Tage Carlson Phd, Dabt Email & Phone Number

Libertyville, Illinois

Round Lake, Illinois

Oversaw global organization responsible for toxicologic evaluation and risk assessment of all medical devices, biomaterials, drug formulations and packaging systems. Supported all nonclinical safety aspects of product lifecycle including nonclinical plan development and testing oversight, material biocompatibility strategy, safety assessment of material-derived leachables and chemical hazard assessments. Accountable for technical capability and quality, ensuring cross-functional alignment and adequate representation on product development teams. Oversaw regulatory toxicology strategy and risk communication to senior management and health authorities. Led organizational strategy and development of staff, department’s performance and continuous improvement.Skills: Organizational Leadership, Global Management, Risk Assessment, Coaching, Talent Developer, Cross-cultural Communication Skills, Cross Functional Relationships, Scientific Management, ISO 10993, Medical Devices, Toxicology, Life Sciences, CRO, Biocompatibility, Regulatory Submissions

Round Lake, Il

Managed Regulatory Toxicology, General Toxicology and Material Testing groups responsible for overall strategy and execution of biocompatibility testing according to ISO 10993 and USP standards. Teams consisted of 30 BS and MS-level colleagues including 4 first-line managers.Skills: Medical Devices, Toxicology, GLP, Biocompatibility, Regulatory Submissions, Organizational Leadership, Risk Assessment, Coaching, Talent Developer, ISO 10993, Cross Functional Relationships, Regulatory Requirements, Change Control, Scientific Presentation, Scientific Management

Abbott Park, Il

Core member of drug development teams, with emphasis on anti-viral and CNS disorder therapies, working across divisions to coordinate and execute preclinical safety plan supporting all phases of drug development. Directed exploratory and GLP toxicology studies across all therapeutic areas, monitored toxicology studies conducted externally, conducted due diligence to support partnering initiatives, conducted impurity risk assessments and streamlining internal toxicology operations.

Lafayette, Nj

Core member of drug development teams, working across divisions to coordinate and execute preclinical safety plan. Member of early development teams supporting anti-cancer and anti-viral therapies and late-stage development teams supporting sublingual immunotherapies (SLIT) and anti-inflammatory drugs. Oversaw development of compounds derived both in-house and through strategic partnerships. Served as Drug Safety’s representative to Hepatitis C Virus Proof-of-Concept Team and defined key safety and efficacy measures to improve clinical success and expedite proof-of-concept testing

Responsible for management and all aspects of the Drug Safety Clinical Pathology laboratory. CAP-accredited and GLP-compliant laboratory consisting of 16 full-time scientists and technicians including one first-line manager. Responsible for hematology, clinical chemistry, urinalysis and coagulation support of all preclinical discovery, preclinical safety, and Phase I clinical testing at the Ann Arbor facility with an average yearly volume of 300,000 tests.

Responsible for the management of the clinical chemistry section within Drug Safety’s clinical pathology laboratory and the career management of 7 full-time direct reports. Responsible for novel assay development, assay translation from animals to man, new technology validation, and quality control measures. Additional responsibilities included expanded roles in clinical pathology data review, managing the clinical pathology peer-review process and directing GLP safety studies.

Responsible for managing one direct report and the development of novel molecular assays in support of preclinical safety studies. Methodologies included RT-PCR, quantitative PCR, traditional cloning methods, DNA sequencing and Western blotting. Additional responsibilities included summary of clinical pathology data and directing preclinical safety studies for inclusion in FDA submissions.

Phd, Molecular Biology

Thesis Title: Mechanisms of HSF Activity Regulation in Saccharomyces cerevisiae.

B.S., Biology