Ascelia Pharma is an oncology-dedicated drug development company located in Malmö, Sweden, focused on the development of novel drugs to improve the life expectancy and quality of life for people living with cancer. Ascelia´s strategy is to develop and make available to patients a portfolio of differentiated, underappreciated and de-risked product candidates addressing unmet medical needs in cancer and cancer-related diseases. Ascelia is fully focused on two clinical-stage product candidates under development: Mangoral and Oncoral. The IPO on Nasdaq Stockholm has secured financing for the full Phase III program for Mangoral.

Mangoral
Our lead candidate Mangoral is a liver imaging drug (i.e. a liver specific contrast agent) being developed for detection and localization of potential liver metastases, using Magnetic Resonance Imaging (“MRI”) in patients where use of the current gold standard gadolinium-based contrast agents (“GBCAs”) may be medically inadvisable. Mangoral is the only product targeting this market opportunity of $350-500 million annually and the Phase III study will be initiated in 2H 2019. Mangoral has Orphan Drug Designation from the FDA.

Oncoral
Our second drug candidate Oncoral is a novel tablet-based formulation of the well-known chemotherapeutic agent irinotecan, intended for the treatment of advanced gastric (stomach) cancer. Oncoral has completed Phase I studies with encouraging results and preparations for Phase II are ongoing.

Ascelia’s mission - to improve the quality of life expectancy of people living with cancer and cancer-related conditions.

Ascelia’s vision - to make available differentiated orphan medicinal products in oncology that satisfies an unmet medical need.

The company was founded in 2000, is recently listed on Nasdaq Stockholm, Small Cap, March 2019, based in Malmö, and employs 6 people today.

For more information about Ascelia Pharma, please see http://www.ascelia.com

 

TILLSATT - Director of CMC


As the Director of CMC, you will be responsible for all CMC-related activities, including development and manufacturing of drug substance (API) and drug product (DP), to support preclinical and clinical development as well as commercial manufacturing. Manufacturing is outsourced to CDMO’s.

The candidate must have an excellent understanding of the drug development process, experience in managing external vendors including CDMOs and
ability to operate effectively within a pharmaceutical start-up setting. You will be responsible for all strategic and operational aspects of manufacturing of investigational medicinal products as well as commercial products in Ascelia Pharma’s project portfolio. The candidate will provide leadership, project management and program oversight to ensure timely supply of high-quality small molecule medicinal products in accordance with GMP regulations to support clinical development, regulatory authority submissions and commercial sales globally.

The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities. As the company is small, you must have a “can do” attitude and be comfortable in situations where you are hands-on. Integrity and an independent character is highly valued, and should be combined with the ability to effectively coordinate and inspire team efforts towards meeting stretched goals. The Director of CMC will report to the Chief Executive Officer.

Responsibilities including but not limited to
Responsible and accountable for the conduct of CMC operations
Identify, select and manage Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of API and DP to support ongoing clinical programs
Deliver robust, scalable and cost-effective manufacturing routes for API manufacturing
Prepare, review or edit cGMP, regulatory and Quality CMC documents. Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA/EMA regulations. Writing and reviewing documents for INDs / regulatory section submissions
Anticipate and project API and DP needs for preclinical and clinical programs and associated budgets, in collaboration with Ascelia Pharma’s Management Team; manage supply chain and logistics to support clinical studies
Prepare and ensure commercial product supply for launch of Mangoral in 1H 2022, including responsibility for CMC parts of NDA/MAA submissions
Work collaboratively with cross functional internal and external teams including regulatory affairs
Identify, qualify, audit, and manage all external vendors, including CDMOs and CROs. Take initiative to continually monitor each external vendor in performance management
Identify any gaps in company/CDMO SOPs and develop internal SOPs as needed

Requested qualifications
• PhD or MSc in Medicinal Chemistry, Organic Chemistry, Analytical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• Many years of experience in a pharmaceutical or biotechnology CMC/cGMP environment and experience in small molecule manufacturing
• Solid CMC experience of all phases of small molecule drug development
• Knowledge of CMC requirements for regulatory filings covering all phases of pre-clinical and clinical development in both the US and key ex-US markets
• Experience with IND, CTA and NDA/MAA filings; thorough knowledge of relevant FDA and EMA regulations
• Experience with Life Cycle Management and IPR would be an advantage
• Demonstrated ability to negotiate and manage international CROs and CDMOs for the manufacture of cGMP APIs and DPs. Experience in supply chain management would be a plus
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook)
• Fluent in oral and written English
• All necessary permits to work in Sweden

Desired Skills/Experience
• Proactive, forward-thinking and a team player with leadership skills to achieve successful outcomes in collaboration with internal team and external collaborators, within budget and in a timely manner
• Demonstrate project management capabilities such as prioritize tasks and resources, meet deadlines, manage multiple priorities, while maintaining attention to detail is critical and be flexible to changing priorities
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
• Ability to analyse data and make rational judgements from available information and analysis
• Demonstrate technical capabilities and ability to rapidly learn new tasks, gather comprehensive information to support decision making and share knowledge and insights of use to the organisation
• Strong ethical values with high integrity

Opportunities with the role

This is an opportunity to work in a rapidly growing biotech company listed on Nasdaq Stockholm, with short decision-making processes where each employee's contribution is important for the company's development and results. You will have the full responsibility for the manufacturing of APIs and DPs and be part of the process all the way from clinical phase to the products reaching a global market.

Contact
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Sr Recruitment Consultants at PeakSearch.

catharina.herbertsson@peaksearch.se, +46 (0)706 152 772
eva.runnerstrom@peaksearch.se, +46 (0)701 725 379
http://www.peaksearch.se

Application
Apply for the position at PeakSearch homepage
http://www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, see above.