Manufacturing Associate I – Production Support

Bora Pharmaceuticals; Rockville (MD); On-site; USD 60,000 - 62,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

Retirement plan with employer matching

Paid time off

Professional development opportunities

Employee wellness programs

Job summary

Bora Pharmaceuticals is seeking a Manufacturing Associate I to support clinical program manufacturing in a GMP environment in Rockville, MD. You will prepare solutions, document processes, and maintain equipment, ensuring compliance and quality throughout production.

Ideal candidates have a strong chemistry foundation, strong attention to detail, and ability to work in a team with safety-first mindset. The role includes lifting up to 30 lbs and potential overtime as needed.

Qualifications

• Education and hands-on experience in biopharmaceutical manufacturing or FDA-regulated environments.
• Ability to write and revise technical documents concisely and clearly.
• Ability to follow detailed instructions and maintain accurate records.
• Experience with GMP practices and safe handling of hazardous materials.
• Comfort with lifting up to 30 lbs and occasional overtime.

Responsibilities

• Performs manufacturing support tasks for clinical program material in GMP environment.
• Prepare and test solutions, weigh materials, and coordinate sample collection.
• Create and revise solution records, work instructions, and SOPs.
• Maintain inventory, perform routine equipment maintenance, and document activities.
• Collaborate with QA to ensure compliance and product quality.

Skills

Basic chemistry

Technical writing

Mathematical calculations

Attention to detail

Teamwork

Safety awareness

Critical thinking

Equipment operation

Physical stamina

Education

High School Diploma or equivalent

Associate's degree

Bachelor's degree in a related discipline

Tools

Excel

Word

PowerPoint

Document control system

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 Production Support area. This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) and produce materials necessary for executing the manufacturing process ensuring compliance with all required specifications and regulatory requirements.ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Performs support tasks that enable the manufacturing of material for clinical trials in a GMP manufacturing environment, including planning, communicating daily material needs, weighing materials, preparing and testing solutions, coordinating sample collection and submission, facility cleaning, equipment cleaning, material ordering, and routine consumption of raw materials and component transactions within our electronic management system.Creates and revises Solution Records, Work Instructions, Standard Operating Procedures and other GMP documents related to the support work.Reviews cleaning logbook forms for accuracy.Cleans and disinfect materials that enter the manufacturing suite.Prepares solutions, completes solution records, and reviews solution records under GMP regulations and related SOPs. Documents all manufacturing activities clearly and accurately, including preparation records, testing records, and equipment use records.Works in collaboration with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.Maintains chemical and supplies inventory and performs routine equipment maintenance and housekeeping ensuring that equipment and materials are available and adequate to set the manufacturing team up for success.Participates in a variety of projects, as assigned, designed to improve the service, quality, and efficiency of the production support team.Operates bioprocess equipment (Single Use Mixers, TOTE Tanks, Mixers, Scales) under strict adherence to cGMP, OSHA and required policies and regulations.Follows all related safety rules and procedures when working with hazardous materials to maintain a clean and safe plant environment.Organizes projects and data using Excel, Word, Powerpoint and a document control system.Requests Master Batch Records from Quality Assurance Document ControlPerforms other activities assigned by area supervisorThe 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.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 environmentORAssociate’s degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environmentORBachelor’s degree in a related discipline with no experienceKnowledge, Skills and Abilitie sKnowledge of basic chemistryAbility to write and revise technical documents concisely and clearlyTechnical accuracy and ability to perform mathematical calculationsAbility to follow detailed instructions and to maintain accurate records and notesStrong organizational skills and attention to detailAbility to work effectively in a team environment while demonstrating a commitment togenerating quality productsProfessional work ethic driven by manufacturing timelines and passion for continuousimprovementAbility to think critically, analyze data and respond quickly to manage multiple manufacturing projectsSkilled in problem solving and troubleshootingAbility to safely operate production equipment in accordance with established practicesAbility to lift up to 30 lbs.Ability to work occasional weekends or overtime as needed Salary Range:$60,000 - $62,000Compensation 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.