Drug Product Specialist

Job title:

Drug Product Specialist

Company:

Ascendis Pharma

Job description

Job Description:Are you passionate about making a difference for patients with unmet medical needs? Do you have experience within drug product manufacture and/or registration? If so, now is your chance to join Ascendis Pharma as our new Drug Product Specialist.Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, Spain, Italy and the United States.We are applying our TransCon® technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfil our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.As Drug Product Specialist at Ascendis Pharma your primary tasks are to ensure that our commercial drug products are produced in accordance with current legislation and approvals and to support our submissions to health authorities worldwide. You will take part in ensuring a smooth tech-transfer from development to commercial manufacturing, establishing a close cooperation with our contract manufacturing organizations and tracking process performance.The position reports to the Director of Drug Product Manufacturing and the candidate will be a part of a highly dedicated and experienced team located in Hellerup.The main responsibilities are:

• Prepare regulatory documentation for submission in new countries, answer questions from health authorities and review colleagues´ registration documentation
• Supporting manufacturing activities at the CMOs including follow up on deviations, changes, production metrics, continued process verification activities and optimization projects
• Support inter-departmental communication and ensure effective handoffs to execute on important project milestones

You hold a relevant university degree – preferably a Master of Sciences, Pharmacy, Engineering, or the like.The successful applicant will have a proven record of working within the aseptic processing preferably within the drug product field and/or a background in authority registration of medicinal products with a good insight into aseptic drug product manufacture. The following qualifications are appreciated:

• 5 – 10 years of experience within the field of drug product manufacturing and/or regulatory and QA requirements for drug product to be manufactured for market supply
• Experience within aseptic processing
• An analytical mindset and ability to troubleshoot complex issues
• Ability to manage details and at the same time ensure a holistic approach towards all steps in the manufacturing process including analyses and regulatory impact

You are proficient in English and Danish at a professional level, both written and spoken, and you master MS Office.You are a personwho has apersonal commitment to delivering results. You are analytical and science-driven, and you identify and resolve problems in a timely manner. You are a flexible, adaptable person with a hands-on attitude. You are pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You can handle and deliver on routine jobs, while at the same time having the ability to move projects forward.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 together with highly skilled and experienced colleagues to further advance our exciting product pipeline.Travelling: 10 – 15 days per year.Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup near the harbour, the canals, and the sea.For more details about the job or the company, please contact Senior Director Karen-Margrethe Eegholm on +45 42 66 82 41 or kem@ascendispharma.com.Applications will be evaluated when received, so please apply as soon as possible. All applications must be in English and are treated confidentially.

Expected salary

Location

Hellerup, Hovedstaden

Job date

Fri, 22 Nov 2024 08:52:10 GMT

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