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location: Cambridge, Massachusetts
job type: Contract
salary: $46.20 - 54.35 per hour
work hours: 9 to 5
The successful candidate will be responsible for process development, formulation, scale up, and process characterization of RNAi products. The candidate will work closely with cross-functional teams and contract manufacturing organizations on drug product development, process transfer and oversight of manufacturing processes.
- Lead formulation development and characterization of CNS DP. This includes literature review, experimental design, execution, data analysis, and report writing.
- Investigate the mechanism of particulate formation and identify the key DP components and the process parameters required for a robust phase II/III CNS DP formulation.
- Support the in-house and external CNS drug product production of non-clinical, developmental and clinical materials
- Manage in-house lab activities for CNS DP
- Participate in cross functional project meetings, provide scientific expertise, and achieve DP deliverables.
- Technical support for optimization of contract manufacturing processes
- Author and review of technical protocols and reports in support of manufacturing process characterization activities
- Author and review quality section of regulatory filings
- Position requires 60% lab work
- PhD degree in chemical engineering, biochemical engineering, or pharmaceutical sciences
- 1+ years of hands-on biopharmaceutical parenteral drug product formulation and drug delivery.
- Demonstrated in-depth understanding of formulation and process of designing experiments and interpreting results.
- Hands-on experience in parenteral drug product formulation, aseptic operation, and process
- Hands-on experience in analytical and chacterization methods for drug products and processes such as, not limited to, UPLC/HPLC, UV/vis spectroscopy, viscosity, density, titration and experience of compendia assays, particulate analysis, including micro flow imaging
- Excellent oral and written communication, and interpersonal skills.
- Proficient using JMP and MS office, including word, visio, excel, presentation, one note.
- Ability to Work Independently
- Demonstrated strong operational execution, organization, and problem-solving skills
- Desire to work in a fast-paced, deadline-driven, results oriented environment
skills: HPLC, Analytical Chemistry, Chemistry
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.