Reagent Manufacturing Associate

Summary

Bionano is looking for a talented, versatile Reagent Manufacturing Associate that will support all areas of consumables production, primarily sample and reagent formulation. This position will specialize in recovering and preparing megabase-long DNA to run on the Saphyr and Stratys platforms. This position requires meticulous attention to detail and ability to follow and repeat a protocol precisely and consistently. The candidate must be a fast learner, well-organized and have excellent communication skills and work well with a team. This position is based in our San Diego headquarters.

Primary Duties and Responsibilities

• Prepare cell culture and samples to support labeled and unlabeled DNA samples for use in research, product development, production, and field service (50%).
• Produce reagents and consumables following manufacturing batch records and standard operating procedures (25%).
• Prepare kit and package reagents and consumables (5%).
• Prepare reagent standard operating procedures and batch records and conduct in-process and final testing of reagents and consumables (5%).
• Control and maintain inventory of reagent materials in formulation lab (5%).
• Validate new and existing equipment and perform general maintenance and/or calibration and cleaning of all formulation equipment and space (5%).
• Other duties as assigned (5%).

Required Skills and Abilities

• Experience with GMP compliant documentation systems. Able to read, understand, and adhere to Standard Operating Procedures, cGMP’s (current Good Manufacturing Practices), and other government regulations.
• Able to be accurate, attentive to details, and to work with limited supervision and independently or within a team environment.
• Proficient computer skills and good working knowledge of Microsoft Office programs (Word, Excel) and general database usage.
• Experience with sterile techniques and accurate pipetting skills.
• Ability to perform tasks that are monotonous & physically demanding in lab environment (e.g. repetitive pipetting, labeling, and capping/uncapping tubes).

Education, Certifications, Licenses

• Education (Level and field of study) required: Bachelor’s degree in scientific discipline, preferably in biology molecular biology, or biochemistry.
• Years relevant/ total work experience: 0-1 year of experience in reagent formulation in a cGMP production environment.
• Certifications required/ preferred: N/A

Leadership Responsibility (Direct/ Indirect): N/A

Additional Requirements

• Work Location: San Diego, CA onsite
• Travel Requirements: N/A
• Physical Requirements and Work Environment:
• Sit and stand for prolonged periods
• Repeating motions that may include the hands, wrists and/or fingers
• Use of hands to finger, handle, or feel, and reach with hands and arms
• Stand and/or move about the office or in various environments (including tight and confined spaces), or from one worksite to another
• Specific visual abilities, including close vision and ability to adjust focus, read, review, and assess the accuracy and thoroughness of the work assigned
• Verbal abilities require communicating with others to exchange information
• Occasionally adjusting or moving objects up to 50 pounds in all directions
• Work environment involving low/high temperatures; hazardous conditions, low ventilation, noisy environments, small/enclosed spaces
• In-person interaction with others indoors and outdoors
• Use standard computer, telephone and related equipment for communication, and recordkeeping.

The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on the Company.

Disclaimer

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.