9 days old

Development Associate III

Millennium Pharmaceuticals, Inc.
Brooklyn Park, MN 55443
  • Job Code
    R0020711

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as aDevelopment Associate III in our Brooklyn Park office.

OBJECTIVES:

  • Will work with other members of the Technical Operations group to lead tech transfers of products into the facility at bench and pilot scale and subsequently to commercial scale
  • 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
  • Will perform hands-on laboratory support, designing experiments for the process operations and/or analytical methods.
  • May lead projects of limited scope that may involve cross-functional collaboration.
  • May provide informal work direction to lower level associates

ACCOUNTABILITIES:

  • Significant involvement in the design, execution, interpretation and troubleshooting of analytical test methods, this may include creating experimental plans and determining the next step in an experiment
  • Identify the needs of the lab and recommending purchases and/or new technologies to supervisor
  • Train 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 and/or analytical technical subject matter expert.
  • Stay current with industry best practices
  • Provide technical support to Manufacturing and/or Quality Control
  • Develop an advanced understanding of the drug development process
  • Develop an advanced understanding of monoclonal antibody cell culture and downstream purification processes
  • Complete mandatory training within required timeframe
  • Perform other duties as assigned

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Preferred combination of education and experience:

  • Bachelors degree in a scientific discipline with 5+ years of relevant experience; or
  • Masters degree in a scientific discipline with 3+ years of directly relevant experience

Knowledge, competencies and skills:

  • Previous experience in a regulated environment is highly desirable
  • 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 in-process analytical and product characterization methods for analytical-based positions including but not limited to HPLC, ELISA, RT-PCR, SDS-PAGE, UPLC, spectroscopy, IEF
  • 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

LICENSES/CERTIFICATIONS:

  • N/A

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.

OTHER REQUIREMENTS:

  • May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection
  • Willingness to travel to various meetings, trainings, or external sites; this could include overnight trips.
  • Requires approximately 5% travel.

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2020-06-30 Expires: 2020-07-29
Sponsored by:
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Sponsored by:
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Development Associate III

Millennium Pharmaceuticals, Inc.
Brooklyn Park, MN 55443

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