Scientist in Translational Science

at  Hansa Biopharma

WOULD YOU LIKE TO BE PART OF A GROWING BIOPHARMA COMPANY?

Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with rare immunological conditions.
Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.
By empowering our people and working in an agile way we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.
Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.
Position: Scientist to the Translational Science department
We are seeking an experienced and highly motivated Scientist based at Hansa Biopharma HQ in Lund. You enjoy working with Bioanalysis activities and have wide experience working with biological products. In this role you will take part in the development of immunoassays and cell-based assays, as well as analysis of pre-clinical, clinical samples. Experience of Gene therapy is advantageous.
We are a team with 13 highly skilled members and are looking for a colleague that is broad and flexible in working cross functionally and can manage questions that may not always be within your immediate work field.
In this position you will report to the Senior Director of Translational Science at Hansa Biopharma.

PROFESSIONAL QUALIFICATIONS

In order to succeed in the position, we believe that you possess:

• A PhD in Bioanalysis/Biochemistry or Medicine in a relevant field
• At least 3 years of experience from the industry working with biological products
• Knowledge in GCP, GcLP and GLP quality system for the pharmaceutical industry
• Experience of immuno assay development for PK/PD and ADA/Nab determination
• Experience of MSD technology

• Experience of cell culturing and cell-based assaysFluency in written and oral English

Additional qualifications are desirable but not a requirement

• Experience of FACS
• Experience of gene therapy

PRINCIPAL RESPONSIBILITIES

The Translational Science department is focused on development of PK/PD/ADA/Nab immuno- and cell-based assays, toxicological development, analysis of pre-clinical and clinical samples, Pharmacokinetic evaluations, monitoring analytical work outsourced to CRO/CMO, support in early research and development, regulatory discussions and part of project groups.

Main tasks in the position are:

• Develop immunoassays and cell-based assays
• Plan and perform immunogenicity assessment experiments
• Analyze pre-clinical (non-GLP) and clinical study samples according to current regulatory guidelines and company procedures
• Outline and review analytical and validation plans and reports
• Develop and transfer analytical methods to CRO/CMO

• Archiving of bioanalytical raw dataOutline and review Quality Documents e.g. Analytical Method Descriptions, SOPs and policies

As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

• Comfortable in taking responsibility and enjoy taking initiative
• Ability to drive collaboration with vendors, and external and internal parties
• Creative mind with ability in solution-oriented analytical thinking
• Thriving in fast moving project environment, enjoy challenging tasks with tight deadlines
• Comfortable in small company setup and work outside your expertise area when neede