Founded in June 2020, and having recently completed a substantial second round financing, Strike Pharma is now on the path towards commercializing the company’s proprietary ADAC technology platform.
Career opportunities will be posted on this page as they become available.
May 09, 2022
Location: Strike Pharma, Uppsala, Sweden
Role: 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, internally and externally, including CDMOs/CMOs/CROs/consultants, imposing high demands on communication skills and diplomacy.
We are looking for someone with an understanding of management in 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 start-up. 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.
- 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, manage 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, 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
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 treatment vaccines. In a small start-up biotech company such as Strike Pharma, you will participate in strategy discussions together with a highly skilled team, in an important and visible role with great impact.
About Strike Pharma
Strike Pharma aims to use its proprietary Adaptable Drug Affinity Conjugate (ADAC) technology, to take the next step in personalized immunotherapy, enabling development of individualized immuno-oncology treatments based on the genetic profile of each patient’s tumor. Such highly targeted treatments offer the potential to increase therapeutic efficacy and reduce dosage levels thereby minimizing the risk of side effects. Strike Pharma is headquartered in Uppsala, Sweden.
Requests for more information and applications should be submitted to
April 26, 2022
Location: Strike Pharma, Uppsala, Sweden
Role: Scientist experienced in immunological and oncological in vivo and in vitro methodologies
Your essential tasks:
- Participation in research projects and performance of in vivo and in vitro laboratory work
- Responsibility for planning and performance of in vitro and in vivo pharmacology studies
- Analyze, interpret, compile, document and report on research results
- Responsibility for animal breeding
The ideal candidate will have:
A Bachelor’s, Master’s or Ph.D. degree in Immunology, Biomedicine, Biochemistry or similar and a strong interest in practical laboratory work.
Practical experience of independent planning and performance of in vivo laboratory work, in combination with experience in more than one of the following areas:
- In vivo models within immunology and/or oncology (encompassing but not limited to tumor models, adoptive cell transfer experiments, PK/PD studies)
- In vivo treatment (PO, ID, IP, SC and IV)
- Ex vivo preparation of cells from tissues
- Cell-based assays (primary cell and cell line culturing)
- Working with hazardous substances such as chemotherapeutics, including managing risk assessment and SOP writing and implementation
- Ethical applications and relevant guidelines
- Documented history of adhering to the 3R principles
The ideal candidate will be:
- Flexible, quality minded with strong interpersonal skills
- Ethically aware
- An open and communicative team player
- Driven, curious and known for taking initiative
- Fluent in English
Applications should be submitted to [email protected]
Please note that we are screening and interviewing for this position on an ongoing basis and it would be an advantage to apply as soon as possible. For inquiries and more information, please contact: Dr. Tina Furebring, Chief Operations Officer, Tel: +46 (0)768715742