Technician I, Process Development

ADMA Biologics; Boca Raton, Northern (FL, KY); Hybrid; USD 60,000 - 80,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental

Pet Insurance

Company Paid Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to Boca Tri-Rail

Job summary

ADMA Biologics is seeking a Technician I, Process Development in Boca Raton, FL. The role focuses on conducting lab and pilot-scale experiments to support new technologies and improved manufacturing processes.

The technician will assist in scalable process development, data collection and analysis, and ensure compliance with FDA regulations and cGMP standards. The position requires a BS in a relevant science and up to two years of lab experience.

Qualifications

• B.S. in Microbiology, Chemistry, Biochemistry, Biology, or related field required.
• Up to two years in a laboratory setting; regulated environment experience preferred.
• Excellent documentation, organization, and communication skills; proficiency with MS Word/Excel/LIMS.

Responsibilities

• Conduct lab scale studies and plasma protein processing.
• Perform lab and pilot-scale experiments to develop new technologies.
• Operate centrifuges, filtration, and chromatography systems; monitor with pH meters and spectrophotometer.
• Ensure adherence to FDA regulations and cGMP practices.
• Prepare samples, data entry, and documentation for procedures and tests.

Skills

Lab techniques

Data analysis

Pipettes

Centrifugation

Education

BS in Microbiology/biochemistry

Tools

Spectrophotometer

pH meter

LIMS

Job description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Technician I, Process Development in Boca Raton, Florida!

Job Title: Technician I, Process Development

Job Description:

Position Summary

The Technician I, Process Development, conducts laboratory and pilot-scale experiments that support the development of new technologies. Partially responsible for the optimization of manufacturing processes and implementation of regulatory requirements. Assists in process development activities, creates scalable processes with improved product yield and reduced manufacturing systems costs. Researches and assists with the implementation of new methods and technologies to enhance operations. Collects, analyzes, interprets and data to improve processes.

Essential Functions (ES) and Responsibilities

• The standard schedule for this position is 8:00 AM to 5:00 PM, but employees may frequently be required to work 12-hour rotating shifts during operational campaigns and manufacturing model runs.
• Conducts lab scale studies that include processing of plasma proteins.
• Conducts laboratory and pilot-scale experiments to evaluate and develop new technologies.
• Operation of centrifuges, filtration apparatus, and chromatography systems
• Routine use of monitoring instruments such as pH/ conductivity meters, spectrophotometer, and scale
• Routinely performs sample and buffer preparation including labeling.
• Equipment and Area cleaning
• Completes documentation and data entry as required for procedures and tests performed.
• Adheres to Safety and cGMP practices in execution of job functions.
• Performs testing as needed to generate data for validation and special projects.
• Fulfills requests from management for assistance in other matters as needed.
• Assists in creating scalable processes.
• Assists the manufacturing operations team in problem solving with regard to equipment and systems.
• Participates in the design and start-up of new manufacturing facilities and equipment.

Competencies

Possess time management skills and be able to balance multiple job assignments at once Possesses strong organizational, critical thinking, reasoning, and problem-solving abilities. Strong organizational, interpersonal and collaborative skills

Experience Requirements

• Education Requirements: B.S. in Microbiology, Chemistry, Biochemistry, Biology, or related scientific discipline required.

• Experience Requirements: Requires up to two years of experience in a laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc) is preferred. Must have the capacity to work at small scale and to transfer to larger applications. Must be familiar with basic lab equipment (pH meter, spectrophotometer, scale, pipettes, pumps, etc.) Requires computer skills (MS Word, Excel, LIMS, etc). Requires excellent organizational skills, and the ability to interact effectively with internal and external colleagues and managers.

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensivebenefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet InsuranceCompany paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .

ADMA Biologics is an Equal Opportunity Employer.