Associate Director/Senior Manager, Development Scale Up Center AstraZenecaLocation: Gaithersburg, Maryland, United States
Job reference: R-015412
Posted date: Oct. 13, 2017
If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Senior Manager/Senior Engineer, BioProcess Engineering or Associate Director/Principal Engineer, BioProcess Engineering in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
BioProcess Engineering, Development Scale Up Center (DSC) at MedImmune BioProcess Engineering (BPE) department (within Research and Development) is responsible for scale up, technology transfer, and facility fit assessment of clinical and commercial processes to manufacturing. BPE is also responsible for producing development drug substance material in and data from the pilot scale facility (Development Scale Up Center, DSC). The DSC performs upstream and downstream production, including all activities from vial thaw through formulation of drug substance at pilot-scale. DSC, in collaboration with cell culture and purification development and process engineers within BPE, also evaluates innovative technology, implements novel process control/automation methods and supports scale down model development. The environment is challenging and ever-changing, with varying degrees of process definition and frequent piloting of novel process operations and novel molecule formats.
The leader will provide managerial and technical oversight to the upstream and downstream staff to ensure successful tech transfer and execution of all production-related operations (such as vial thaw, inoculum expansion, cell culture production, centrifugation, chromatography, filtration, UF/DF, media and buffer preparation and equipment CIP/SIP). He/She interfaces with Facilities, cell culture, purification, formulation and manufacturing sciences groups to solve scale up issues and to ensure manufacturing processes are ready for transfer to clinical manufacturing.
The leader is responsible for hiring, training, coaching and developing DSC staff. This includes creation of training plans and rotational assignments, completion of annual performance reviews and preparation of promotion packages. He/She will manage 4-5 direct reports and oversee a staff of 15-17 people.
The leader is responsible for managing the DSC schedule and for reporting process results to customers. The leader attends cross-functional meetings to resolve scheduling conflicts and present data.
The leader is responsible for initiating and driving to completion projects to improve manufacturing success rates and process efficiency. These include facility upgrades, new equipment/automation implementation, improved documentation (batch records, SOPs, work aids), inventory management and personnel training.
The leader maintains a culture of safety in alignment with all Safety Health and Environment guidelines and initiatives, including monthly inspections and safety review meetings. The leader reports SHE related activities at BPE cross-functional meetings.
The leader is accountable for preparing and managing the DSC budget, planning and ordering of raw materials and supplies and serving as the primary contact with key vendors.
The leader presents at internal departmental and cross-functional meetings, and may participate and present at external meetings.
Education: A Bachelors, Masters or PhD Degree in a scientific or engineering discipline is required, with degrees in chemical or biochemical engineering preferred.
Experience required for Senior Manager/ Senior Engineer: The candidate must have at least 15 years (post BS), 13 years (post MS) or 7 years (post PhD) of combined biotechnology industry related process development and/or pilot/clinical/commercial scale manufacturing experience. Experience in managing direct and indirect reports. Experience with pilot scale equipment and use of data management systems is required. Performs work with minimal direction. Contributes to determining technical objectives. Ability to make sound technical decisions to achieve one or more key project objectives. Develops solutions to complex problems. Evaluates multiple options and applies technical knowledge broadly. Frequent internal and external contacts with key vendors and customers. Active in external organizations.
Experience required for Associate Director/Principal Engineer: The candidate must have at least 17 years (post BS), 15 years (post MS) or 11 years (post PhD) of combined biotechnology industry related process development and/or pilot/clinical/commercial scale manufacturing experience. Experience in leading diverse terms and managing across levels (from pilot plant technician to Senior Manager). Experience with pilot scale equipment and use of data management systems is required. Performs role without significant direction. Interprets, executes and recommends new procedures, automation and/or equipment in alignment with departmental and corporate goals. Ability to make sound technical decisions in line with overall strategy. Effectively presents to Senior Leadership. Ability to independently lead innovation, change and drive for results. Anticipates future scientific and business opportunities and trends. Takes appropriate risks in implementing technology and automation platforms. Skilled in customer relationships and collaboration/teamwork as team leader.
Knowledge of and experience with cell culture and fermentation operations such as seed and inoculum expansion, microbial and mammalian cell production, media preparation, aseptic processing, and centrifugation and filtration harvest methods is preferred. Knowledge of and experience with purification operations such as chromatography operations, column packing, ultrafiltration, diafiltration and viral filtration is preferred.
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.