Senior Scientist, Process Development

COMPANY BACKGROUND:

Werewolf Therapeutics is an exciting, newly-public, biotherapeutics company located in the heart of the Boston/Cambridge biotech hub, focusing on the development of novel biologic agents targeting immune regulatory pathways for the treatment of cancer. (PLEASE NOTE WE ARE RELOCATING TO WATERTOWN, MA BY MAY, 2022)

POSITION SUMMARY

As a key member of the CMC function this position will primarily be responsible for the development, optimization, and troubleshooting of upstream and/or downstream processes in support of clinical development of Werewolf’s recombinant protein therapeutics.  Upstream process development activities include, but are not limited to, shake-flask and bench scale bioreactor material generation, parameter screening, and evaluation of growth and product quality performance. Downstream process development activities include, but are not limited to, chromatography resin screening, buffer optimization, filtration optimization, and characterization of in-process purity and performance. The Scientist will utilize a combination of these techniques build robust processes and deepen process and product understanding. This position is primarily hands-on experimentation in a laboratory setting. This role will be working in a high collaborative team, providing support to Research and CMC 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.

• Upstream: Develop scalable mammalian cell culture processes for the production of recombinant therapeutic protein molecules. Screen and optimize process parameters at the shake flask and bench scale bioreactor stages to improve titer and product quality profile. Generate representative protein pools for further downstream development and analytical characterization. Apply statistical analysis and experimental design to evaluate key process parameters. Author process development reports and tech transfer documents to build process knowledge.
• Downstream: Develop scalable downstream unit operations including chromatography and filtration, as well as robust integrated downstream purification processes. Screen chromatography resins, buffers, and operating parameters. Evaluate and select process filters. Generate representative purified protein as well as in-process fractions or isolates for further analytical characterization. Contribute to process transfers to and from external CMOs through authoring of tech transfer documents, process troubleshooting, or providing technical guidance.
• Work collaboratively with the internal Research and Discovery group and analytical group to enhance the understanding of Werewolf’s pipeline molecules. Plan and execute tasks such as manufacturability assessment, in-process analysis, buffer screening, and product variant/impurity tracking.
• 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.
• Other duties as may be required.

POSITION QUALIFICATIONS

Education:  

• BS/MS (with 5+ years relevant experience) or PhD (with 2+ years experience) in Chemical Engineering, Protein Chemistry, Biochemistry or related fields.

Experience and Requirements:  

• Biotech or biopharmaceutical industry experience; experience with start-ups is highly desired.
• Hands on experience with biopharmaceutical unit operations, including at a minimum:
• For upstream: mammalian cell culture technique, aseptic technique, measurement of growth, titer, metabolites, seed trains, and stirred-tank bioreactors.
• For Downstream: Akta Chromatography skids, depth filtration, tangential flow filtration, viral filtration.
• Additional areas of experience that are considered desirable: familiarity with scale-up and transfer to GMP manufacturing; familiarity with running process analytics, including SDS-page, HPLC/UPLC, ce-SDS, or Elisa; familiarity with current Good Manufacturing Practices (cGMP) for biologics.
• 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.
• Additional skills considered desirable: design of experiments, statistical analysis.

Other Requirements:

• Ability to multitask and adapt prioritization based on project needs.
• Lab management experience is highly desired.

WORKING CONDITIONS AND PHYSICAL EFFORT

• This position primarily involves hands-on laboratory work, involving proximity to chemical or physical hazards, requiring basic safety precautions to be followed.
• Occasional lifting of laboratory equipment or supplies of up to 40 lbs. is expected.
• Outside of the lab, work is performed in a typical interior/office environment.