Drug Substance - Tech Transfer Lead

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.

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&AMPD, 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&AMP 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