Bioanalytical Manager Large Molecules (f/m/d)

Bioanalytical Manager Large Molecules (f/m/d) – clinical studies /pharma / vendor management / PMP / Agile

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Bioanalytical Manager Large Molecules

Background:

As part of the Pharma Research and Early Development organisation in Basel, the department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinical development. The group of Regulated Bioanalysis acts as an interface for the conduct of bioanalytical development projects in cooperation with external contract research organizations (CROs), various internal pre-clinical and clinical stakeholders and health authorities.

This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This is focused on large molecules.

Ideal Candidate:
The perfect candidate is someone who has done a similar position previously within a pharma (preferred) or a CRO, focusing on large molecules. The manager is also open to an experienced scientist with strong focus on large molecules very keen to learn and with a positive attitude. Please note the preference goes to the first profile. In any case, the successful candidate will have an education within biology / biochemistry.

Tasks & Responsibilities:
* Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs
* Responsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.
* Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.
* Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.
* Participate actively in PS subteams, act as primary contact person for DMPK project leader.
* Act as Bioanalytical Leader when required. Interact proactively with the assay development team.
* Ensure full compliance with the current global and local bioanalytical guidance and GxPs.
* Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.
* Provide technical leadership in issue resolution.
* Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.
* Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.
* Maintain open links with other disciplines within the department and the organization.
* Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues

Must Haves:

Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis (first option preferred)
* Excellent work experience of large molecules bioanalysis in regulated PK, ADA and Biomarkers
* Strong vendor management experience, looking after outsourced studies to external CROs.
* Degree in biology/biochemistry
* Ability to apply the regulations from validation to sample analysis and troubleshoot virtually

Certifications:

Project Management (PMP) – Scrum-Master (SM) – Product-Owner (PO) – Organizational Change management (ProSci)
Agile Experience

Reference Nr.: 922099SGR
Role: Bioanalytical Manager Large Molecules
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.12.2022 (up 3 month notice period welcome)
Duration: 18++

Deadline: 14.11.2022

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.