Scientist - Formulation & Fill Finish - Contract-to-Hire

COMPANY:

Leading genome editing company

LOCATION:

Cambridge, MA

TITLE:

Scientist, Formulation & Fill Finish - Contract-to-Hire

RELOCATION ASSISTANCE:

Not available.

ROLE RESPONSIBILITIES:

This individual will serve as the SME for AAV Formulation and Fill Finish process development and on particulate control and visual inspection processes across fill finish operations. This person will collaborate with CMOs to support formulation and fill finish activities during process development, preclinical, clinical and potentially commercial manufacturing. Other responsibilities include:

• Support scale-up/scale-down of drug product manufacturing e.g. fill finish, freeze thaw, lyophilization
• Design studies for AAV formulation and fill finish process development, characterization, qualification, validation to ensure long-term stability of bulk and vialed drug product
• Lead formulation and fill finish activity support for technology transfers, formulation and fill finish process deviations/investigations by designing and executing appropriate studies at CMO
• Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes
• Implement screening, sizing, implementation, and phase-appropriate validation activities for sterilizing grade liquid filters in support of fill finish activities
• Independently design and execute experiments (DOE) to generate optimal and robust formulation and fill finish process
• Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to formulation and fill finish processes

CANDIDATE REQUIREMENTS:

• MS or PhD degree in a relevant field.
• In depth understanding and hand on experience in the following areas is required: particle size analysis, visual inspection, sterile filtration, formulation, fill finish process development
• Familiar with current varieties and suppliers of parenteral vials and stoppers
• Experience working with filter membrane manufacturers on the design filter validation studies
• Fundamental understanding of formulation and fill finish process development, qualification, validation and transfer
• Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization/validation and technology transfer
• Proven project management skills
• Strong communication skills
• Excellent analytical thinking and problem-solving skills
• Knowledge of statistical methods for DOE design and data analysis (e.g. JMP), experience with Quality by Design (QbD) is preferred

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.