Development Associate III, Upstream Technical Operations


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Development Associate III in our Brooklyn Park, Minnesota office.


Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Development Associate III working on the Upstream Technical Operations team, you will be empowered to lead tech transfer of products into the site and provide manufacturing technical support, and a typical day will include:


OBJECTIVES:
•The Technical Operations Group is responsible for leading tech transfer of the products into the facility at bench and pilot scale and subsequently to commercial scale
•The group is responsible for manufacturing technical support including batch records, deviations, change controls, investigations, life cycle management, scale down modelling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings
•The current position will be responsible for performing hands-on laboratory support for upstream process operations.


Primary Responsibilities include:
•Significant involvement in maintaining, operating, and troubleshooting lab equipment and instrumentation used for cell passage, bioreactor (bench and pilot scale), and harvest operation and process monitoring. Act as equipment owner as needed.
•Design and execute lab experiments to support tech transfer, scale down models, and lifecycle management activities
•Maintain day to day lab operation including inventory management and scheduling as well as identifying and implementing new technologies to establish the lab as a center of excellence
•Train and provide direction to junior level development associates
•Ensure that procedures, lab equipment, data, documentation, activities etc within the lab are well-controlled and suitable for their intended use
•Provide input for and adhering to project tasks and time-lines
•Presenting and discussing data and experimental conclusions at group and departmental meetings and internal seminars, thus demonstrating confidence and understanding of the scientific rationale of the experimental designs
•Author protocols and technical reports to ensure high scientific standards
•Contribute to deliverables and interfaces with tech transfer teams in the role of process subject matter expert.
•Stay current with industry best practices
•Provide technical support for GMP Manufacturing
•Data tracking and trending in support of continued process verification
•Develop an advanced understanding monoclonal antibody cell culture manufacturing processes


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
•Bachelor’s degree in a scientific discipline with a minimum of 5 yrs, MS with at least 3 yrs of directly related experience in a relevant discipline is required, PhD with 0-2 yrs.
•Demonstrated capability of working in a fast paced development environment.
•Well organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility
•Strong knowledge of the unit operations commonly used in monoclonal antibody manufacturing operations for upstream (cell culture) or downstream (purification) based positions: aseptic technique, experience propagating mammalian cells, bioreactor operation, column chromatography, ultrafiltration/diafiltration processes
•Current knowledge of relevant regulatory requirements related to biologic manufacturing and analytical methods to ensure compliance in all activities
•Ability to demonstrate a high degree of productivity even when doing difficult experiments in an independent manner
•Has considerable experience with instrumentation software administration and computerized systems.
•Ability to manage and organize complex technical problems
•Ability to analyze and exercise independent judgement on complex projects which require thorough evaluation of multiple factors and approaches.
•Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
•Willingness to perform hands-on laboratory work
•Willingness to remain flexible in work scope to achieve group objectives
•Prior experience in GMP manufacturing support desired
•Proven ability to troubleshoot equipment failures
•Experience with data tracking and trending, principal component analysis, or DOE a plus (statistical software experience preferred).
•Prior experience with SIP/CIP operations desired


PHYSICAL DEMANDS:
•In general, the position requires a combination of sedentary work and walking /standing for periods of time in Manufacturing Sciences lab environment.
•May require occasional lifting up to 40 lbs.


TRAVEL REQUIREMENTS:
•Willingness to travel to various meetings, trainings, or external sites; this could include overnight trips.
•Requires approximately 5% travel.


WHAT TAKEDA CAN OFFER YOU:

•401(k) with company match and Annual Retirement Contribution Plan
•Tuition reimbursement
•Company match of charitable contributions
•Health & Wellness programs including onsite flu shots and health screenings
•Generous time off for vacation and the option to purchase additional vacation days
•Community Outreach Programs


Empowering Our People to Shine


Learn more at takedajobs.com.


Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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