Alligator Bioscience is a research-based biotechnology company that develops antibody-based drugs for the treatment of cancer. The company specializes in the development of tumor-targeted immunotherapies, in particular agonistic mono- and bispecific antibodies. In immunotherapy, the patient's own immune system is activated to cure cancer. The term tumor-targeted means that the drug is administered or designed in such a way that the immune activating effect is localized to the tumor. This results in a favorable power and safety profile.
Alligator is primarily active in the early stages of drug development, from concept to clinical phase II studies. This includes, among other things, the identification of new points of attack for drugs, the development and optimization of new drug candidates, the evaluation of preclinical efficacy and safety, and finally confirmatory clinical studies on cancer patients.
Alligator's core business is focused on research and early development of drug candidates. In the research phase, Alligator develops new mono- and bispecific antibodies with its technology platforms ALLIGATORGOLD ® , ALLIGATOR-FAB ™, FIND ® and RUBY ™. Alligator's strategy is to develop its drug candidates through Phase II/III, but is open to the possibility of outlicensing or entering into partnerships during the previous clinical phase.
Recently, Alligator Bioscience and MacroGenics entered into a research collaboration to develop a novel Immunotherapy.
Alligator was founded in 2001, is based in Medicon Village in Lund and the company is listed on Nasdaq Stockholm Mid Cap (ATORX).
For more information about the company, please visit http://www.alligatorbioscience.com
TILLSATT - Director Quality Assurance
Company: Alligator Bioscience AB
Position: Director Quality Assurance
Location: Lund, Sweden
The position as Director Quality Assurance
The Director QA is responsible to encourage and improve the QA mindset in the organization which means you will have a broad scope of responsibilities, all related to the regulatory compliance. You are responsible for Alligator’s Quality Management System, deliver solutions to aid compliance within the daily work of the organization and support colleagues in quality issues. Being part of a small company also calls for an operational and truly flexible mindset.
The role involves close interactions with Clinical Operations, Regulatory Affairs, CMC, the Chief Medical Officer and other internal stakeholders as well as external support organizations e.g. consultants and partners at an international level. This puts high demands on the understanding of different cultures and great diplomatic skills.
We are looking for a highly skilled and motivated person with a solid QA background, experience from Life Science preferably Pharma/Biotech, and with excellent ability to gain and maintain trust from others as well as to engage and motivate the organization. You need to be decisive, have good communicative and collaborative skills and strong ability to drive performance. In addition, you will play an important role in actively supporting the company in all QA related issues.
You have a strong drive with the ability to take initiatives and work in a structured and efficient way. Given the size of the company, you must have a “can-do attitude” and not be afraid to roll up your sleeves. You are independent but also an excellent team player with high personal and professional integrity. You must be able to make decisions and provide others with a clear direction.
It is important that you embody our core values: Respect, Commitment and Innovation. In return you will find a culture based on openness, mutual respect and dedication with the possibility for individual development and growth as well as the chance to make a true difference for cancer patients around the world.
You will report directly to the Chief Operating Officer R&D.
Essential tasks will include but not be limited to:
• Overall responsibility for maintaining and improving the Quality Management System (QMS), QA mindset and processes in the company
• Develop and establish policies and standards that convey the best practices in the company
• Ensure that quality standards are met
• Support CMC, non-clinical development, and Clinical Operations to ensure quality and compliance with regulatory requirements internally and for outsourced activities
• Training and information about GxP and Alligator´s QMS
• Responsible for generation of the annual audit program related to GMP, GLP and GCP activities
• Plan, perform and follow up both internal and external audits in close collaboration with stakeholders
• Dialogue with authorities, CROs and partners in QA related issues
• Ensure consistent reporting of quality issues, including quarterly and annual quality reports
• Provide guidance and leadership to management and project teams regarding QA
• Act as main contact for external Qualified person (QP), and other quality related dialogues
Experience and qualifications
We expect the ideal candidate to have:
• Academic degree within Life Science/Health Care
• Lagt till: Experience from the pharmaceutical/biotech industry
• At least 5 years professional experience in the area of clinical quality assurance including system and study audits at e.g. Clinical Research Organisation, Contract Manufacturing Organizations or clinical trial sites
• Good overall understanding of pharmaceutical development
• Knowledge in the areas of GCP, GLP and GMP and national and international regulations
• Fluent in oral and written English
• Experienced user of MS Office package
Following experience is an advantage:
• Clinical trial management
• Immuno oncology
• CMC manufacturing of biologics
Required skills and personal characteristics
• Provides others with a clear direction
• Builds wide and effective networks of contacts inside and outside the organisation, relates well to people at all levels
• Writes clearly and correctly in a well-structured and logical way
• Works strategically to realise organisational goals
• Sets high standards for quality and quantity, works in a systematic, methodical and orderly way
The position as Director Quality Assurance will be based in Lund with some flexibility to work from home.
Opportunities with the role
Alligator is a biotech company dedicated to the ultimate goal of curing cancer. Being part of a small organization offers high visibility, broad responsibilities, and an opportunity to make a real impact. There is an informal and personal atmosphere at Alligator where everybody helps one another to reach even greater achievements together. Alligator is an exciting and dynamic place to work.
The combination of wide-ranging growth opportunities, Alligator’s unique position and the company’s core values has created a strong brand in both the academic community and the international pharmaceutical industry.
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
M: +46 706 152 772
M: +46 701 725 379
Apply for the position at http://www.peaksearch.se