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

Incentives

Health coverage

Retirement plan

Paid time off

Professional development

Wellness programs

Employee assistance

Job summary

Bora Pharmaceuticals is seeking a Manufacturing Associate I to support the production of biopharmaceutical drug products in a GMP environment. The role involves preparing materials, executing manufacturing steps, maintaining records, and coordinating with QA to ensure compliance with regulatory specifications.

The position emphasizes accuracy, safety, and teamwork within a fast-paced production setting, with the potential for professional development and involvement in multiple clinical programs.

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
• Associate's degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• Bachelor's degree in a related discipline with no experience

Responsibilities

• Plan and communicate daily material needs and weigh materials for manufacturing
• Prepare and test solutions; coordinate sample collection and submission
• Maintain cleaning of the facility and equipment; assist with inventory and material transactions
• Create and revise GMP documents including Master Batch Records, Work Instructions, and SOPs
• Review cleaning logbooks for accuracy and ensure compliance with GMP
• Collaborate with Quality Assurance to meet quality goals; maintain accurate records

Skills

Basic chemistry

Technical writing

Math calculations

Record keeping

Team collaboration

Quality focus

Problem solving

Equipment operation

Safety awareness

Education

High School Diploma or equivalent

Associate's degree

Bachelor's degree (related field) with no experience

Tools

Excel

Word

PowerPoint

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 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 FUNCTIONS

Reasonable 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 Control
• Performs other activities assigned by area supervisor

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.

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's 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 basic chemistry
• Ability to write and revise technical documents concisely and clearly
• Technical accuracy and ability to perform mathematical calculations
• Ability to follow detailed instructions and to maintain accurate records and notes
• Strong organizational skills and attention to detail
• Ability to work effectively in a team environment while demonstrating a commitment to
• generating quality products
• Professional work ethic driven by manufacturing timelines and passion for continuous
• improvement
• Ability to think critically, analyze data and respond quickly to manage multiple manufacturing projects
• Skilled in problem solving and troubleshooting
• Ability to safely operate production equipment in accordance with established practices
• Ability to lift up to 30 lbs.
• Ability to work occasional weekends or overtime as needed

Salary Range: $60,000 - $62,000

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, stride 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.