Principal Scientist
AstraZeneca AB / Biomedicinjobb / Mölndal
2023-04-27
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hela Sverige Visa alla jobb hos AstraZeneca AB i Mölndal,
Göteborg,
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Stockholm eller i
hela Sverige At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Pharmaceutical Technology and Development (PT&D) is the organization that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AstraZeneca's commercial drug substances and products to ensure we successfully supply medicines to patients.
Inhalation Product Development (IPD) sits within PT&D and is responsible for the development of inhalation products including combinations. Inhalation Product Development delivers the therapies of the future through scientific leadership in drug delivery, formulation and manufacturing the final drug product.
We are now seeking a Principal Scientist to join our outstanding team.
This role leads pressurized metered dose inhaler (MDI) and dry powder inhaler (DPI) development and on-market support activities. The ideal candidate will have development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls. Moreover, knowledge and experience in how suspension MDI formulations interact with the valve, can, and actuator is required. In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals. Experience authoring international regulatory documents is desired.
What you'll do
Lead a global team of functional leads comprised of, at a minimum, analytical, manufacturing, product development, and device representatives for a complex global product development program
Adhere to the Product Development Process and deliver project objectives on time and to quality and budget
Plan project activities and deliverables, in collaboration with PM, with appropriate input from IPD and BPD functions and IPD LT endorsement
Communicate project delivery and technical risks to IPD LT (and IPD PDD LT) and propose mitigations; advocate for project and product opportunities
Support global harmonization efforts across inhalation portfolio and within inhaled biologic programs
Lead project team utilizing lean tools such as communication (Tier process), investigations (PPS, Level 0), and productivity (Agile PM) tools
Lead authoring for regulatory dossiers including INDs, CTAs, briefing documents, BLAs, MAAs, etc.
Represent the IPD Product Development Team at the Pharmaceutical Team level and within functional stakeholder meetings, providing technical advice in the advancement of the development of the product
Collaborate closely with IPD functional heads on a routine basis to support rapid and agile responses to project challenges and opportunities
Essential Requirements
Master's degree or equivalent professional qualification
Knowledge of the drug discovery and development process, developments within the industry and within own broad area of expertise
Understanding of local compliance systems regulations
Ability to provide guidance and advice on future strategy
Understanding of patent and IP strategies
Substantial knowledge of the product development process
Proven track record of project work in inhaled development
Excellent communication skills
Proven track record of talent development
Experience of coaching people
A habit of driving continuous improvement
Excellent written and verbal communication and presentation skills in English
Desirable requirements
Excellent negotiation, collaboration and interpersonal skills
Ability to analyse and interpret complex situations and provide clear strategic directions for others
Så ansöker du Sista dag att ansöka är 2023-05-07
E-post:
galia.nystrom@astrazeneca.com Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-164910".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Pepparedsleden 1 (
visa karta)
431 83 MÖLNDAL
Arbetsplats AstraZeneca Göteborg
Jobbnummer 7706317
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