The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. 

Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms. 

For the next possible date we are looking for a Bionalytics Unit Head to step into a permanent position.

Bioanalytics Unit Head (f/m/d)

Responsibilities:

• Lead bio-analytics unit within the company’s Preclinical Development department

• Drive conceptualization and execution of the bio-analytical strategy for all preclinical & clinical development programs

• As such drive development of bio-analytical assays (PK, ADA, NAb and biomarker assays) for clinical and non-clinical applications in house or at Contract

Research Organizations (CROs); ensure availability of data as required per development plans

• Ensure transfer of assays to CROs including organization and monitoring of assay development/validation, as well as conduct of bioanalytical studies in

collaboration with CROs

• Ensure regulatory adequacy of bio-analytical program strategies, perform data analysis, drive data-based internal decision making and report results in

regulatory documents (e.g. study reports, IND, IB and BLA/MAA)

• Lead and mentor team members in bio-analytical aspects

• Act as bio-analytical representative in cross-functional global program teams as required

Requirements:

Degree in Life Sciences (PhD) with at least 5 years of industrial experience in development of biologics covering the described areas

• In-depth knowledge in the areas of assays development and validation (Pharmacokinetics, Immunogenicity and Biomarkers) using MSD®, LC-MS/MS and FACS

based assays incl. recent and upcoming development of regulatory guidelines

• Track record of leading conceptualization of bioanalytical program strategies, ideally as line manager

• Track record of excellence in the area of CRO liaison incl. experience in managing bioanalytical studies according to GLP/GCP

• Experience in regulatory agency interactions, e.g. Pre-INDs, INDs or market authorizations

• Demonstrated ability to work independently on multiple projects in parallel

• Strong communication and presentation skills

• Ability to conduct multiple projects delivering agreed milestones adhering to timelines and budget

• Excellent team player

Fluent in oral and written English, additional German language skills would be a plus

Work Conditions:

• The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and friendly team.

• Above average payment

• Company shares in the form of stock options

• Working from the home office

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.