Expert Aseptic Processing Professional
3 days ago
We are seeking an exceptional Expert Aseptic Processing Professional to join our dynamic team at Ascendis Pharma A/S. As a key member of our operations, you will play a vital role in ensuring the seamless production of commercial drug products while maintaining compliance with current legislation and approvals.
Our ideal candidate possesses a strong background in 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 successful applicant will have a proven track record of working within this domain and demonstrate excellent analytical skills, attention to detail, and problem-solving abilities.
About the Role- Prepare regulatory documentation for submission in new countries, respond to queries from health authorities, and review colleagues' registration documentation.
- Support manufacturing activities at Contract Manufacturing Organizations (CMOs), including follow-up on deviations, changes, production metrics, continued process verification activities, and optimization projects.
- Facilitate inter-departmental communication and ensure effective handoffs to execute critical project milestones.
The successful candidate will be responsible for:
- Coordinating with cross-functional teams to guarantee smooth tech-transfer from development to commercial manufacturing.
- Evaluating and implementing process improvements to optimize quality and efficiency.
- Maintaining a close relationship with CMOs to monitor process performance and address any concerns.
To succeed in this position, you should possess:
- A relevant university degree - ideally a Master of Sciences, Pharmacy, Engineering, or a related field.
- 5-10 years of experience within the field of drug product manufacturing and/or regulatory and QA requirements for drug products destined for market supply.
- Familiarity with aseptic processing techniques and procedures.
- An analytical mindset, with the ability to troubleshoot complex issues.
In addition, you should be proficient in English and Danish at a professional level, both written and spoken, and possess advanced MS Office skills.
This is an exciting opportunity to join a fast-growing biopharmaceutical company committed to making a meaningful difference in patients' lives. If you're passionate about delivering results, possess a strong scientific understanding, and thrive in a collaborative environment, we encourage you to apply for this challenging role.
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