Director Drug Product Manufacturing

Ascendis Pharma

Hellerup, Hovedstaden
Permanent
Fuldtid

1 måned siden
Nem ansøgning

Work on late stage and commercial projects in a fast-growing biotech companyAs Director in Drug Product Manufacturing, you will head up the drug product manufacturing department responsible for the Life Cycle Management (LCM) of commercial drug product and hence all drug product productions, filings after first commercialization’s and adherence to the validated state. You will be working cross functionally in Ascendis Pharma with a lot of stakeholders at all levels and you will be responsible for people management with-in the department.Furthermore, you will be responsible for ensuring the process for a smooth tech-transfer from Development to Commercial Manufacturing and to establish close and high-standard cooperation with the CMOs used by Ascendis Pharma for commercial aseptically produced Drug Products.The position reports to the VP of Drug Product & Device Manufacturing and the candidate will be part of a highly dedicated and experienced team.The main responsibilities are:

Daily people management and coordination/prioritization of tasks
Secure inter-departmental communication and ensure effective handoffs to execute on important milestones
Development of LCM strategies in collaboration with colleagues in Product Supply & Quality (PSQ)
Ensure that projects/tasks are conducted optimally with respect to quality, timeliness and budget
Ensure that direct reports thrive and are developed to maintain a high scientific level in drug product manufacturing
Involved in writing regulatory documentation for BLA/NDA/MAA and main responsible for filing in all other markets for drug product
Involved in scientific documentation review and drafting
As daily point of contact responsible for coordination of activities between Ascendis Pharma and CMO during transfer to commercial and in the commercial phase

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 field and preferable with a track record of hands-on aseptic processing and documentation.The following qualifications are appreciated:

A minimum of 5 years leadership experience
A minimum of 10 years of experience within the field of drug product manufacturing from the pharmaceutical industry
Experience within aseptic processing
Experience with pre-launch and post PPQ activities such as upscaling/tech transfer/optimization of manufacturing processes
Experience with late-stage development and production
An analytical mindset and ability to troubleshoot complex issues
Experience within regulatory and QA requirements (EMEA and FDA regulations) for drug product to be manufactured for market supply
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 an energetic, outreaching and a pragmatic person with an open and communicative approach, and you work effectively with employees at all levels, and you enjoy being in a position with an international reach. You are flexible, persistent, and resourceful. You are analytical and science-driven, and you identify and resolve problems in a timely manner. You are a flexible, adaptable, and robust person with a hands-on attitude. You are a person who has a personal commitment to delivering results in a changing environment.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: 15 - 20 days per year.Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.For more details about the job or the company, please contact Senior Director Thomas Bjerg on M +45 93 60 62 64 orApplications will be evaluated when received, so please apply as soon as possible. All applications must be in English and are treated confidentially.

Ascendis Pharma