Process Development Scientist-Remote
Posting ID: JP-002659224
This is a 100% remote based role with one of the top 15 biotech companies in the world and a great opportunity for a PD/AD lab professional to work 100% remotely support tech transfers of analytical methods. If interested, please send your resume to email@example.com
Top 3-5 skills:
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
Must have GMP Pharma experience (2-3+ plus years of experience)
* 3+ years of pharma/biotech experience
*Biotech/ pharma experience required)
A 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.
Additional Skills & Qualifications:
Basic Qualifications: Pharma or Biotech
* Masters degree and 3 years of Operations or Scientific experience OR Bachelors degree and 3 years of Operations or Scientific experience
* OR Associates degree and 10 years of Operations or Scientific experience
* OR High school diploma / GED and 12 years of Operations or Scientific experience
* 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
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072