Sr Process Engineer I, Downstream Dev & Mfg

Senior Process Engineer I, Downstream Development and Manufacturing

Reporting to the Director, Internal Downstream Development Manufacturing, the individual will support / lead purification process development of monoclonal antibodies, primarily, and pilot scale clinical manufacturing both in our internal phase 1 / 2 GMP facility and with our external CDMOs. In addition, the individual will support technology transfer to and from external partners, process scale-up, viral clearance studies, and clinical manufacturing planning and execution. The candidate must have experience at both process development and pilot scales, experience with monoclonal antibody (mAbs) development and purification strategies, have familiarity with disposable technologies, and possess a general understanding of compliance for early-stage clinical production. The candidate must be highly motivated, science driven, and results oriented in a team environment.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. This schedule is subject change and may require 5 days in the office from time to time.

Responsibilities :

• Provide hands-on leadership in the laboratory, designing and executing laboratory experiments, leading analysis and documentation, and leading lab activities to develop a downstream process that is robust, scalable, and suitable for cGMP production.
• Perform pilot scale purification runs to support new product development, material supply needs, and demonstration runs for multiple programs spanning all phases of biopharmaceutical development.
• Provide support for technical transfer activities, including facility fit, gap, and risk assessments, as well as provide technical support as SME for implementation of purification processes at pilot and clinical scale.
• Contribute to the growth of the manufacturing team and assist in the development of the internal / external manufacturing and supply network. Ability to provide direction and guidance to junior team members.
• Work closely with vendors and service providers to enable early phase clinical material production within Kiniksa's CMC laboratory.
• Develop, optimize, and characterize downstream purification steps such as column chromatography, harvest clarification, TFF and normal flow filtration.
• Evaluate innovative technologies / equipment to reduce COG's and streamline process development and manufacturing.
• Perform lab studies to support root cause analysis and provide technical assessments for deviations.
• Author technical reports, technology transfer packages and presentations.
• Collaborate closely with QA to develop operating procedures and control strategies suitable for early phase clinical manufacturing.
• Provide leadership support / guidance to CMC teams and subject matter expertise as needed for global regulatory filings.

Qualifications :

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.