Scientist, Biopharma Method Transfer – Remote (JP10157)
Boston, MA · Biotech/Pharmaceutical
Job Title: Scientist, Biopharma Method Transfer – Remote (JP10157) Location: Boston, MA. (Remote) Employment Type: Contract Business Unit:Integrated Commercial Attribute Sciences Duration: 12 months with likely extension Posting Date: 4/27/2022
3 Key Consulting is hiring a Scientistfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
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:
Excellent writing skills
Capable of interfacing with multiple digital platforms simultaneously (MS teams, Document control systems)
Knowledge of method transfer and validation in biotech/pharma required
Ability to learn new systems quickly
Day to Day Responsibilities:
Write protocols and reports from templates
Compile and verify data
Statistical analysis of data
Basic Qualifications: Master’s degree and 1 years of Operations or Scientific experience OR Bachelor’s degree and 2 years of Operations or Scientific experience OR Associate’s degree and 7 years of Operations or Scientific experience Preferred Qualifications:
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)
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 documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
Demonstrated ability to critically analyze and interrogate various analytical data sets to drive and influence the process
Demonstrated ability to propose and drive new scientific initiatives
Employee Value Proposition: The person in this role will do all method transfers and validations globally for a leading biotech company.
Lack of biotech/pharm industry experience
Lack of good writing skills
Only research experience
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 firstname.lastname@example.org. 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.