Associate Principal Scientist
AstraZeneca AB / Kemistjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla kemistjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos AstraZeneca AB i Södertälje,
Stockholm,
Solna,
Göteborg,
Mölndal eller i
hela Sverige We have an exciting opportunity for Associate Principal Scientist - Analytical within Technical Operations, Science and Innovation (TOSI), a key function of our Pharmaceutical Technology & Development (PT&D) organization.
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.
The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle. TOSI is a multi-skilled global organization based in 13 locations in 7 countries, which provide technical leadership and subject matter expert support to AstraZeneca commercial small molecule drug products. Our technical support and expertise spans from formulation, process engineering, analytical, and statistics to devices, packaging and manufacturing technology strategy. The areas in which we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, product launches and regulatory submissions, product robustness, validation and risk evaluation.
What you'll do
As Associate Principal Scientist you will be responsible to provide analytical subject matter expert support to a portfolio of oral solid dosage products across their commercial lifecycle at global level. Using your knowledge in analytical science and analytical technologies, you will provide expertise and leadership to ensure efficient and effective support to internal and external manufacturing sites and testing laboratories located in multiple countries. In this role, you may be the product technical lead for one or more drug products, coordinating TOSI activities and being the main point of contact for our customers as well as representing TOSI in the Global Supply Teams (GST) and/or Pharmaceutical Teams (PT).
We will also rely on you to train and mentor colleagues and partners in analytical methods used in your expert field.
Based on your experience and skills, your main accountabilities will include:
* Being the accountable analytical lead for a group of OSD products and supporting all analytical lifecycle activities to ensure testing methods, specifications and control strategies are and remain fit for purpose and aligned with technology advancements and regulatory requirements.
* Working as analytical SME in multi-functional cross-site teams supporting analytical technology transfer projects to internal and external manufacturing and testing sites.
* Leading and assessing complex technical changes and playing a proactive role in seeing opportunities for analytical method improvements, including automation.
* Leading analytical issues investigations in QC laboratories and manufacturing sites.
* Planning and driving or coordinating laboratory work when needed to support projects and products.
* Providing SME support during the regulatory file authoring and the interaction with local authorities for regulatory submissions, variations and license renewals.
* Leading analytical risk assessments related to nitrosamines, extractables & leachables elemental and organic impurities.
* Developing solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision and analysis.
* Providing Technical leadership to Issue Management Team (IMT).
* Supporting the definition of analytical standards impacting commercial products, specific to regulatory expectations and good business or quality standards (including pharmacopeial standards).
* Providing project resource estimations to support the budgeting process.
Essential requirements
* MSc or PhD degree or equivalent experience, complemented with considerable experience in an appropriate subject area such as Analytical Chemistry, Pharmacy, Pharmaceutical Sciences or similar.
* Strong technical leadership and interpersonal skills and a proven track record to lead and collaborate across teams, functions and locations.
* In-depth understanding of analytical sciences in the Pharmaceutical Industry, applied to OSD products, including raw materials, intermediates and final products.
* Good understanding of control strategies and specification setting and proven knowledge of a broad range of analytical techniques.
* Experience in analytical testing of OSD products, including related analytical methods validation, transfer and optimization across the lifecycle.
* Experience in issue investigation and change assessment from analytical point of view. Good knowledge of standard tools for root cause analysis (PPS, Level 0, etc.)
* A thorough understanding of principles, applications and management of SHE and cGMP.
Desired for the role
* Experience in or exposure to multiple subject areas in CMC and related functions (e.g. product development, on-market support, manufacturing and testing)
* Business acumen and capability to understand business cases in subject matter areas.
* A good understanding of the overall drug development and commercialization process from development, launch and through life cycle management
Why AstraZeneca
At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next... We welcome your application no later than February 6th, 2024.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2024-02-02
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-190028".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
galia.nystrom@astrazeneca.com Jobbnummer 8413779
Observera att sista ansökningsdag har passerat.