Robert Nelson Email & Phone Number

Cottage Grove, Mn, Us

Greater Minneapolis-St. Paul Area

Lead Analyst for Transdermal Drug Delivery programs. Provide leadership to analytical team in support of partner-funded and self-funded TDD programs.Highlights:• Assure completion of all tasks by analytical team in preparation of Early Feasibility development programs, Proof of Concept and BE Equivalence clinical studies, and responses to deficiencies outlined in FDA Complete Response Letters or Requests for Information.• Execute, or oversee, development of methods for drug and excipient content, residual solvents and residual monomers, release rate and physical tests in transdermal formulations.• Perform method validation, appropriate to phase of project.• Lead transfer of analytical methods to QC laboratory at Northridge CA manufacturing site.• Implement partner-developed methods within St. Paul Development Laboratory.• Provide direction to Kindeva and contract personnel on the Analytical team.• Serve on multi-function project teams, and Joint Technical Teams (including partner), including giving presentations of analytical data to partner.• Support in preparation of ANDA submissions.• Leadership in preparation of responses to Complete Response Letters (CRL) from FDA.

3M Center, St. Paul Mn

Lead Analyst for Transdermal Drug Delivery programs. Provide leadership to analytical team in support of partner-funded and self-funded TDD programs. Highlights:• Assure completion of all tasks by analytical team in preparation of Early Feasibility development programs, Proof of Concept and BE Equivalence clinical studies, and responses to deficiencies outlined in FDA Complete Response Letters or Requests for Information.• Execute, or oversee, development of methods for drug and excipient content, residual solvents and residual monomers, release rate and physical tests in transdermal formulations. • Perform method validation, appropriate to phase of project.• Lead transfer of analytical methods to QC laboratory at manufacturing site.• Implement partner-developed methods within St. Paul DDSD.• Provide direction to 3M and contract personnel on the Analytical team.• Serve on multi-function project teams, and Joint Technical Teams (including partner), including giving presentations of analytical data to partner.• Support in preparation of ANDA submissions. • Leadership in preparation of responses to Complete Response Letters (CRL) from FDA.• Recognized with Circle of Technical Excellence and Innovation Individual award, Division level, 2014.• Recognized with Circle of Technical Excellence and Innovation Team award, Business Group level, 2018.

3M Center, St. Paul Mn

Lead Analyst on internally-developed pharmaceutical programs.Highlights:• Analysis of formulations to support clinical and toxicology studies, developmental and registration stability, and formulation development.• Analytical method development, validation and implementation.• Testing of raw materials for Pharmaceutics formulation development, and reference standards for Analytical use.• Provided direct and technical supervision of analysts in the clearance of toxicology and clinical supplies, and in analysis of stability and formulation development samples. • Participation in development teams.• Served as Lead Analyst on an internal development project. Responsible for leading team to timely completion of all analytical tasks in support of clinical programs. Represent department on multi-functional project teams.• Served two years as Marketed Product Support Lead Analyst; served as technical resource for global Marketed Product Support Teams. Extensive interaction within multi-disciplinary teams, manufacturing sites and partner companies.• Review and approval of raw material and finished product specifications.• Review of the compendia for changes to product specifications and methods. Implementation of compendial changes to methods, work with our Staff Quality Assurance organization to implement specification changes.

3M Cottage Grove,Cottage Grove Mn

Duties included performance of routine and non-routine testing of in-process and final samples, incoming raw materials, instrument calibration, reagent standardization, and special request analyses for product engineers. As Quality Group Leader, I was responsible for overseeing the daily activities of the testing crew over a rotating three-shift operation, prioritizing testing, and interacting with engineering, production and technical groups within the organization. I had direct supervision responsibility for as many as two analysts at a time. Also trained as an ISO Auditor and served on Compliance Audit Team, performing quality audits within the plant.

3M Center, St. Paul Mn

Operate developmental coater to produce magnetic tape products for evaluation. Also served in compounding and dispersion preparation areas.