BioProcess Associate

Bora Pharmaceuticals•Baltimore, MD

9d•$52,000 - $78,000

About The Position

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summary Perform preparation and filling of parenteral pharmaceuticals in accordance with cGMP regulations. Responsible for setup and operation of equipment and processes associated with sterile filling processes. Responsible for daily cleaning and sanitization activities throughout the production area. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Work under general supervision of more experienced Technicians or Manufacturing Supervisors to produce parenteral drugs. Comply with cGMP regulations, adhere to established policies, SOP and Batch Record directions. Report any unexpected observations and suggest possible explanation and resolution Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed. Independently set up, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the aseptic core, in accordance with current industry, client, and established standards. Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client. Assist the Validation and Maintenance staff with the operation and execution of engineering projects. Conduct training sessions for less experienced Technicians to ensure a high level of effectiveness and quality is met during production operations. Perform housekeeping, plant upkeep, and sanitization activities throughout the production area as required. Prepare, clean, or sterilize equipment as necessary for routine aseptic operations Restricted Access Barrier System (RABS): Maintain proper gowning qualifications necessary for routine aseptic operations, including filling operations, cleaning of ISO 5/6 areas, and loading/unloading Terminal Sterilization autoclaves and Lyophilizers. Isolator: Maintain proper gowning qualifications; Demonstrate aseptic technique and able to conduct cleaning activities in a clean room 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.

Requirements

BA/BS in any field Or High School/AA with at least 3 years of experience in a GMP environment
Ability to work independently with minimal guidance and as part of a team
Experience using computer applications, including data statistical, word processing, spreadsheet, and presentation software.

Nice To Haves

Experience in filling using Restricted Access Barrier (RABs) or Filling Isolator Technology.
Experience in preparation of material or equipment in a clean room environment.
Experience in operating Vial Washers, Sterilizing Autoclaves, or Sterilizing ovens.

Responsibilities

Perform preparation and filling of parenteral pharmaceuticals in accordance with cGMP regulations.
Responsible for setup and operation of equipment and processes associated with sterile filling processes.
Responsible for daily cleaning and sanitization activities throughout the production area.
Work under general supervision of more experienced Technicians or Manufacturing Supervisors to produce parenteral drugs.
Comply with cGMP regulations, adhere to established policies, SOP and Batch Record directions.
Report any unexpected observations and suggest possible explanation and resolution
Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed.
Independently set up, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the aseptic core, in accordance with current industry, client, and established standards.
Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
Conduct training sessions for less experienced Technicians to ensure a high level of effectiveness and quality is met during production operations.
Perform housekeeping, plant upkeep, and sanitization activities throughout the production area as required.
Prepare, clean, or sterilize equipment as necessary for routine aseptic operations
Maintain proper gowning qualifications necessary for routine aseptic operations, including filling operations, cleaning of ISO 5/6 areas, and loading/unloading Terminal Sterilization autoclaves and Lyophilizers.
Maintain proper gowning qualifications; Demonstrate aseptic technique and able to conduct cleaning activities in a clean room environment.