Scientist, Analytical Development
- Employer
- Commonwealth Sciences, Inc.
- Location
- Boston, MA
- Closing date
- Jun 24, 2022
View more
- Sector
- Science, Pharmaceutical, Laboratory
- Organization Type
- Corporate
You need to sign in or create an account to save a job.
Position located in Waltham, MA
Responsibilities of the Scientist, Analytical Development:
Requirements of the Scientist, Analytical Development:
Responsibilities of the Scientist, Analytical Development:
- Lead method validation/qualification activities, authoring and/or reviewing protocols, and coordinating testing with Contract Research Organizations (CROs).
- Lead the stability program and provide timely stability updates for regulatory documents.
- Generate standard operating procedures for the characterization of biologics.
- This role will also train lab members and manage the transfer of methods to
- Contract Manufacturing Organizations (CMOs).
- Identify and stay current with new analytical technologies and methods for the characterization of biologics.
- Perform characterization and degradation studies on lead candidates, critically assess findings and share results with cross-functional teams.
- Manage timelines and milestones for analytical assessment of lead candidates and ensure a smooth transfer to CMOs and Contract Test Organizations (CTOs).
- Provide subject matter expertise support in determining the proper fit for Contract Test
- Organizations (CTOs) for assay transfer, develop protocols or assay qualification and validation, and review and approve data.
- Prepare presentations for external partners and internal meetings and represent analytical and CMC issues.
- Provide analytical support for investigations at CTOs and CMOs, generate hypothesis, critically review results to support deviations, Out Of Specification (OOS) results,
- Corrective And Preventative Actions (CAPAs).
- Review analytical development reports, assay and process validation reports and other technical documents for technical correctness and regulatory compliance.
- Travel to CTO sites may be required as needed to assist with site audits (up to 5% travel).
- Other duties and responsibilities as required by departmental and business needs.
Requirements of the Scientist, Analytical Development:
- A PhD degree in analytical chemistry, biochemistry or a related analytical scientific discipline with 1-5 years of experience, a BS with 7 years or an MS with 5 years' experience.
- Hands-on experience with some of the following analytical methods: ELISAs, cell-based potency assays, HPLC, UPLC, CE-SDS, SDS-Page, protein purification, CEX, icIEF, and Mass
- Spectrometry.
- Experience with statistical and analytical software, such as SPSS, JMP, Excel,and SAS
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert