Bioanalysis Expert; Project Manager, Sr. Project Manager, or Director
Join the Nonclinical Development & Bioanalysis Team in a Leading and Fast Growing Biotech Company
Ascendis Pharma is focused on building a leading rare disease company providing meaningful improvements in patients’ lives by developing best-in-class therapeutics addressing unmet medical needs by applying Ascendis’ TransCon technology platform.
As Bioanalysis Expert (Sr. Bioanalysis Project Manager/Director at Ascendis Pharma) you will work in multidisciplinary international teams with responsibility for the bioanalysis and/or immunogenicity part of one or more projects within Ascendis Pharma’s portfolio. All analytical activities are outsourced and hence, you will be expected to diligently manage the interaction with external partners and CROs.
You will be responsible for the generation and implementation of bioanalytical strategies on early pipeline projects as well as for projects in clinical development. You will join a Nonclincial Development & Bioanalysis team of eight highly skilled scientists (three Bioanalytical/immunogenicity Experts, four Toxicologists, and one Biologist/Pharmacologist). In addition to external partners and CROs, this department has a close collaboration with Ascendis’ research facility in Heidelberg.
Criteria of success will be to provide high quality and timely bioanalysis and/or immunogenicity input to ongoing and future nonclinical studies and clinical trials.
With direct report to Vice President of Nonclincial Development & Bioanalysis.
Your main tasks are:
- Defining and implementing nonclinical and clinical bioanalysis/immuogenicity strategies on one or more projects
- Outsourcing and coordinating analytical activities (GLP/GCP)
- Responsibility for analytical assay validations and sample analysis
- Bioanalytical/immunogenicity support to early projects
- Writing the relevant parts of INDs/CTAs and other regulatory documents
- Setting up and coordinating the biomarker assay strategy on one or more projects
You are a highly proactive, enthusiastic, and goal-oriented individual with a strong boanalytical background. You enjoy challenges, have a quality-oriented mindset, and like working in a friendly, collaborative environment. Strong interpersonal skills are necessary as you will be a major contributor and trusted member of the department and the respective development teams. The ability to communicate data and recommendations in a professional manner is pivotal. You are proficient in English at a professional level, both written and spoken.
You hold a relevant university degree, preferably a M.Sc. in Chemistry, Pharmacy, Biology or the equivalent. The ideal candidate has a minimum of two to several years of experience within a bioanalytical group supporting nonclinical and clinical development projects. Experience in contributing to documents intended for regulatory submissions is an advantage. As the current portfolio covers prodrugs to both peptide and proteins, experience with peptides and/or proteins is an advantage. Basic PK/PD knowledge is expected.
As a person, you are a highly motivated and passionate individual with a strong bioanalytical mindset, who enjoys a fast-paced and inspiring work environment solving complex challenges with competent colleagues. You have a quality-oriented mindset and like working in friendly, collaborative environment. Strong interpersonal skills are necessary as you will serve as a major contributor and trusted member of the department and the respective development teams. The ability to communicate data and recommendations in a professional manner is pivotal.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance Ascendis Pharma’s exciting product pipeline.
Travelling: 10 – 30 days per year
Domicile: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.
For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and are treated confidentially.