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Senior Scientist CMC Analytical Development (Biologics) Job in Denmark
Ascendis Pharma , Denmark

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Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
No
Career Level
Telecommute
No
Qualification
Master's Degree
Total Vacancies
1 Job
Posted on
Mar 16, 2021
Last Date
Jun 16, 2021
Location(s)

Job Description

Ascendis Pharma A/S a visionary and ambitious company, offers you the opportunity to become involved in the development of best-in-class therapeutics for rare diseases addressing unmet medical needs and making a meaningful difference in patients’ lives.

Ascendis Pharma is expanding its CMC resources to support biological assay development and subsequent validations at our Contract Laboratory Organizations (CLOs). We are looking to hire a passionate Senior Scientist with late stage analytical experience to provide effective analytical support for our cell-based bioassays and ELISA-/immuno-assays.

As Senior Scientist in Analytical Development (Biologics) at Ascendis Pharma you will be responsible for outsourcing of cell based bioassays (for potency evaluation) and ELISA-/immuno-assays (for HCP and other potential residuals) with regard to final optimization and validation for Intermediates, Drug Substance, and Drug Product in our development projects (biologics and peptide projects). You will be planning, coordinating and supporting activities at the analytical labs in collaboration with your colleagues and the project responsible person at our contract labs. Your day-to-day responsibilities will vary ranging from detailed analytical discussions, raw data review to overall planning ensuring phase-appropriate analytical control strategy. You will join the CMC Analytical Development (Biologics) team currently consisting of 5 highly experienced CMC analytical experts/project managers.

Your main tasks are:

  • Project management/coordination of analytical activities between CLOs and Ascendis Pharma as daily point of contact
  • Implement/develop and validate product-specific potency assays as well as ELISA/immuno-assays to be established for release and stability testing of our intermediates, drug substances and drug products.
  • Participate in the strategy discussions and decision making for establishing cell-based potency assays for routine analysis and for characterization purposes.
  • Support the analytical team at CLOs and at the Ascendis Pharma Heidelberg facility with analytical development and troubleshooting
  • Discuss and monitor execution of the analytical control strategies
  • Write regulatory documentation for analytical methods, validation and data relevant for the potency and ELISA/immunoassays in the CMC part of INDs/IMPDs, and eventually for the registration file
  • Write, review and approve analytical protocols and reports
  • Participate in setting specifications and justifying the acceptance criteria for intermediates, drug substances and drug products in regards to biological assay
  • Contribute to outlining agreements and work orders for analytical tasks with Ascendis Pharma’s legal staff
  • Participate in project meetings with analytical team at the CLOs

You will join the CMC Analytical Development (Biologics) team and be part of the highly experienced and dedicated team consisting of 5 analytical scientists/project managers, who collaborate on day-to-day basis with CMC Chemical Development and Pharmaceutical Development teams. The Analytical Development (Biologics) team has also close relationship with our colleagues in Heidelberg, who support our development activities for the manufacturing processes and analytical methods. You will report directly to the Director, CMC Analytical Development (Biologics).

Success criteria in this role will be to establish reliable and robust bioassay and ELISA-/immuno-assays methods at the CLOs to support clinical supply for our development programs. You will contribute actively within the CMC project teams regarding analytical challenges as well as discuss and implement the control strategy from an analytical point of view. Additionally, you will be an active player in establishing a close and high-standard collaboration with the CLOs that Ascendis Pharma works with and will be a value-adding resource to them.

Your qualifications are: at least 5 years of documented practical experience from the pharmaceutical industry within development of biological assays in GMP environment either from an Analytical Development or a QC laboratory. A hands-on knowledge of other analytical techniques as well as insight into the CMC development process is preferable. Moreover, it would be an advantage if you have previous experience in working with external collaborators such as CMOs/CLOs. Furthermore, you have a large interest in being involved in complex analytical chemistry. You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You hold at least Master’s Degree preferably in Chemistry, Engineering, Pharmacy or similar.

You are a person who thrive in an environment with focus on collaboration and communication. You are highly motivated, work independently and enjoy being professionally challenged. Strong interpersonal skills are necessary, as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff and external collaborators in a fast-paced environment is crucial. You pay attention to the detail simultaneously maintaining focus on the overall picture. Finally, you must have passion and sense of urgency for developing important new medicines for devastating diseases.

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’ exciting product pipeline.

Travelling: 10-15 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 Director CMC Analytical Development (Biologics), Jesper Veng on +45 24675540.

All applications must be in English and are treated confidentially.

Job Specification

Ascendis Pharma

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