Director of Technical Operations - OxThera
Do you want to devote yourself taking part in the work developing new drugs for patients with severe kidney disease with no cure today? You will work with development of a treatment for a disease that particularly strike children.
Your work is to manage a team with a broad scope including Sourcing and supply, Management of GMP processes, QC analyses, CMC Regulatory and Budget and resources.
Sourcing and supply
Your key responsibility as Director of Technical Operations will be to build and manage the team for sourcing GMP manufactured product for clinical trials, and at a later stage, for commercial use. With your team, ensure strong and sustainable supply chains for the OxThera products.
- making forecasts, ordering batches and managing stock
- manage contact and supply operational meetings with CMOs and internal functions to ensure supply of product
- coordinate manufacturing of starting materials, drug substance, drug product and finished goods
- management of all GMP manufacturing and QC testing activities at OxThera’s CMOs and CRO’s to meet US and EU regulatory expectations
- In close communication with QA, establish strong relationships with critical manufacturing and testing partners and ensure commercial readiness at CMOs and CROs for US and EU markets
- support the distribution and logistics function for commercial launch
Management of GMP processes
You will have a clear ownership of drug substance, drug product and finished goods GMP processes at all scales and stages. Together with your team of SMEs (contract manufacturers and contract QC analysis laboratories) and project managers, you will lead scale-up, GMP process validation and transfer activities.
Establish analytical Quality Control (QC) testing based on reception of validated analytical methods from Process R&D.
Ensure delivery of high quality documentation to support CMC registration dossier compilation.
Budget and resources
Responsibility for Technical Operations team resources. Forecasting and budgeting of clinical and commercial supply, including stock management. Process scale-up, validation and transfer activities will be within your budget. Budgeting and planning will be made in close collaboration with key functions and the leadership team.
You will report to the COO of OxThera.
Desired Education, Skills and Experience
- Strong (minimum 15+ years) background in clinical and commercial stage manufacturing of biological pharmaceutical products.
- PhD or MSc degree in combination with strong experience in life sciences or related fields.
- Strong experience of cGMPs and relevant regulatory guidelines in the US and Europe.
- Experience with preparation of CMC sections for regulatory submissions worldwide is an advantage.
- Strong experience with preparation activities for commercialization such as pre-approval inspections, building launch inventory, and developing commercial supply and quality agreements.
- Excellent understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirements and SOP’s.
- Good strategic, analytical, problem-solving and organizational skills. High emotional intelligence, sound temperament and professional attitude. Common sense and judgement.
- Excellent communication skills, both verbal and written, together the ability to interact effectively will all internal and external functions.
- Outstanding leadership and management capabilities to build, motivate and manage. Personal alignment with OxThera’s values.
Application and more information
Please call Knut Natt och Dag on +46 722 16 68 00 if you have any questions. Are welcome with your application by e-mailing your CV and personal letter to firstname.lastname@example.org as soon as possible. We are working continuously with this recruitment project and would like to receive your application as soon as possible. Write ”Director of Technical Operations” in the subject field.
OxThera is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting and consulting company within Life Sciences specialized in positions within the pharmaceutical industry – from early discovery through pharmaceutical development and clinical development to the market place. We are members of SwedenBIO and Medicon Valley Alliance. You can read more about us at or website – www.aktivia.se