Manufacturing Associate I – Cell Culture
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegmpcdmfdainformaws
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 Cell Culture 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 Participate in hands-on production in the manufacturing of material for clinical trials in a GMP environment, including operating expansion and production reactors, conducting harvest operations, and ordering and accounting for consumption of raw materials and components. Contribute to the creation and revision of Batch Records, Work Instructions, Standard Operating Procedures, Material Specifications and other GMP documents. Adhere to all SOPs and execute batch records under GMP regulations documenting all manufacturing activities clearly and accurately, including preparation records, testing records, equipment use records, and laboratory notebooks. Maintain adequate supplies and perform routine equipment maintenance. Maintain manufacturing area in a clean, neat, and orderly condition at all times. Participate in a variety of projects designed to improve the quality, and efficiency of the manufacturing team. Follow all related safety rules 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 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 cell culture techniques Ability to write and revise technical documents Ability to lift up to 30 lbs. Ability to work occasional weekends or overtime as needed Ability to follow detailed instructions and to maintain accurate records and notes 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 practices 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.
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