English
Strike Pharma addresses the pressing need for new and improved individualized treatments of solid tumors.
The company has developed a completely new technology which, based on the genetic profile of each patient tumor, attacks the tumor cells and leaves other normal cells in the body alone. The advantage of this is that you get a much more effective treatment while reducing the risk of side effects. The primary focus is on cancer, but the technology itself has the potential to be used across a wide variety of disease indications.
Strike Pharma’s technology platform accomplishes this with a targeted antibody that delivers synthetically produced tumor material into the immune cells that are specialized in activation of tumor-killing T cells. This results in an immune response where cancer cells are attacked in a similar way to vaccination against infectious diseases. Through genetic analysis, the synthetic material can be adapted to each patient, which is central to individualized treatment.
The company develops a novel next generation Antibody-Drug Conjugate (ADC) technology, the ADAC technology. ADACs is short for Adaptable Drug Affinity Conjugates and are built to improve delivery of tailored made synthetic molecules to specific cell types for improved immune modulation. The first drug candidate is within the ADAC platform. Using the ADAC platform, efficient delivery and prolonged half-life of patient tailored peptide therapeutics will ensure that the body becomes the factory, producing billions of T cells that can find and destroy tumor cells regardless of the location in the body.
“Strike Pharma is very well positioned to have a major impact on the current rapid developments in precision medicine and future individualized treatments”, commented Mårten Winge, CEO of Strike Pharma. The goal is for the platform to be able to treat all types of solid cancers. The need for new cancer treatments is huge and Strike Pharma's method has a great potential, as it is more cost-efficient and at least as effective as today's immuno-oncological treatments.
Strike Pharma was founded in 2020, a spin-off from the research carried out for several years within SciLife Lab's drug development platform (DDD). The technology is based on research from Associate Professor Sara Mangsbo at Uppsala University.
For further information about Strike Pharma, please see the company's website
https://strikepharma.com
TILLSATT - CMC Director
Company: Strike Pharma AB
Position: CMC Director
Reporting to: Chief Operating Officer
Place of position: Uppsala, Sweden
Place of residence: Uppsala/Stockholm
PeakSearch söker på uppdrag av Strike Pharma en erfaren CMC Director. En möjlighet att vara med och utveckla ett litet nystartat biotech bolag!
The role as CMC Director
The CMC Director will facilitate product development by leading the planning and execution of the chemistry, manufacturing, and control (CMC) strategy for Strike Pharma’s drug product production of bi-specific antibody and peptides, i.e biological molecules.
You will have responsibility for hands-on management of CMC activities including selection of drug substance manufacture, drug product formulation development and manufacture, and contribution to regulatory submissions. The work involves many contacts both internally and externally, including CDMOs/CMOs/CROs/consultants, which imposes high demands on communication skills and diplomatic ability.
We are looking for someone with an understanding in management of drug development projects and industrial experience from drug development and CMC project management. In addition, you have a strong attention to detail demonstrating ability to troubleshoot, correct, and develop robust drug product processes.
You have a strong driving force with the ability to take your own initiatives. As the company is small, you must have a "can do" attitude and not be afraid to “roll up your sleeves”, with adaptability and understanding of how to navigate and execute in a fast-paced startup. While you are independent, you are also a proactive team player who likes to have a coordinating and project-leading role.
You will report to the Chief Operating Officer.
Key responsibilities
• Provide technical leadership and manage execution of Strike Pharma’s drug product production, process development and manufacturing activities with external CDMOs
• Establish, manage, and lead the CMC development plan together with consultants
• Ensure that drug product is developed to meet company demands and ensure goals are met in cost, time, quality, safety, and operational needs
• Identify and evaluate technical capabilities of CDMOs, mange RfP process and contracting
• Provide CMC oversight as it relates to strategy, project planning and execution, and on-going operations of assigned projects at CDMOs
• Monitor daily activity and implement solutions to solve CMC challenges and ensure cGMP compliance
• Ensure that CDMO and other process activities address drug product needs for pharmaceutical formulation development, toxicology testing and clinical trials
• Review and approve master and executed batch records; lead key process improvements and use analysis skills to identify gaps and drive solutions
• Lead technical investigations to identify root cause and implement corrective actions for drug product related deviations
• Establish plans for analytical / bioassay development and product characterization
• Draft, review or provide input to documents for correspondence with competent authorities (briefing package/scientific advice)
• Extract scientific data and provide appropriate document and batch data review to support regulatory filings; author CMC sections in IND/ IMPD/CTA/NDA
Required Qualifications and Skills
• BSc/MSc or PhD in a relevant discipline e.g. chemistry, biochemistry or pharmaceutics
• Extensive industrial experience from drug development and CMC project management
• Experienced in drug product production and development with the ability to transfer knowledge to external partners; leading tech transfer and scaleup activities
• Experience in leading biological process and analytical development
• Experience in achieving regulatory approval of new drugs or biologicals or strong knowledge of GMP and ICH guidelines; experience authoring regulatory submissions on drug product preferred
• Selection and contracting of subcontractors
• Ability to strategically and pragmatically work with CDMOs to optimize quality, process, operation
• Good knowledge in English, both in speech and in writing
• Experience of Microsoft Office
Professional and Personal Competences
• Takes own initiatives, works independently, makes quick and clear decisions. Initiates and generates activity
• Creates good relationships and networks with stakeholders at different levels, demonstrating interest and understanding for other people
• Writes clearly and correctly in a well-structured and logical way
• Project Management skills: organizational, sets clearly defined objectives, monitors performance against deadlines and milestones. Manages time effectively.
• Adapts to changing conditions and accepts new ideas and initiatives
Other
The position will be located in Uppsala and involves some travel to meetings with researchers, CDMOs and congresses, both inside and outside Sweden. Preferably the place of residence is Uppsala/Stockholm.
Opportunities with the role
Strike Pharma aims to have a major impact on the current rapid development in precision medicine and future individualized treatments of solid tumors. You will be able to work in a small entrepreneurial pharmaceutical company, in the forefront of developing cancer vaccines. In a small start-up biotech company as Strike Pharma, you will participate in strategy discussions together with a highly skilled team, in an important and visible role with great impact.
Contact information
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment Consultants at PeakSearch.
E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379
Application
Apply for the position at PeakSearch website, www.peaksearch.se