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This role is focused on providing advanced technical expertise in the manufacturing processes for sterile and biologics products. Oversee the technical transfer of manufacturing...
Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination products to ensure business objectives are met...
Serving as the primary QP at ATI for aseptically manufactured, parenteral products. Coaching and mentoring quality colleagues to develop problem-solving, decision-making, and...
The Quality Director will provide leadership and daily management of the site Quality Assurance, Validation and Quality Control Departments. Quality Director will also be...
Manage a team of Bioprocess Engineers. Responsible for all process procedures, MES recipes oversight and release, ensuring compliance with the related Bioconjugates SOPs....
You lead CMO vendor teams for daily operational management and coordinate meetings with UCB multifunctional teams. You participate in CMO selection for new and existing products...
In this role, you will develop and embed a consistent Quality Culture across all affiliates, ensuring that robust quality systems and processes are in place to support Sobi’s...
This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects...
He/she drives internal and external efforts with the aim of developing, producing and characterizing these therapeutics antibodies for early and late stage clinical programs up to...
This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan. Provide...
Lead and/or supervise the design and development of (oligonucleotide) synthesis and purification processes for the manufacture of API using the most modern technologies. Provide...
This position provides strategic oversight of PV quality systems, audits, and inspections while ensuring compliance with global and regional regulatory requirements. The individual...
The primary responsibilities will include design control activities, new product development, and executing tasks related to maintaining our current products. Protein purification...
Acts as Single Point of Contact/SPOC for all quality related activities at the External Supplier and establishing good working relationships with clear communication and defined...
You will oversee data management activities associated with clinical drug development for all clinical trials in Ascendis’ rare endocrinology portfolio. Furthermore, the duties...
Responsible for ensuring compliance with global regulatory requirements, development of compliance reports/metrics and implementation of corrective/preventative actions to address...