Drug Substance - Tech Transfer Lead
Alten Sverige AB / Biomedicinjobb / Göteborg
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hela Sverige AstraZeneca (AZ) is developing a vaccine to target Covid-19. As part of this effort, the Biologics Global Technical Operations (GTO) group is working with AZ colleagues in R&D to enable the technology transfer of the drug substance (DS) and drug product (DP) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process qualification and commercial manufacture. We are looking to augment the GTO team working on technology transfers with a DS / DP Tech Transfer Engineer. In this role, you will also work with GTO Drug Substance and/or Drug Product technical stewards, R&D process development and quality experts within AstraZeneca and partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO. You will be expected to stay on the program for a minimum of 6 months and up to 12 months. To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements. To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements. The position provides the opportunity to work with a highly motivated and talented global team, working under aggressive timelines to deliver a cutting edge monoclonal antibody manufacturing process to multiple world-class manufacturing facilities and support AZ's efforts in dealing with the Covid-19 pandemic.
ESSENTIAL JOB FUNCTIONS
• WORK WITH DRUG SUBSTANCE/DRUG PRODUCT TECHNICAL STEWARDS AND SMES FROM R&D, QUALITY, VALIDATION WITH AZ AND EXTERNAL PARTNER SITES TO SUPPORT TECHNOLOGY TRANSFER OF DRUG SUBSTANCE PROCESSES (UPSTREAM AND DOWNSTREAM) TO EXTERNAL MANUFACTURING SITES.
• SUPPORT DRAFTING, REVIEW AND APPROVAL OF TECH TRANSFER AND MANUFACTURING DOCUMENTATION SUCH AS RISK ASSESSMENTS, GAP ANALYSES, BATCH RECORDS, STANDARD OPERATING PROCEDURES AND SAMPLE PLANS.
• SERVE AS MANUFACTURING /TECHNICAL POINT OF CONTACT ON SPECIFIC WORKSTREAMS/SUB-PROJECTS, ATTENDING TELECONFERENCES WITH CMOS AND INTERNAL TEAMS, FOLLOWING UP WITH STAKEHOLDERS ON ACTION ITEMS ETC.
• UPDATE PROJECT DASHBOARDS/PRESENTATIONS WITH PROJECT STATUS TO PROVIDE TIMELY COMMUNICATION OF STATUS TO INTERNAL TEAM. PROACTIVELY IDENTIFY RISKS, AND DEVELOP / IMPLEMENT WORK PLANS TO MANAGE / MITIGATE / COMMUNICATE RISK TO SENIOR TECHNICAL TRANSFER LEADS.
• WORK WITH CMOS TO COMPILE AND TREND DS/DP MANUFACTURING PROCESS DATA DURING MANUFACTURING CAMPAIGNS.
• NOTE: THE AZ TEAM WILL BE BASED IN THE US EAST COAST, CMOS RECEIVING TECHNOLOGY TRANSFERS ARE LOCATED IN EU, AND FAR EAST. WILL REQUIRE ABILITY TO WORK FLEXIBLE HOURS TO SUPPORT MULTIPLE GLOBAL TIME ZONES.
MINIMUM REQUIREMENTS:
EDUCATION/EXPERIENCE
DEGREE IN AN ENGINEERING OR SCIENTIFIC DISCIPLINE WITH EXPERIENCE IN BIOPHARMACEUTICAL MANUFACTURING SCIENCE& TECHNOLOGY/ MANUFACTURING/ PROCESS ENGINEERING/ QUALITY. PRIOR EXPERIENCE IN DRUG SUBSTANCE TECH TRANSFERS PREFERRED.
B.S WITH 10+ YEARS OF EXPERIENCE
M.S. WITH 6+ YEARS OF EXPERIENCE
PHD WITH 4+ YEARS OF EXPERIENCE
KNOWLEDGE/SKILLS
Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills
Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations
Ability to work in a complex, dynamic, global environment
ABOUT ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.
We believe in growing together!
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2021-06-02ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2021-06-06
Klicka på denna länk för att göra din ansökanFöretagAlten Sverige AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Alten Sverige AB (org.nr 556420-7453)
Jobbnummer 5784158
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