Senior Scientist, Analytical Development

COMPANY BACKGROUND:

Werewolf Therapeutics is an exciting, newly public, biotherapeutics company located in the heart of the Watertown biotech hub, focusing on the development of novel biologic agents targeting immune regulatory pathways for the treatment of cancer.

POSITION SUMMARY

As a key member of the CMC function this position will primarily be responsible for the development, qualification, and execution of analytical methods and bioassays in support of clinical development of Werewolf’s recombinant protein therapeutics.  Analytical techniques involved include, but not limited to, HPLC- and Capillary Electrophoresis-based separation techniques, ELISA, and cell-based bioassay. The Scientist will utilize a combination of these analytical techniques to characterize complex recombinant proteins.  This role will be working in a high collaborative team and providing support for Process Development and Research and Discovery groups.  In addition, this role is also expected to provide technical guidance and training to junior members of the team.

ESSENTIAL FUNCTIONS

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• Develop analytical methods including protein titer, SEC, IEX, CE-SDS, cIEF, peptide maps, glycan maps and bioassays such as ELISA and cell-based potency assay for highly engineered recombinant proteins. Author analytical protocols and development reports for in-house analytical activities.
• Contribute to analytical method transfer to and from external testing labs (CROs or CMOs) by performing method qualification, troubleshooting, or providing technical guidance. Review and approve protocols, reports and testing results generated by external labs.
• Work collaboratively with internal Research and Discovery group and Process Development group to enhance the understanding of Werewolf’s pipeline molecules. Plan and execute tasks such as manufacturability assessment, in-process analysis, formulation screening, and product variant/impurity characterization.
• Plan and maintain laboratory daily functions. Coordinate installation and preventive maintenance of lab equipment. Ensure lab equipment is calibrated and maintained in proper working order. Perform basic equipment troubleshooting and repairs. Maintain a clean and safe working environment.

POSITION QUALIFICATIONS

Education:    

• BS/MS (with 5+ years relevant experience) or PhD (wtih 2+ years’ experience) in Analytical Chemistry, Biochemistry or related fields.

Experience and Requirements:  

• Biotech or biopharmaceutical industry experience; experience with start-ups is highly desired.
• Familiar with principles of analytical and bioassay techniques listed under Essential Functions.
• Hands-on experience with common brands of analytical equipment and developing protein analytical methods for use in a GMP setting. Cross-function working experience with process development or manufacturing is highly desired.
• Experience with managing flow of samples and turning around high-quality testing results in a timely manner.
• Familiar with ICH, USP and EP guidelines for biopharmaceutic development and analytical development.
• Excellent communication (both written and verbal), analytical, problem-solving, and organizational skills are required.

Computer Skills: 

• Microsoft Office proficiency.
• Familiar with basic data processing, analysis, and visualization software.

Other Requirements:

• Good working knowledge of current Good Manufacturing Practices (cGMPs) is highly desired.
• Science-based critical thinking.
• Ability to multitask and adapt prioritization based on project needs.
• Lab management experience is highly desired.

WORKING CONDITIONS AND PHYSICAL EFFORT

• Work is normally performed in a typical interior/office/lab work environment.
• None or very limited physical effort required.