Senior Scientist
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

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 and mature their peptide development projects and are now looking to hire a passionate Scientist with an analytical development expertise to provide effective analytical support to Ascendis’ Phase 2 and Phase 3 projects.

As Senior Scientist in Analytical Development (Small Molecules and Synthetic Peptides) at Ascendis Pharma you will be responsible for supporting analytical method development activities at Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs), including method transfer and validation, release analysis, as well as stability testing for Starting Materials, Intermediates, APIs and Drug Products. You will also be resposible for oversseing execution of these activities in the CMOs analytical labs . Furthermore in collaboration with project team colleagues you will participate in defining activities necessary to support the analytical control strategy for Ascendis peptide development projects. Your day-to-day resposibilities will vary ranging from detailed analytical discussions, review of analytical data and documentation to ensuring a phase-appriopriate analytical control strategy.

Your main tasks are:

  • Implement/develop and validate product-specific analytical methods at CMOs/CLOs
  • Support the analytical team at CMOs/CLOs and at the Ascendis Pharma Heidelberg facility with analytical development and troubleshooting
  • Discuss and monitor execution of the analytical control strategies
  • Support planning of stability studies as well as execute stability data trending and evaluation
  • Write regulatory documentation for the CMC part of INDs/IMPDs, and eventually for the registration file
  • Support characterization activities e.g. identification of (new) impurities
  • Write, review and approve analytical protocols and reports
  • Participate in setting specifications and justifying the acceptance criteria for starting materials, intermediates, in-process controls (IPC), drug substances and drug product
  • 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 CMOs/CLOs

You will join the CMC Analytical Development (SMOL amp; Peptides) team and be part of the highly experienced and dedicated team consisting of 8 analytical scientists/project managers, who collaborate on day-to-day basis with Manufacturing Development and Pharmaceutical Development teams. The Analytical Development (SMOL amp; Peptides) 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 (SMOL amp; Peptides).

Success criteria in this role will be to establish reliable and robust analytical methods at the CMOs 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 CMOs/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 chromatographic analyses in GMP enviroment (e.g. HPLC/UHPLC, LC-MS, SEC) for small molecules and/or synthetic peptides, either from an Analytical Development or a QC laboratory. A hands-on knowledge of other analytical techniques well as insight into the CMC development process is preferable. Moreover a previous experience in working with external collaborators such as CMOs/CLOs as will be an advantage.

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 independantly and enjoy being professionally challenged. Strong interpersonal skills are necessary, as you will serve as a major contributor and trusted member of

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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