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Cross Functional CMC/Safety Toxicologist

Ascendis Pharma A/S is an international company with offices in Copenhagen, Germany, and the US. Ascendis Pharma is building an integrated biopharmaceutical company to advance its pipeline of long–acting prodrug therapies.

They employ their proprietary “TransCon” technology platform to generate therapeutics with best-in-class profiles that address large markets with significant unmet medical needs. Ascendis Pharma has a diversified and balanced high-value product pipeline, including internal programs and partnerships with market leaders.

The Department

You will join the Non-Clinical Safety Team in the Non-Clinical Development & Bioanalysis Department with highly experienced scientists and report directly to the Senior Director of Non-Clinical Safety. You will be part of a team that consists of 5 highly skilled colleagues being responsible for several different projects. Your role will be to work cross functional focused on the cooperation with CMC. Ascendis Pharma is in Denmark, Germany and California and you will be in regular contact with employees at all three geographic locations.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a nice view of the harbor, the canals, and the sea. Read more at www.ascendispharma.com.

Cross Functional CMC/Safety Toxicologist

Highly proactive, enthusiastic and goal oriented

– Central role in supportive toxicological/safety evaluation work
– Part of a journey towards becoming a leading rare disease company
– You will both work independently and in close collaboration with the team
– Potential to grow your professional and personal skills

The Challenge

On behalf of our client Ascendis Pharma, Best Talent is now looking for a Cross Functional CMC/Safety Toxicologist. You will be a central part in supportive toxicological/safety evaluation work of all Ascendis Pharma’s development projects.

You will work independently but also 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.

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 their 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, CROs and CMOs
– Participation in quality related inspections from regulatory authorities

Talent

You hold a relevant university degree, preferably a MSc in Biology, Chemistry,

Biotechnology, Veterinary Medicine, or other Life Science areas. 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.

As a person you are a highly pro-active, enthusiastic, and goal oriented individual. You have a strong scientific background, enjoy a challenge, working in a friendly collaborative and quickly growing 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 detail, keeping the overall picture in mind.

Strong interpersonal skills are necessary in this position 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 are 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.

Application

Best Talent is responsible for the recruitment proces and will be handling your application on a confidential basis. Forward your application marked ”1729/Toxicologist” to job@besttalent.dk. Read more about Best Talent on www.besttalent.dk and more about Ascendis Pharma on www.ascendispharma.com