About Corline Biomedical AB
Corline was founded in 1991 by three former employees of the Swedish pharmaceutical and biotechnology company Pharmacia with the goal to commercialize an extra corporeal blood pump. The blood pump used a unique and proprietary coating technology that later became the basis of the Corline’s offering to the medical device industry – the Corline Heparin Surface, CHS™. During 1997-2005 Corline delivered more than 100,000 coronary stents coated with CHS™.
As a result of a research partnership with Uppsala University, a new line of business was added where heparin-based compounds are used to treat biological products to attenuate immune thrombotic response in relation to transplantation and vascular repair. Through this partnership Corline developed its technology to allow heparin to be immobilized onto living cells and tissue segments without compromising their viability, thus improving whole organ and cell transplant outcome.
Corline’s strategy is to develop pharma projects through clinical phase II, and thereafter evaluate whether to proceed in partnership or on its own towards registration and commercialization. The company’s lead candidate for improving outcome of kidney transplantation - Renaparin® - is in phase 1 clinical development. Cytoparin™ - a drug candidate being developed for cell transplantation to diabetes type 1 patients, is approved by the Swedish MPA to start its phase 1 clinical trial. Renaparin® has gained Orphan Drug designation both by FDA and EMA and has been awarded a 2.4 MEUR grant by the EU commission through its H2020 programme.
Corline maintains its role as supplier to the medical device industry in parallel with developing its pharmaceutical projects, and during 2018 a letter of intent was signed with a North American customer for the application of CHS™ to ablation catheters.
Further information about the company can be found on http://www.corline.se
Head of Chemistry Manufacturing and Controls
Position: Head of Chemistry Manufacturing and Controls (CMC)
Company: Corline Biomedical AB
Location: Uppsala, Sweden
Reports to: CEO
Head of Chemistry Manufacturing and Controls (CMC)
The Head of Chemistry Manufacturing and Controls is accountable to manage the company’s CMC related activities across the product portfolio (with priority on the lead product - Renaparin®), including characterization, process chemistry, chemical manufacturing, formulation, control and supply of clinical trial materials.
Main responsibilities
• Overall responsibility for drug substance (API) and drug product (DP) activities from preclinical development through clinical supplies for Phase 3 registration studies
• Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of API and DP in support of ongoing clinical programmes
• Develop and implement strategy for optimizing and controlling quality of API and DP using both internal production, analytical and quality resources, as well as external CROs and CMOs
• Prepare API and DP specifications
• Formulation development for supply to clinical programmes
• Project and plan API and DP need for preclinical and clinical programmes, and associated budgets
Required profile
We are looking for a person with experience from leading successful CMC projects. The person needs to be highly motivated with a strong drive and good verbal and written communication abilities. 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 goal.
Qualifications
• MSc in Technical/Natural Sciences, Chemistry and or Pharmaceutical Science
• Demonstrated ability to successfully lead CMC development in clinical stage pharma projects
• Experience in managing CROs/CMOs for the manufacture of cGMP APIs and/or DP
• Long experience from the pharma or biotech industry, including a minimum 3 years’ experience in a CMC management role
• Excellent written and verbal communications skills, as well as interpersonal and management skills, including leading both internal and external teams
• Fluency in oral/written Swedish (or other Scandinavian language) and English
Competencies
• A good presenter with strong communication skills
• Ability to organize, plan and implement activities according to established goals
• True team player being able to operate successfully across all levels in the organization
• Good interpersonal skills
• Used to work both independently and be self-motivated as well as working in a team
• Responsive and an ability to identify, create and maintain new networks in order to achieve the business area objectives
Role opportunities
• Corline is a biotech company in the forefront of research within transplantation
• Corline is listed on the Nasdaq First North Exchange, and provides an exciting and dynamic place to work
• The possibility to work for a small and growing company together with a very dedicated team
• Being part of the management team
• This versatile and newly established position provides room for initiative and influence
• The right candidate will be part of an experienced and professional team with a great spirit
Contact
For further information about the position, please contact Marta Frick, Senior Recruitment consultants at PeakSearch.
E-mail; marta.frick@peaksearch.se Mobile: +46 70 386 89 69
Company: Corline Biomedical AB
Location: Uppsala, Sweden
Reports to: CEO
Head of Chemistry Manufacturing and Controls (CMC)
The Head of Chemistry Manufacturing and Controls is accountable to manage the company’s CMC related activities across the product portfolio (with priority on the lead product - Renaparin®), including characterization, process chemistry, chemical manufacturing, formulation, control and supply of clinical trial materials.
Main responsibilities
• Overall responsibility for drug substance (API) and drug product (DP) activities from preclinical development through clinical supplies for Phase 3 registration studies
• Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of API and DP in support of ongoing clinical programmes
• Develop and implement strategy for optimizing and controlling quality of API and DP using both internal production, analytical and quality resources, as well as external CROs and CMOs
• Prepare API and DP specifications
• Formulation development for supply to clinical programmes
• Project and plan API and DP need for preclinical and clinical programmes, and associated budgets
Required profile
We are looking for a person with experience from leading successful CMC projects. The person needs to be highly motivated with a strong drive and good verbal and written communication abilities. 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 goal.
Qualifications
• MSc in Technical/Natural Sciences, Chemistry and or Pharmaceutical Science
• Demonstrated ability to successfully lead CMC development in clinical stage pharma projects
• Experience in managing CROs/CMOs for the manufacture of cGMP APIs and/or DP
• Long experience from the pharma or biotech industry, including a minimum 3 years’ experience in a CMC management role
• Excellent written and verbal communications skills, as well as interpersonal and management skills, including leading both internal and external teams
• Fluency in oral/written Swedish (or other Scandinavian language) and English
Competencies
• A good presenter with strong communication skills
• Ability to organize, plan and implement activities according to established goals
• True team player being able to operate successfully across all levels in the organization
• Good interpersonal skills
• Used to work both independently and be self-motivated as well as working in a team
• Responsive and an ability to identify, create and maintain new networks in order to achieve the business area objectives
Role opportunities
• Corline is a biotech company in the forefront of research within transplantation
• Corline is listed on the Nasdaq First North Exchange, and provides an exciting and dynamic place to work
• The possibility to work for a small and growing company together with a very dedicated team
• Being part of the management team
• This versatile and newly established position provides room for initiative and influence
• The right candidate will be part of an experienced and professional team with a great spirit
Contact
For further information about the position, please contact Marta Frick, Senior Recruitment consultants at PeakSearch.
E-mail; marta.frick@peaksearch.se Mobile: +46 70 386 89 69