Cross Functional CMC/Safety Toxicologist
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Master's Degree
Total Vacancies
1 Job
Posted on
Feb 24, 2021
Last Date
Mar 24, 2021
Location(s)

Job Description

Join a leading and fast-growing biotech company

Ascendis Pharma a visionary and ambitious company offers you the opportunity to be part of our journey towards becoming a leading rare disease company. Join a fast-growing biotech company in an exciting position.

As our new Cross Functional Specialist you will be a central part in supportive toxicological/safety evaluation work of all Ascendis Pharma’s development projects. You will work independently but in close collaboration with the non-clinical safety, CMC and clinical teams as well as with external partners at the CROs, CMOs and consultants.

You will be responsible for delivering timely and high-quality evaluations of CMC related quality attributes to ensure patient safety and support regulatory interactions, clinical trials and product registration. You will join the Non-Clinical Safety Team in the Non-Clinical Development amp; Bioanalysis Department with highly experienced scientists and report directly to the Director of Non-Clinical Safety. Ascendis Pharma is located in Denmark, Germany and California and you will be in regular contact with employees at all three geographic locations.

Main areas of responsibility:

  • Point of contact for CMC regarding cross-functional collaboration between non-clinical safety and CMC
  • Define processes for the collaboration between CMC and Non-Clinical Development
  • Safety evaluation of excipients, extractables and leachables and endotoxin thresholds
  • Calculation and documentation of PDE and OEL values
  • Safety input to cQAs and SDSs of our development products
  • Non-clinical justification of DP and DS specification limits
  • Sponsor’s monitor for QSAR assessment reports
  • Deliver input regarding non-clinical evaluation of impurities in INDs/CTAs and contribute to other regulatory documents
  • Set-up and maintain collaborative relationship with internal experts and at CROs and CMOs
  • Participation in quality related inspections from regulatory authorities

You hold a relevant university degree; preferably a MSc in Biology, Chemistry, Biotechnology, Veterinary Medicine or other Life Science area. Additionally, you have at least 5 years of experience in all or most of the main areas of responsibility, preferable from the pharmaceutical industry or a CMO. Knowledge of quality management systems and GMP is a major advantage. As all our documentation is written in English you need to be highly proficient in spoken and written English.

You are a highly pro-active, enthusiastic and goal-oriented individual with a strong scientific background enjoying challenges and working in a friendly collaborative and quickly developing environment. As you will be working on several tasks in different projects in parallel you work in a structured way, have a high quality-oriented mindset with the right level of details, still keeping the overall picture in mind. Strong interpersonal skills are necessary as you will be a major contributor and trusted member of the department. The ability to understand your customers’ need and 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.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup in Denmark with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Director of Non-Clinical Safety Kristin Abel on +45 24 44 85 30 or .

Please submit your application as soon as possible as we will interview on an ongoing basis. This position will be closed once the right candidate has been found. All applications must be submitted in English and will be treated confidentially.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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