Senior Manager, Analytical Development

Job Description Header:

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 Senior Manager, Analytical Development in Boca Raton, FL!

The Senior Manager, Analytical Development will support the development of analytical methods.

Job Title: Senior Manager, Analytical Development

Job Description:

Position Summary

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 Senior Manager, Analytical Development in Boca Raton, FL!

The Senior Manager, Analytical Development demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Essential Functions (ES) and Responsibilities

• The Senior Manager will be responsible to direct the work of analytical development scientists.
• Oversees day to day operations of the analytical development team.
• Plans for future project including budget and timelines.
• Ensures project timelines are met.
• Serves as a process and scientific subject matter expert.
• Ensures compliance with cGMP process, training, procedures.
• Responds to reports from internal/external audits.
• Directs validation, development, and qualification studies and reports.

Job Responsibilities or Job Requirements

Competencies

Ability to effectively manage staff. Ability to handle multiple priorities and tight deadlines. Understand concepts, requirements, and accounting issues for all business areas

Ability to follow the cGMP's and procedures with great attention to detail

Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures

Able to work in high-pressure, deadline-driven environment

Actively provides feedback to operations management and staff regarding staff performance against SOPs. Works to develop and maintain a collaborative and effective working relationship with operations management

Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines

Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs

Must be able to prepare, deliver spreadsheets, data analysis, presentations and facilitate for small and large groups

Must be independent and able to design experiments, processes, thinking critically with vision, and is responsible to analyze data and make recommendations to senior management regarding process improvements and development

Possess time management skills and be able to balance multiple job assignments at once

Possesses strong organizational, critical thinking, reasoning, and problem-solving abilities.

Protein purification

Strong organizational, interpersonal and collaborative skills

Experience Requirements

Education Requirements:

• Master's degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
• Bachelor's degree and 12 years of process development experience.

Experience Requirements:

• 10 plus years of experience developing protein purification processes.
• Minimum of 2 years of experience in a GMP environment.

Other Essential Knowledge:

• Protein biochemistry, especially immunoglobulin chemistry.
• Assay development.
• Assay validation.
• GMP method development and validation.
• Technical transfer of methods.

Preferred Experience

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.

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

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company 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-Rail
• Free 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.

Job Description Footer:

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

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company 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-Rail
• Free 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.

Apply now