AdjuTec Pharma (AdjuTec)is a new start-up with ambitions of being part of the global solution to fight antimicrobial resistance (AMR) through development of first-in-class antibiotic resistance technology. This is an opportunity for the right person to participate in building a Norwegian biotech company together with a small and dedicated team of enthusiastic people.
Head Pharmaceutical Operations
Type of Employment
AdjuTec is looking for Head of Pharmaceutical Operations to lead activities within CMC, preclinical and regulatory. The priority will be to document synthesis, formulation and manufacturing of our lead drug candidate (APC148) and pipeline products, to support the preclinical and clinical programs. In addition, to lead regulatory interactions with health authorities, e.g. FDA, EMA, for CMC scientific advice and ensure that marketing submissions are fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
The preferred candidate to lead these operations must be able to proactively engage with internal and external stakeholders and be a key resource for advising on non-clinical strategy for the Company. AdjuTec’s lead product candidate APC148 is currently in preclinical development that will support a clinical program starting in 2023. AdjuTec’s follow up drug candidates are in lead discovery phase.
- Overall responsibility for all preclinical activities in close collaboration with the company’s CSO
- Priority on planning and execution on CMC/regulatory activities to meet the requirements for starting clinical studies
- Management and collaboration with established CMO and vendors
- Selection and management of new partners and vendors
- Establish a quality system for CMC activities, together with QA/QC responsible, to successfully meet internal audits and inspections from health authorities
- Development of preclinical related SOPs in collaboration with QA/QC responsible
- Accountability for assigned budgets for preclinical, CMC and regulatory activities
- Building a high-performing team to successfully drive pharmaceutical operations according to appropriate quality standards including international regulatory requirements
Qualifications and experience:
The holder of this position should have the following documented qualifications and experience:
- A minimum of M.Sc. Chemistry/Pharmacy/Biology or equivalent education
- Industrial experience in key aspects of CMC product development such pharmaceutical or analytical development.
- Good understanding of Regulatory submissions (e.g. IND’s, IMPD’s NDA’s)
- Experience from preclinical operations in a biotech company and/or from work with similar development stage products
- Experienced with current Good Manufacturing Practice requirements
- Experience with antimicrobial products will be advantageous
- Fluency in English and preferably working knowledge of Norwegian
- A successful candidate has a demonstrated ability to deliver on ambitious goals, have leadership skills and relevant scientific competence
- The position will demand flexibility, creativity and desire to work closely with a small team to reach common goals. The ability to network, have a systematic and strategic approach as well as being a good communicator will be appreciated
- The holder of this position will be based at AdjuTec Pharma AS, Ullernchausséen 64, 0379 Oslo. The position will report to the Chief Executive Officer (CEO) of the Company.
Please submit your written application to Bjørn Klem, email email@example.com, describing why AdjuTec should appoint you and how you can contribute.
AdjuTec is a privately held Norwegian company based at Montebello, Oslo. The company is committed to developing novel, innovative antimicrobial resistance breakers to secure sensitivity to antimicrobial agents. The AdjuTec team includes from 1st July 2021 a CEO, a CSO (gründer), consultants and the Board of Directors. The Company has recently secured private and public financing for company activities through 2022. The Company expects to recruit a core team of people within the same time-frame.
AdjuTec has a long-term research R&D relationship with University of Oslo and collaborates with Synthetica, Oslo on CMC activities. For other preclinical activities the Company has a collaboration with Evotec, Germany.
A common way for bacteria to defend themselves is by producing enzymes that inactivates antibiotics. AdjuTec’s lead product candidate APC148 is a novel metallo-ß-lactamase (MBL)-inhibitor without direct effect on the bacteria. The product will be administered together with antibiotics to patients with complicated bacterial infections, to secure antibiotic sensitivity. Such adjuvant technologies are more attractive to the marked compared to new antibiotics, due to rapid development of resistance to the latter.