QC Specialist with Project Manager skills, Ascendis Pharma / 1747
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.
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.
QC Specialist with Project Manager skills
Join the Product Supply Team in a leading and fast-growing biotech company
- Introduction of new products to be marketed
- Secure successful cooperation with CMO´s and colleagues
- Potential to grow your professional and personal skills
The QC Carrier, Linker team is one of four teams in the Drug Substance Manufacturing (DSM) department. The team consist of 5 persons, which is expected to grow as more products are moved to the commercial part of the organization.
You will as QC specialist be responsible for keeping QC oversight of starting materials and intermediates produced and analysed at CMOs. You will be reporting to the Director, QC Linker Carrier and join a team of highly experienced and social colleagues working together to obtain the best results in a timely manner.
Criteria of success in this role is efficient and timely coordination of analytical activities for the commercial manufacturing of starting materials and intermediates for TransCon Growth Hormone
Manufacturing and TransCon parathyroid Hormone. You are expected actively to contribute with your analytical knowledge to further build up Ascendis QC-Linker Carrier capabilities and to take
ownership for establishing and maintaining a successful and smooth collaboration with Ascendis colleagues and the CMOs.
Your main responsibilites are:
- Coordination and keeping oversight of analytical activities between Ascendis and CMOs being one point of contact in analytical matters
- Facilitate and support analytical performance and efficiency improvements at CMO’s
- Keep up-to-date with scientific and regulatory development in areas of analytical testing, analytical methods and analytical validation
- Coordination of or participation in internal project related activities
- Ensure a smooth tech-transfer from Development to Commercial Manufacturing and betweeen different CMO’s
- Review and approval of analytical validation activities performed by the CMOs
- Scientific and GMP-compliance review of analytical deviations and changes
- Establish procedures for internal review and handling of analytical data for commercial manufacturing
- Writing of regulatory documentation and follow-up on post-approval commitments to autorities
- Contribute to the analytical part in establishment of continous process verification programs to the annual product review process
Ideally, you hold a Master of Science degree in Chemistry, Engineering, Pharmacy, or the like. You have several years of practical analytical experience from the pharmaceutical industry. It will be an advantage with experience from a GMP environment and organic chemistry, especially NMR analyses but also GC, GC/MS, LC-MS, NMR, HPLC/UPLC. Experience with support to chemical manufacturing either from an Analytical Development Laboratory or from a QC support laboratory would be beneficial.
Experience with tech transfer from development to commercial manufacturing and tech transfer between different CMOs as well as experience with QC performance tracking tools is an advantage.
You are proficient in English at a professional level, both written and spoken, and you master MS Office.
Your background should help you to guide project teams at CMOs through conceptual as well as specific practical discussions.
As a person you have a high level of drive, ambition, and passion. You have a risk based, structured and systematic approach to solving tasks. In your job you will have many stakeholders internally and externally and you thrive with being in contact with new people and cultures. You enjoy being challenged and working in a collaborative environment. You possess a high energy level and can focus on details when needed. You have excellent abilities to keeping overview even with many active tasks at the same time.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company. We have a dynamic, innovative, informal, and supporting working environment. We work closely across teams and areas within each project and have a short line of command. This is an opportunity to be involved in the exiting journey of Ascendis Pharma to become a pharmaceutical company with commercial production. You will work together with highly skilled and experienced colleagues.
Travelling: 10-20 days per year.
Best Talent is responsible for the recruitment proces and will be handling your application on a confidential basis. Forward your application marked ”1747/QC Specialist” to firstname.lastname@example.org. Read more about Ascendis Pharma on www.ascendispharma.com. We will interview candidates for this position ongoing, but please apply as soon as possible. You can read more about Best Talent at www.besttalent.dk.