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GBI Bio · 1 month ago

QCA Analytical Scientist II, Team Lead

Fort Lauderdale, FL

Full-time

Onsite

Senior Level

5+ years exp

GBI Bio is a company focused on biotechnological advancements, and they are seeking a QCA Analytical Scientist II, Team Lead. The role involves overseeing data analysis for product tech transfers and assay verifications while providing analytical support and leading day-to-day laboratory activities.

BiopharmaBiotechnologyProduct Research

Responsibilities

Oversee execution of and review data analysis for Client product tech transfers and assay verifications for the Protein Characterization team

Provide analytical support testing, as needed, to Upstream Processing, Downstream Processing and Bioconjugation groups

Collaborate with Quality Control in performing method transfers as well as with troubleshooting existing qualified/validated assays

Support PD'in evaluating product stability and monitoring degradation pathways

Generate Experimental Plans'imd Project Summary reports as needed

Serve as in-lab leader and help direct day-to-day test planning activities

Perform Protein Characterization, Routine Testing or In-Process Support testing as required including ELISA, SOS PAGE, IEF, HPLC, Western Blot, BCA, Capillary Electrophoresis, cell-based assays, spectrophotometric, spectrotluorometric and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards in support of tech transfer and process development activities

Evaluate emerging techniques in protein characterization for the production of biotherapeutics and develop assay as required

Assist PC teammates in troubleshooting assay optimization difficulties

Direct day-to-day PC-related laboratory activities and ensure that experimental plans are being followed

Be responsible for data review and data collaboration for assay projects

Work collaboratively and communicate data with department head as well as other involved parties

Communicate directly with Scientist II counterparts for various Clients during the project onboarding and initiation stage

Act as SME for commonly performed analytical methods

Create and/or Review of technical reports such as SOPs, experimental plans, interim project status reports and summary reports

Be prepared to optimize and troubleshoot new assays using sound scientific judgement with approval of department head

Assist in onboarding and document creation for new instrumentation in the PD Lab

Perform PD Lab inventory checks

Create and manage Purchase Order requests for new projects

Record laboratory activities and results in appropriate notebooks

Assist Quality Control group in troubleshooting assays, where appropriate

Effectively interact and assist other groups within the Development groups (Cell Culture, Protein Purification, and Bio-Conjugation) and the Quality/Regulatory and Manufacturing groups on assay, and process related matters

Manage multiple projects

Demonstrate high attention to detail and proven track record of organizational excellence

Demonstrate strong problem-solving skills

Strong oral and written communication skills

Train on and become familiarized with all pertinent analytical techniques

Qualification

Protein CharacterizationHPLCELISATechnical WritingLeadership skillsProblem-solving skillsCommunication skillsOrganizational skills

Required

Evaluate emerging techniques in protein characterization for the production of biotherapeutics and develop assay as required

Assist PC teammates in troubleshooting assay optimization difficulties

Direct day-to-day PC-related laboratory activities and ensure that experimental plans are being followed

Be responsible for data review and data collaboration for assay projects

Work collaboratively and communicate data with department head as well as other involved parties

Communicate directly with Scientist II counterparts for various Clients during the project onboarding and initiation stage

Act as SME for commonly performed analytical methods

Create and/or Review of technical reports such as SOPs, experimental plans, interim project status reports and summary reports

Be prepared to optimize and troubleshoot new assays using sound scientific judgement with approval of department head

Assist in onboarding and document creation for new instrumentation in the PD Lab

Perform PD Lab inventory checks

Create and manage Purchase Order requests for new projects

Record laboratory activities and results in appropriate notebooks

Assist Quality Control group in troubleshooting assays, where appropriate

Must be able to manage multiple projects

Demonstrate high attention to detail and proven track record of organizational excellence

Demonstrate strong problem-solving skills

Strong oral and written communication skills

Train on and become familiarized with all pertinent analytical techniques

BS or MSc in Biological or Biochemical sciences, and 5+ years relevant laboratory experience in antibody/protein characterization or quality control - particularly in the areas of immunology, molecular and cell biology, and protein chemistry

2+ years' experience in Technical Writing

Leadership skills

Preferred

Previous CRO/CDMO experience is a plus

Company

GBI Bio

GBI, based near Fort Lauderdale, Florida, is a fully integrated, customer-focused cGMP Contract Development Manufacturing Organization (CDMO) of Biosimilar and innovative monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other bioconjugates.

Founded in 1992

Plantation, Florida, USA

51-200 employees