Process Engineer Ii/Sr. Process Engineer I

Reporting to the Director, Internal Downstream Development & Mfg, the Engineer/Senior Engineer, Internal Downstream Development & Manufacturing will support purification at pilot scale clinical manufacturing and development scale for products within the Kiniksa pipeline. The candidate should have purification experience, 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.

Responsibilities (including, but not limited to):

• Hands on support and execution for downstream purification steps such as column chromatography, harvest clarification, TFF and normal flow filtration

• 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

• Assist lab scale experiments and senior engineering staff

• Work closely with vendors and service providers to enable early phase clinical material production within Kiniksa's CMC laboratory

Qualifications:

• BS 3-6+ years or Master's degree with 1+ years in Life Sciences/Chemical Engineering

• Relevant biological process development and manufacturing experience with a strong record of achievement

• Experience in purifying proteins, operating large-scale purification systems

• General understanding of theoretical and practical protein separation techniques including IEX, HIC, affinity, and multimodal chromatography

• Fundamental understanding of protein chemistry and bioprocess engineering practices

• Relevant biological process development and manufacturing experience

• Experience in a GMP regulated environment and an understanding of regulatory/quality requirements for clinical stage manufacturing

• Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity

• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement

• Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost targets

• Strong commitment to compliance and ethical standards

• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

• This position does not require travel

• Salary is commensurate with experience

• Kiniksa Benefits Summary - USA

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.