Senior Technical Manager- Biologics Drug Substance- Operations
Would you like to apply your expertise to impact the Global Biopharma Technology Operations in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new insights to life.
In the Biologics Global Technical Operations (GTO), we work closely with AstraZeneca's manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline.
As Biologics Drug Substance Manufacturing Technical Manager, you will provide technical expertise and leadership in two areas:
- Drive transfer and harmonization of Drug Substance (DS) Raw Material Specifications across network
- Support process technology transfers and ongoing commercial manufacturing and process performance reviews at CMOs
This role is at the Senior Manager level and will report directly to the Senior Director, Global Drug Substance Network Lead. While this position does not have direct reports, you will be encouraged to lead cross-functional teams and connect across internal organizations and CMOs as required.What you'll do:
Essential for the role
- Work with QC/QA/R&D subject matter authorities to drive a detailed review of raw material specifications for late phase clinical manufacturing processes being transferred into Operations Manufacturing facilities in the Biologics Network. Lead Raw Material transfer workstream as part of drug substance technology transfers for AZ products (clinical and commercial) to external MFG site (CMOs) including:
- Work with RM QC/QA/Technical specialists at CMOs to transfer Raw Materials (RMs) specifications and raw material test methods.
- Evaluate potential alternative RMs proposed by the CMO based on process needs, quality/compliance, testing/release lead time considerations.
- Author global change controls in the Quality management system and work with internal and external sites to implement.
- Partner with R&D technical/QC/QA SMES and functional groups to drive alignment in RM methods and specs across the portfolio
- Work with Drug Substance Technical Stewards to support technology transfer of drug substance processes (upstream and downstream) into 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.
- Help resolve deviations at CMOs by interfacing with relevant manufacturing site(s), Quality/Regulatory, Engineering, Validation, and Development and support implementation of solutions across the network.
- Work with CMOs and internal sites to compile DS manufacturing process data and key process indicators across the DS network, and help identify and implement continuous improvement and risk mitigation actions.
- Degree in an engineering or scientific subject area with experience in biopharmaceutical Manufacturing/ Quality/ Commercial technology transfers
- B.S with 12+ years of experience
- M.S. with 8+ years of experience
- PhD with 6+ years of experience
- Solid understanding of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
- Experience and understanding of incoming RM quality management procedures in the industry and regulatory expectations.
- Knowledge of compendia (USP/NF, Ph. Eur. and JP) and RM release test methods for raw materials, disposables, and components used in biologics manufacturing process is strongly preferred.
- Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills
- Strong interpersonal skills, with the ability to collaborate in cross functional teams across multiple organizations
- Ability to work in a sophisticated, multifaceted, global environment
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Wonderful! We have one seat available and we hope it's yours.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.
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