Management
ADMA Biologics FL - Boca Raton, FL
N/A
Full Time
Graduate Degree
Undisclosed
Undisclosed
Undisclosed
Pharmaceutical
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 an
The will support the development of analytical methods and programs for analytical development.
:
- Responsible for developing new or improved analytical development methods and processes
- Lead project teams and direct reports
- Independently design, execute, analyze studies, under the direction of senior management
- Remain current on developments in the field and relevant guidance (ICH and USP)
- Mentor scientists as they need assistance in experimental design, make recommendations to management, analyze project goals and criteria to ensure they are scientifically sound and meet the business needs of all key stakeholders
- Manage stakeholders and interface with departments such as PD, Manufacturing, RA, Quality, as appropriate
- Demonstrate strong technical expertise and provide business centered, innovative solutions to process improvement and development initiatives
- Excellent written and oral communication skills
- Statistical analysis for analysis and interpretation of data
- Serve as a technical expert for analytical development and validation or analytical methods
- Master's degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline
- Bachelor's degree and 12 years of biologics or analytical development experience
- 10+ years of experience developing biologics processes or analytics and designing protocols.
- 3+ years of experience in a GMP environment
- 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
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.
is an Equal Opportunity Employer
What We Do
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates.