

Qualifications

• Two years of related biopharmaceutical manufacturing experience in FDA-regulated environment.
• Knowledge of protein purification techniques.
• Ability to write and revise technical documents.
• Ability to work weekends or overtime as needed.

Responsibilities

• Participates in hands-on production in GMP manufacturing of clinical and commercial material.
• Performs purification operations including filtration, chromatography, tangential flow filtration (TFF) and bulk fill.
• Consumes and scraps solutions, raw materials, consumables and components in SAP.
• Maintains batch records, SOPs, and material specifications.
• Keeps manufacturing area clean and compliant with GMP and safety policies.
• Participates in projects to improve quality and efficiency.

Skills

Protein purification techniques

Write and revise technical documents

Follow detailed instructions

Team environment

Problem solving

Operate production equipment

Lift up to 30 lbs

Education

High School Diploma or equivalent

Associate degree

Bachelor’s degree in related discipline

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 DutiesParticipates 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 & ExperienceHigh 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.ORAssociate degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.ORBachelor’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-$75,000Compensation and BenefitsWe offer a comprehensive benefits package designed to support our employees’ wellbeing, including:Competitive salary and performance-based incentivesComprehensive health coverage including medical, dental, and vision insuranceRetirement savings plans with employer matching contributionsPaid time offProfessional development opportunitiesEmployee wellness programs and resourcesEmployee Assistance Program and Mental Health ResourcesCore ValuesAt 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.