GENERAL SUMMARY OF POSITION:
MassBiologics is seeking a highly motivated scientist to lead the Analytical Development group at MassBiologics’ Vector Manufacturing Center in Fall River, MA. The qualified candidate will participate in development, qualification, and transfer of analytical methods to be used during characterization and release of viral vector products. The Scientist II is also responsible for developing strategies for viral vector formulation. This individual will provide technical leadership in analytical development for cross-functional project teams and CMC teams, establish analytical assay capability will interact with internal teams, including Upstream and Downstream teams in Process Development, Quality Control, Manufacturing, Engineering, QA and Regulatory, as well as CMO clients.
- Lead analytical projects including but not limited to formulation, stability and other related programs
- Develop analytical methodologies and strategies needed to progress products in the pipeline including method development, process support, formulation and stability support, product characterization and method qualifications
- Develop cell-based bioassays for viral vector products
- Revise, review, and author assay standard operating procedures
- Act as subject matter expert in providing analysis and data interpretation both internally and externally
- Develop and transfer qualified assays to QC, and support assay validation and assay trouble shooting
- Provide analytical support in cross-functional project teams, investigation teams and the CMC teams
- Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings
- May lead the investigation and development of biochemical or biophysical assays that will be used in MAb formulation development, stability studies, and in-depth characterization of purified products.
- Maintains substantial knowledge of state-of-the-art principles in antibody purification, formulation and validation.
- Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.
- Performs additional job related duties as required.
- Requires a PhD in a relevant scientific discipline such as Biochemistry, Molecular Biology, Chemical Engineering, or other relevant field and a minimum of 4 years of relevant experience in analytical techniques, protein purification and characterization. Post doctoral experience may serve towards years of experience. Experience in a cGMP environment is preferred.
- Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
- Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
- Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
- Excellent problem solving skills as well as time management and organizational skills.
- Capabilities to manage others, assign and schedule work, and conduct performance evaluations.
- Occasional travel is required.
- Willingness to work extended and, at times unusual hours to meet business needs.
Experience in one or more of the following areas is required:
- Solid knowledge in the principles of biochemical and biophysical analytical techniques for protein and viral vector characterization, such as qPCR, SDS-PAGE, HPLC, western blotting, IEF, ELISA, differential scanning calorimetry (DSC), and dynamic light scattering (DLS).