Manufacturing Associate III - Production Support

Bora Pharmaceuticals; Rockville (MD); On-site; USD 88,000 - 115,000; Full time

Benefits offered by this job

Competitive salary

Performance incentives

Health coverage

Retirement plan

Paid time off

Professional development

Wellness program

EAP & Mental Health

Job summary

Bora Biologics in Rockville, MD seeks a Manufacturing Associate III – Production Support to assist in making materials for clinical programs under cGMP. Responsibilities include weigh/dispense, buffer/media prep, cleaning, and equipment operation in a GMP environment.

You will draft GMP documents, monitor records, and collaborate with QA/QC to ensure quality manufacturing processes. Flexibility for overtime may be required.

Qualifications

• FDA-regulated, controlled production environment experience preferred.
• Ability to draft and revise GMP documents and reports.
• Experience supporting manufacturing of biopharmaceuticals.

Responsibilities

• Perform weigh and dispense, buffer prep, media prep, and cleaning in GMP area.
• Operate bioprocess equipment and maintain calibration of lab devices.
• Prepare materials for cleanroom use and maintain records
• Draft SOPs, Work Instructions, and deviation reports as needed.
• Coordinate sample testing and room release with QC/QA.

Skills

Chemistry knowledge

Mentor and train others

Team player

Organizational skills

Documentation writing

Data analysis

Equipment operation

Problem solving

Continuous improvement

Manual dexterity

Communication

Education

High School Diploma or equivalent

Associate’s degree

Bachelor’s degree

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 III – Production Support participates in the preparation of solutions used to manufacture biopharmaceutical drug substance to support Bora Biologics multiple clinical programs. This position will work in the manufacturing suite under cGMP (Current 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 DutiesPerform support tasks that enable the manufacturing of material for clinical trials in a GMP manufacturing environment, including weigh and dispense, buffer prep, media prep, facility cleaning, equipment cleaning, and raw material ordering in compliance with all SOPS and GMP regulations.Operate bioprocess equipment, balances, downflow booths, mixers, and pumps under strict adherence to cGMP, OSHA and required policies and regulations.Maintain appropriate inventory of chemicals and consumables by ensuring the timely and accurate planning of raw material required and order as needed.Prepare (wipe down) materials and equipment for use in cleanroom environment in accordance with procedures.Draft and revise Solution Records, Work Instructions, Standard Operating Procedures and other GMP documents and reports related to the support work with minimal supervision. Write deviation/incident reports as needed.Execute solution records under GMP regulations and related SOPs. Document all manufacturing activities clearly and accurately, including preparation records, testing records, and equipment use records.Prepare and maintain reports and other documentation as applicable to the scope of operations in the manufacturing facility.Collaborate with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes. Coordinate sample testing and room release with the Quality Control group.Monitor, maintain and calibrate laboratory equipment as needed. Assist with technical issues and problems and identify solutions and improvements.Conduct basic troubleshooting of technical issues and other problems encountered within the solution preparation process and equipment. Make recommendation for short term and long-term resolution.Monitor and audit work processes to ensure compliance and completion of targets. Identify areas for improvement in manufacturing efficiencies and compliance and make recommendations to supervisor.Assist with technology transfer from Process Development to manufacturing environment.Organize projects and data using Excel, Word, PowerPoint and a document control system.Maintain a clean and safe plant environmentThe 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 and a minimum of five years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environmentORAssociate’s degree in a related discipline and a minimum of four years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environmentORBachelor’s degree in a related discipline and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environmentPrior experience following GMP rules and proceduresKnowledge, Skills and Abilities• Knowledge of basic chemistry• Ability to mentor and train others• Engaged and committed team professional who is committed to generating quality products and professional work ethic driven by manufacturing timelines.• Strong organizational skills and attention to detail and ability to manage multiple projects.• Ability to write and revise technical documents concisely and clearly.• Technical accuracy and ability to perform mathematical calculations.• Ability to safely operate production equipment in accordance with established practices.• Critical thinker who can analyze data and respond quickly to manage manufacturing projects.• Passion for continuous improvement• Independent thinker and self-learner• Manual dexterity• Strong interpersonal skills and the ability to work effectively and efficiently in a team environment.• Ability to work flexible hours, including possible overtime and weekends.• Ability to lift-up to 30 lbs Salary Range:$88,000-$115,000Compensation 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.