Lab Leader Regulated Large Molecules Bioanalytics - PHARMA / ro-489

Status: 
closed
Location: 
4070 Basel
Start Date: 
2018-08-01
End Date: 
2019-07-31
Deadline: 
2018-08-03 11:30
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
2.088
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) an Lab Leader Regulated Large Molecules Bioanalytics - PHARMA

•    Type of placement: 12 months, external contract with possible long term extension
•    Company:  major Pharma company in Basel area
•    Salary:  level 1, please ask us for the exact rate range 
(monthly gross salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k) 

 

Description

Job Profile Lab Leader Regulated Large Molecules Bioanalytics (Temp Position 1 Year)

 

Responsibilities

  • Supervise and be responsible for a bioanalytical laboratory doing Large Molecule Regulated Bioanalysis
  • Guide the technical personnel skill development
  • Collaborate closely with the assay development team to design highly sensitive and specific methods for the quantification of therapeutic proteins, the detection of anti-drug antibodies and their characterization in biological material for development and marketing which satisfy the project needs and fulfill regulatory requirements
  • Validate and apply such bioanalytical methods to the analysis of biological samples generated from toxicity studies and clinical studies according to the principles of GLP and GCP
  • Transfer bioanalytical methods to other laboratories (CRO), when necessary
  • Report methods and results in appropriate form and contribute to integrated summary documents
  • Maintain scientific and technical knowledge in the state-of-the-art methodologies for therapeutic protein quantification, anti-drug antibody detection and characterization by particular ligand binding assays and cell-based assays
  • Keep awareness in the operation and application of required laboratory equipment
  • Take responsibility of adherence to GLP/GCP in his/her area
  • Play an active role in the organization of information and expertise sharing, prompt communication and contribution to project coordination
Requirements: 

Must haves for this role

At least Master in Biology, Biochemstry, Chemistry or equivalent, hands on experience with ligand binding assays, GxP experience, first industry experience as lab head, experience in clooaboration with CROs wou

 

Required Training and Qualification

  • University education in Chemistry, Biochemistry, Biology, Pharmacy with master degree, doctoral degree is an additional asset
  • Experience with leading a laboratory in Regulated BA Large Molecules, in a GxP environment
  • Training in state-of-the-art analytical techniques with proven ability for independent work with special emphasis to ELISAs, cell culture, cell based assays and other molecular based techniques to quantify, qualify and characterize therapeutic proteins and anti-drug antibodies, with computerized data acquisition and with sample preparation techniques
  • Basic GLP/GCP Training and recurring refresher courses
  • Good knowledge in English, both written and spoken