Planet Pharma · 6 hours ago
Scientist II
Planet Pharma is a company seeking a driven and talented Scientist to join their Functional Method Development & Transfer (MDT) group. The role involves designing and executing experiments for product/process optimization and ensuring successful technology transfer into a GMP manufacturing environment.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Conduct laboratory work; following written protocols; execute test methods as assigned
Help to establish process or quality control (QC) method requirements to meet product specifications
Collaborate and guide new product introduction teams throughout the stages of product development process (PDP) in order to: Act as a liaison between development and manufacturing teams
Participate in the construct and execution of controlled experiments (including DOEs, gauge R&R studies) to develop/optimize manufacturing ready production workflows or test methods
Participate in the construct and execution of qualification and validation experiments
Monitor, trend and analyze results from development and pilot lots during the NPI process; track off-targeted production outputs, troubleshoot/perform root cause analysis, and make technical and compliance related recommendations as required
Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on results
Participate or author technical documents, such as plans/protocols, engineering reports, SOPs, or other manufacturing related documentation
Participate in software and instrument validation for NPI transfer into Reagent QC
Qualification
Required
B.S./M.S./ PhD in Biochemistry, Chemistry, Biological Sciences, Physical Chemistry or equivalent disciplines with 3+ years of experience in the pharma, biotech or medical device industry
Molecular biology bench experience
Next-Generation Sequencing experience
GMP experience
Good Documentation Practice
Lab Management
Microsoft Word
Detail Oriented
Excel
Presentation Skills
Strong interpersonal, verbal and written skills
Preferred
Equipment Maintenance
Equipment Onboarding
Library Prep
Stability testing
Statistical Analysis
Test Method Validation
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Company data provided by crunchbase