Scientist/Senior Scientist, Drug Product Analytical Development

Moderna

(Cambridge, Massachusetts)
Full Time
Job Posting Details
About Moderna
Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly.
Summary
The role is for a scientist with a strong analytical chemistry background, and experience in the development of novel analytical methods supporting a range of investigational materials. The position will be focused upon method development and establishment for formulated mRNA products and the qualification / validation of these methods. Another aspect of this role will be the transfer of developed methods and monitoring of contract research organizations, including planning and implementing individual projects and defining key deliverables aligned with internal project milestones. This is a predominantly laboratory based role, and the incumbent will be expected to perform experimental work in accordance with industry best practices and external regulatory requirements for method development and validation.
Responsibilities
* Assess emerging analytical technologies and determine their applicability and utility in the assessment of novel mRNA drug products. * Provide analytical chemistry based method development support to formulation development and drug product release, using standard platforms such as HPLC / UPLC, Capillary Electrophoresis and spectrophotometric/ colorimetric endpoints. * Qualify / validate appropriate methodologies per ICH Q2 (R1) requirements for routine use. Oversight and management of outsourced activities at partner CRO’s, to ensure timely generation of high quality data. * Transfer robust analytical methodologies to internal QC groups or external CRO’s. * Provide any routine testing support as needed to enable project progression. * Generate high quality documentation to support regulatory filings.
Ideal Candidate
**Minimum Qualifications** * MS or PhD with a minimum 5 years’ of industry experience in analytical chemistry allied to the characterization of complex formulated biological or small molecule products. * Experience in analytical techniques including spectroscopy (UV, Fluorescence,), separation techniques (UPLC, HPLC, CE) and physicochemical characterization (e.g. DLS, DSC, CD) * Demonstrable evidence of technology transferring established methods to internal or external partners. * Ability to effectively document and communicate results. * Experience in early phase (PhI / PhII) drug development. * Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations. * Knowledge of the regulatory environment, particularly ICH, guidelines on analytical method development and validation and application of USP and Ph. Eur. methods. * Must be independent and able to proactively apply knowledge in the design, execution and qualification of analytical methodologies. **Preferred Qualifications** * Experience in the characterization nucleic acid products (plasmid DNA, RNA, oligonucleotides) * Experience in late phase (PhIII) drug development. * In-depth experience of one or more of the following areas: Mass spectrometry, CD, CGE, IEF, AF4/MALLS, AAA, or DLS. * Previous formal line management, or informal mentoring responsibilities. **Competencies** * Innovative/creative * Problem solving * Outstanding written and verbal communication skills * Excellent documentation skills * Attention to detail * Highly organized * Goal oriented * Adaptability to change * Ability to execute in a fast pace environment * Teamwork

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