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ADMA Biologics, Inc. · 1 month ago

Senior Scientist, Production Operations

Boca Raton, FL

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The Senior Scientist, Production Operations will lead and provide technical support for departmental projects, drive process improvements, and support a strong cGMP environment.

BiotechnologyHealth CareManufacturingMedical

No H1B

Responsibilities

Develop subject matter expertise in biologic protein fractionation, purification, and fill finish technologies to support Production Operations

Technical lead for all departmental projects, change controls, risk assessments, deviations, CAPAs, and audit support

As needed provide data/analysis to support groups including: MQA, PD, Regulatory Affairs, Microbiology, Engineering and Validation

Utilize project management skills to track progress of projects to ensure milestones are met

Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set and communicate status on a routine basis

As needed analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control

Support the development of training strategies and materials for manufacturing and support teams as needed

Work closely with department leaders and peers and interfaces to fill in for leaders and peers as required

Partner with support functions to continuously improve safety and quality to meet ADMA goals

Stay current on industry trends

Qualification

Biologic protein fractionationPurification technologiesFill finish operationsProject managementCGMP complianceFDA regulationsLean manufacturingSix SigmaInterpersonal skillsOrganizational skillsCollaborative skillsLeadership skills

Required

10+ years of experience in Plasma Fractionation or Purification or Fill Finish Operations

Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel at all levels

Must be able to work and facilitate a team-orientated environment

Must have demonstrated project management skills and/or project delivery skills

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

FDA Adherence

Strong organizational, interpersonal and collaborative skills

Preferred

Bachelor's degree in science, engineering, or another related technical field preferred

Experience in all aspects of Manufacturing preferred

Knowledge of world-class manufacturing methods (QLP, Lean, Six Sigma), DMAIC, Good Manufacturing Practices, Food and Drug Administration regulations

Benefits

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

Company

ADMA Biologics, Inc.

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.

Founded in 2004

Ramsey, New Jersey, USA

501-1000 employees