Sr. Specialist/Engineer III, External Manufacturing, US

  • location: Norwood, MA
  • type: Permanent
  • salary: $110,000 - $125,000 per year
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job description

Sr. Specialist/Engineer III, External Manufacturing, US

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Norwood, Massachusetts
job type: Permanent
salary: $110,000 - 125,000 per year
work hours: 8 to 4
education: Bachelors
 
responsibilities:
Reporting to the Senior Manager of US External Manufacturing, the Senior Specialist/ Engineer III this individual will be part of a team responsible for our manufacturing activities at 3rd-party contract manufacturing organizations (CMO).

RESPONSIBILITIES

  • Ensure operational and technology transfer activities are performed completely and compliantly at CMOs to deliver a quality product and meet our requirements
  • Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.
  • Approve instructions relating to external production operations and ensure their strict implementation by the CMOs
  • Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate our requirements.
  • Coordinate and perform the reviews for process performance and Key Performance Indicators at CMOs.
  • Drive for and implement agreed continuous improvements at CMOs.
  • Coordinate reviews and approvals of various documentations from CMOs.
  • In collaboration with Quality, Technical Development, and MS&T, coordinate investigations and troubleshooting efforts at CMOs.
  • Write or revise the appropriate GMP documentations.
  • Frequently visit and maintain presence at the external partners' sites (as global travel situation allows).
  • Performs other administrative duties as required.
 
qualifications:
Here's What You'll Bring to the Table:

  • Bachelor's degree in Engineering or Sciences and 5-8 years or MS with 2-5 years of industry experience.
  • Considerable understanding of concepts and principles related to drug substance manufacturing is preferred
  • Excellent communication skills (verbal and written) to collaborate with CMC Management in a dynamic, cross-functional matrix environment.
  • Well organized - a natural ability to be organized in how you think, communicate and conduct your work
  • You drive for results - you set a high bar for yourself and others
  • Good critical thinker that can anticipate the needed next step and therefore can work independently
  • A curious mindset that allows you to constantly learn and challenge the status quo
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
 
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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