Group Leader, Fractionation

ADMA BIOMANUFACTURING LLC

$75K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • High school diploma required.
  • Minimum 2 years of experience in fractionation or a similar field.
  • Strong knowledge of CGMP guidelines and FDA regulations.
  • Proven ability to manage workloads efficiently.
  • Experience in training and mentoring staff.

Responsibilities

  • Oversee pharmaceutical manufacturing in compliance with CGMP standards.
  • Maintain a clean, safe working environment for the team.
  • Evaluate and assign daily tasks to technicians effectively.
  • Prioritize production tasks to meet stringent deadlines.
  • Ensure accurate completion of logs and batch records.
  • Troubleshoot production issues to prevent delays.
  • Order materials timely to support production flow.

Benefits

  • 401K plan with employer match and immediate vesting.
  • Comprehensive medical, vision, life, and dental insurance.
  • Pet insurance coverage available.
  • Company-paid short-term and long-term disability insurance.
  • Paid holidays and 3 weeks of PTO within the first year.
  • Tuition assistance after the first year of employment.
  • Convenient access to Tri-Rail with free shuttle service.
Full Job Description
Job Title: Group Leader, Fractionation

Job Description:

Position Summary

The role is responsible for overseeing the manufacture of pharmaceutical products. This includes evaluating workloads and job assignments, scheduling work to meet deadlines, training employees, and troubleshooting when required.

Essential Functions (ES) and Responsibilities

  • Oversee the manufacture of pharmaceutical products within CGMP guidelines.
  • Maintain a clean and safe working environment.
  • Evaluate workload and assign tasks to technicians daily.
  • Prioritize work based on production schedule and meet deadlines.
  • Ensure all appropriate logs and batch records are completed accurately and on time.
  • Troubleshoot work-related problems to ensure that delays are avoided.
  • Order materials needed for production promptly so that adequate supplies are available to avoid production delays.
  • Participate in training of employees.
  • Ensure process areas are sanitized to meet room specifications
  • Perform minor maintenance work on some equipment.
  • Perform shift changeover between shifts.


Job Responsibilities or Job Requirements

Competencies

FDA Adherence

Experience Requirements

  • Education Requirements: High school diploma.
  • Experience Requirements: A minimum of 2 years in a fractionation or related field.


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.

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

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