Process Development Group Leader
Company: ADMA Biologics
Location: Boca Raton
Posted on: May 14, 2022
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 Process Development Group Leader in Boca Raton, FL!
The incumbent will provide process development support for IgG
Immunotherapy Production. They will provide updates to Process
Development (PD) Management team on a regular basis to ensure
compliance issues are being met. Responsible for maintaining
compliance in PD laboratory and executing process
development/evaluation studies as well as process validations using
a scale down model. Providing supervision of PD Technician(s). As a
key member of the PD group provide support for Manufacturing,
Quality Control/Quality Assurance, and Regulatory departments.
- Oversee/supervise routine PD activities utilizing the validated
scale model. Oversee/supervise activities in single or multiple
unit operations for PD studies. Record results in BPR utilizing the
- Provide support for technical issues related to the
manufacturing process and product quality.
- Write/Revise/Review Batch Production Records as necessary.
- Maintain compliance in PD laboratory by ensuring all equipment
calibration/IQ/OQ/PM status are current.
- Participate in designing and planning scientific experiments to
achieve corporate goals for existing projects.
- Review and/or approve cGMP documentation (BPR) generated by
other PD group members as necessary.
- Maintain and review process development Batch Records for scale
down process models.
- Perform other activities as assigned by the PD Managers.
- Assist manufacturing personnel in the execution of process
development and process validation studies in cGMP production
environment as necessary. QUALITY SYSTEMS:
- Write/Revise/Review Standard Operating Procedures within the PD
group as per cGXP guidelines.
- Write/Review Quality System Documents for Deviations, Change
Controls, CAPAs, etc. as necessary. HEALTH and SAFETY:
- Maintain ADMA Safety Initiatives for the PD Lab
- Maintain a clean and safe working environment
- Ensure compliance following Safety Rules GROUP LEADER
- Evaluate workload and assign tasks to direct reports on a daily
- Prepare yearly evaluations of direct reports
- Ensure direct reports compliance on all ADMA Safety, Quality
and PD initiatives QualificationsEducation Requirements: Bachelor's
degree in Science or Engineering. Experience Requirements: At least
ten (10) years experience in a cGMP, Pharmaceutical/Biological
manufacturing environment, familiarity with many aspects of process
development is expected. Knowledge of FDA cGMP requirements is an
essential pre-requisite for this position. Other Essential
Knowledge: Ability to coordinate and complete complex projects;
proficient in Microsoft Word, Excel, Power Point and Project;
possess effective skills for developing, performing, evaluating,
and/or troubleshooting; detail oriented, and excellent mathematical
skills; Ability to plan and manage own work and performs other
duties, responsibilities and projects as assigned. In addition to
competitive compensation, we offer a comprehensive benefits package
- 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
- Company paid shuttle to the Boca Tri-Rail station ADMA
Biologics, Inc. 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 . ADMA
Biologics is an Equal Opportunity Employer
Keywords: ADMA Biologics, Boca Raton , Process Development Group Leader, Other , Boca Raton, Florida
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