Project Manager Bioanalyses
Affibody is looking to recruit a project manager for bioanalyses in pre-clinical and clinical development. The position will be part of the group Translational Medicine, TM, and the location is at our newly established premises in Solna.
The project manager will be part of several project teams and responsible for coordinating bioanalyses for plasma drug exposure, anti-drug antibodies (ADA), neutralizing ADA, and biomarkers in pre-clinical and clinical studies. The project manager will be the point of contact for the contract research organizations (CROs) conducting the analyses and be the interface between different stakeholders to ensure timely planning of bioanalyses.
The project manager will be involved from the early stage planning of pre-clinical and clinical studies, being responsible for planning and outsourcing of bioanalyses and coordinating analyses, throughout the conduct to study closure, in close cooperation with subject matter experts (SMEs) and the project teams. The project manager will also have an important role in planning and keeping oversight that assays are developed and validated in time and to ensure applicable quality requirements are fulfilled. In addition, the project manager will have responsibility for ensuring availability and stability of critical non-commercial reagents, compliance with regulatory requirements as well as supervision of the long-term assay development and validation strategy (together with SMEs).
The role is characterized by strong skills in communication, planning and logistics as well as an interest in, and some hands-on experience of, bioanalytical assays, e.g. ELISA and MSD based methods for detecting ADA and LC/MS/MS methodology for serum/tissue exposure analyses.
The role in general
As project manager for bioanalyses the responsibilities and activities include:
- Effective communication with project teams and CROs and coordination of sample bioanalyses (plasma drug exposure, ADA, neutralizing ADA, and biomarkers) in pre-clinical and clinical studies, from planning stage to study closure
- Responsible for outsourcing activities for bioanalyses in pre-clinical and clinical studies in close interaction with Outsourcing & Contracts Management, including supervision of performance, timely provision of deliverables and check of invoices for contracted services
- Contact person for CROs conducting the analyses and responsible for in-time availability of concerned bioanalyses plans
- Oversight of overall assay strategy during the pre-clinical and clinical development, assuring timely development and validation of assays in close collaboration with SMEs
- Facilitate contact between CROs and SMEs regarding development, technology transfer, and validation of assays, and transfer of non-commercial reagents
- Tracking availability and stability of critical non-commercial reagents, the issuance of data sheets or certificates of analysis for critical non-commercial reagents
- Staying up-to-date with quality and regulatory requirements for the development of assays, analyses and reagents
- Keeping overall control of bioanalyses and maintaining interdisciplinary communication with different functions/SMEs, both within the company and with external CROs or consultants
The right candidate fulfills the following qualifications:
- University degree in e.g. Chemistry/Biology, Molecular Biology or Biotechnology, and a minimum of 5 years of experience in the pharmaceutical industry
- Experience of cross functional team work and analyses within preclinical and/or clinical studies
- Understanding/experience from method development and validation
- Experience from outsourcing analytical methods
- Knowledge in quality and regulatory requirements
- Strong communication/interpersonal skills
- Organizational skills
- Advanced knowledge of Excel and/or other tracking tools
- Excellent verbal and written communication skills in English and ability to communicate in a business environment
To be successful in the role you need to be highly self-motivated and self-driven. You need to have the ability to collaborate, demonstrating strong team working skills, to establish and maintain good collaboration with different parties, both externally and internally. You have capabilities to coordinate and make long-term plans, to follow through and to handle/mitigate deviations as they occur. You provide sound solutions to problems and identify with whom to communicate and interact. The role requires both operational management and strategic oversight. You have the ability to work independently and to make priorities in order to deliver business critical items in time.
We will interview candidates continuously and welcome your application today!
Please send your application (CV and a note on why you think this is your next step) to firstname.lastname@example.org. If you have any questions about the role, please contact VP Head of Translational Medicine, Marie Österlund, at email@example.com.
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Affibody in short
Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
Upcoming reports Financial calendar
- Interim Report January to March 2020 (May 15, 2020)
- Interim Report January to June 2020 (August 21, 2020)
- Interim Report January to September 2020 (November 13, 2020)
- Year End Report 2020 (February 2021)