Manufacturing Technician

SCOPE OF RESPONSIBILITY:
The Tech positions will be the primary entry point for GMP Manufacturing of biologics at the Carlsbad site. Differentiation on Tech level will be based on experience levels in GMP Manufacturing at both the Carlsbad site and at external locations. These positions do not have supervisory responsibility. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees will have no specific decision-making authority as they are asked to follow GMP batch records. Employees are expected to prepare suites for manufacturing, to document deviations, and to operate in a safe manner for the employee, others in the GMP Manufacturing suites, and for the Product being manufactured.
PURPOSE OF THE POSITION:
The Manufacturing Technician in the Operations department is responsible for performing cGMP biopharmaceutical cell culture, buffer and medium preparation, membrane clarification, membrane concentration and buffer exchange, column purification, terminal filtration, Fill and Finish, stocking supplies and raw materials, and cleaning process equipment. They perform all their GMP operations with supervision as necessary. Manufacturing Technicians are progressively developing competency in cGMP manufacturing of biopharmaceuticals and will be trained towards proficiency in all production unit operations.

Education:
Bachelor of Science degree or equivalent work experience.

Experience: Minimum of 3 years of directly related experience.

Essential and Critical Skills:

Knowledge of biology and chemistry

Knowledge of relevant unit operations.

Sterile cell culture

Disposable bioreactors (25 to 100L, Wave, SUB) / viral vector manufacturing

Disposable clarification / filtration (pharmaceutical unit operations)

Ultrafiltartion / Diafiltration

GE Process Skid operation / column chromatography / column packing

Bulk Drug Formulation and dilution

Sterile Fill / Finish

Working knowledge of desktop computers and technical equipment

ADDITIONAL LOCAL NEEDS

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.

• The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

• The employee must be able to work off-shifts, weekends, and additional hours as required.

• The employee must have the ability to perform moderately physical activity.

• The employee must have the ability to perform very complex tasks with attention to detail.

• The employee must be self motivated, work well in a group, and communicate well with all levels of the operations team.

Kind Regards,

Sasha Sharma

732-662-7964

Integrated Resources, Inc.