6 days old

Development Associate II

Millennium Pharmaceuticals, Inc.
Brooklyn Park, MN 55443
  • Job Code
    R0020710

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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 II on our Technical Operations Team at our Brooklyn Park, Manufacturing Site.

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 for the process operations and/or analytical methods.
  • Plays a major role in preparation of technical reports and data summaries

ACCOUNTABILITIES:

  • Determine day-to-day priorities, with guidance of Supervisor
  • Perform laboratory activities to support Tech Ops projects following established procedures or developing procedures if needed
  • Maintains and operates lab equipment
  • Records and verifies laboratory data
  • Writes and maintains equipment working procedures
  • May assist in training other Development Associates
  • Draft studies and investigations of moderate scope and work on problems in which the analysis of the situation or data requires a review of identifiable factors
  • Work closely with senior level scientists to design and execute the proper studies
  • May serve as a lead author on reports that have limited scope
  • Maintain data integrity and perform data review activities
  • Responsible for maintaining laboratory supplies and reagents
  • May be involved in some direct manufacturing support as required
  • Complies with the safety guidelines while performing laboratory work
  • Develop a basic understanding of the drug development process
  • Develop an 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 2+ years of relevant experience; or
  • Masters degree in a scientific discipline with 0-3 years of relevant experience

Knowledge, competencies and skills:

  • Previous experience in a regulated environment highly desirable
  • Must be capable of learning, understanding, and explaining scientific rationale behind downstream unit operations utilized in this role
  • Must have demonstrated knowledge of methodologies for analytical-based positions; HPLC, ELISA, RT-PCR, SDS-PAGE, UPLC, spectroscopy, Capillary Electrophoresis (CE-SDS, iCIEF)
  • Position is primarily focused on HPLC, UPLC, and capillary electrophoresis methods to start. Strong aptitude in one of more of these areas is desired.
  • Comfortable in operating laboratory equipment and associated software independently and training of junior level associates
  • Experience with Empower chromatography software a plus
  • Organized and detail-oriented, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility
  • Able to work in a fast-paced environment
  • Ability to make detailed observations, perform analysis of data and interpret results with minimal guidance.
  • Ability to lead projects of limited and well-defined scope
  • Maintains familiarity with relevant scientific literature
  • Self-motivated, developmentally oriented individual
  • Ability to communicate effectively in verbal and written form

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) occasionally. 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 II

Millennium Pharmaceuticals, Inc.
Brooklyn Park, MN 55443

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