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Scientist, Biopharma Method Transfer – Remote (JP10272)

Boston, MA · Biotech/Pharmaceutical
Job Title: Scientist, Biopharma Method Transfer – Remote (JP10272)
Location: Boston, MA. (100% Remote)
Employment Type:  Contract
Business Unit: Integrated Commercial Attribute Sciences
Duration: 12 months with likely extension
Posting Date: 5/17/2022
 
3 Key Consulting is hiring a Scientist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Ideal candidate Master in Biochemistry, Analytical Chemistry, Physical or Life Sciences. Strong understanding of method validation/transfer for methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)

Biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Attribute Sciences group within Process Development is seeking a Scientist. The scientist will be responsible for the data verification, drafting, reviewing, and compilation for method transfer and method validation protocols and reports. The position will be a documentation centric role and the candidate will need to have experience with document management systems.

The Scientist role in Commercial Process Development will be part of a team responsible for authoring method transfer and method validation protocols and reports for late stage programs for the following method platforms: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocols and reports will be authored according to regulatory and industry guidelines (i.e., ICH). This individual will support clinical and commercial locations throughout the company.
 
Why is the Position Open?
Supplement additional workload on team.
 
Top Must-Have Skill Sets:
  • Knowledge of analytical method in Pharma/Biotech
  • Excellent communication skills
  • Project Management experience
  • Focus on project management skills. Ideally we are looking for a balance of technical and coordination skills.
 
Day to Day Responsibilities:
  • Author protocol and reports related to analytical methods
  • Coordinate teams and schedules, manage project dashboards
  • Analyze scientific data for regulatory filings
 
Basic Qualifications:
Master’s degree and 1 years of Operations or Scientific experience OR Bachelor’s degree and 3 years of Operations or Scientific experience OR Associate’s degree and 7 years of Operations or Scientific experience
 
Preferred Qualifications:
  • Bachelor's in Biochemistry, Analytical Chemistry, Physical or Life Sciences
  • Strong understanding of methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)
  • Direct experience with method transfer and method validation processes from a Pharmaceutical or Biotechnology Company.
  • Knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing
  • Excellent written and oral communication skills for the timely coordination of scientific results in a fast-paced, multi-disciplinary, team-based environment
  • Demonstrated ability to manage projects cross functionally
  • Demonstrated ability to propose and drive new scientific initiatives 
     
Red Flags:
Only research experience (no industry experience)
Lack of writing experience (only bench work)
Lack of strong experience with coordinating activities in a fast paced environment

 
Interview process:
1/2 hour initial phone/video screen
Second round 1/2 hour with 2-3 team members (video, remote)


We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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