AstraZeneca Pharmaceuticals LP Technical Manager – Manufacturing Sciences and Technology / Process engineering in Södertälje, Sweden
Placement: Södertälje, Sweden
At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
We are now looking to hire a talented Technical Manager - Manufacturing Sciences and Technology / Process engineering within Pharmaceutical Technology and Development. You will be part of our team based in Södertälje, Sweden.
Pharmaceutical Technology and Development (PT&D) is the bridge 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.
As Technical Manager you play a key role in our Manufacturing Sciences and Technology (MS&T) group and be part of a multinational team that will support different manufacturing sites around the world. You will be responsible for providing expert technical support for commercial oral solid dose (OSD) products manufactured internally at AstraZeneca and also externally at contractors. You will also be part of a multi-skilled group comprising expertise from a number of scientific disciplines including; Pharmaceutics, Process Engineering, Analytical Sciences, Statistics, and Chemometrics.
Main Duties and Responsibilities
Provide technical expertise to aid the resolution of potential product recall incidents.
Provide technical assessments for proposed product and supply chain changes, highlight technical risks, and recommend work packages needed to support the change(s).
Identify and deliver improvement initiatives for established products
Support creation and delivery of Manufacturability Strategies
Contribute to the preparation and approval of technically complex responses to regulatory questions.
Be responsible for technical oversight and governance during the technology transfer of established products.
Influence decisions at manufacturing sites and at suppliers, e.g. in respect to equipment capital investments
Manage product technical knowledge for a portfolio of products.
Project manage strategic initiatives, including securing sponsorship, resource requirements, stakeholder management, timing and benefits tracking.
Identify opportunities to develop technical capabilities within Operations sites, and provide training to meet agreed capability targets.
Assess the technical capabilities of potential new external manufacturing partners and make supplier selection recommendations.
All these activities have a significant impact on the overall success of Operations by ensuring appropriate manufacturing and testing of AstraZeneca’s commercial products. MS&T secures availability of AstraZeneca’s products for the commercial organisation and patients, impacting on both financial and reputational aspects of the business.
Educated to BSc or PhD level, with working experience in Operations and/or Research & Development and a track-record of successful delivery within a matrix organization.
Detailed understanding of the overall drug development and commercialisation process from development, launch and through life-cycle management.
Strong, broad, oral solid dose background, e.g. formulation, process, analytical and packaging development, marketing submission authoring and/or approval, materials science, manufacturing technology.
Extensive experience of product technology transfer, including required standards and best practices.
Ability to perform root cause analysis for problematic or variable products and identify and deliver improvement opportunities (using formal tools and processes)
Experience in leading quality/technical risk management activities, e.g. QRAs.
Understanding of Operations manufacturing practices.
Understanding of principles, applications and management of cGMP.
Excellent communications and collaboration skills required to manage a multitude of customers and stakeholders, both internal and external to AstraZeneca.
Excellent communications and skills required both in Swedish and English language.
Deep expertise in one or more of the following areas:
Formulation design and development
Manufacturing process design and development
Development and implementation of process analytical technologies
Development and implementation of new manufacturing technologies
Materials sciences (i.e. drug substances and excipients), including potential variability, functional characteristics, and characterization methods.
Training in, or awareness of, lean six sigma, including good understanding of statistical tools and experience of their application.
If you are interested, apply now!
Welcome with your application no later than June 4th, 2017.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.