What are the responsibilities and job description for the Sr. Manager, Bioanalytical position at Rigel Pharmaceutical?
POSITION SUMMARY:
The position reports directly to the Executive Director, Clinical Pharmacology, and is responsible for outsourcing, managing, and quality assured the bioanalytical sample analysis, in support of all the clinical pharmacokinetic and GLP toxicokinetic studies required for the drug development programs at Rigel. The position is also responsible for assuring GLP-bioanalytical compliance of the deliverables to meet regulatory quality requirements. Salary range $127,194 $149,640.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
(may vary according to the area of expertise and assignment focus of the individual)
- Collaborate with external Rigel partners conducting clinical studies with Rigel products, assisting with all aspects of PK sample handling and bioanalysis, including sample collection procedures, shipment, choice of CRO, and data analysis and presentation,
- Ensure availability of necessary material and documentations for bioanalysis of Rigels product, including GLP grade drug substance and derivatives, and up to date C of A for various substances,
- Collaborate and coordinate with internal Rigel colleagues to ensure timely delivery of bioanalytical samples to designated CROs,
- Oversee development of bioanalytical assays at CROs
- Act as bioanalytical PK data manager, including development of data transfer agreement (DTA) documents
- Calculate PK parameters
- Prepare bioanalytical reports and presentations that meet GxP requirement
- Maintain data base for generated information
- Evaluate and summarize data in a critical manner for dissemination to project leaders
ADDITIONAL RESPONSIBILITIES:
- Preparing various PK results, including graphs, for presentations
- Presentation of data in group meetings or project team meetings
- Interacting with other members of the group to discuss data
KNOWLEDGE AND SKILL REQUIREMENTS:
- BS and 10 years of industry experience or an MS and 4-6 years of industry experience in biology, immunology, or a related field
- Deep knowledge base in instrumental bioanalysis, pharmacokinetics and drug metabolism
- Excellent communication, organization, and presentation skills are necessary
- Ability to conduct research both independently and in a team setting in a fast-paced environment
WORKING CONDITIONS:
- PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- WORK ENVIRONMENT: The noise level in the work environment is usually moderate. There may be some potential exposure to hazardous materials. Some travel may be required.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
Salary : $127,194 - $149,640
