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 Duties

• Perform 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 environment

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 and a minimum of five years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• OR
• Associate's degree in a related discipline and a minimum of four years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• OR
• Bachelor's degree in a related discipline and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• Prior experience following GMP rules and procedures

Knowledge, 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-$115,000

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