Director, Device Engineering

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You'll Do :

The Director, Device Engineering will work within the Technical Operations group and collaborate with external vendors to ensure that selected devices for the delivery of drug from pre-filled syringes and cartridges are suitable for their intended use as combination products. The Associate Director / Director will report to the Senior Director, Drug Product Development and Manufacturing.

Preferred location : Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities :

• Oversee all aspects of the development of drug delivery devices and combination products, including single-use autoinjectors containing pre-filled syringes and multi-use pens containing cartridges
• Act as the primary liaison between Kailera and external vendors responsible for developing devices to deliver a broad range of subcutaneous drug doses
• Collaborate between cross-functional groups within Kailera and external vendors to define device requirements, execute the necessary development activities and demonstrate their suitability
• Collect user requirements, communicate product specifications and translate into approved technical studies and assessments for external vendors, as necessary, for characterization, qualification and validation.
• Provide engineering oversight, program guidance and device expertise to external vendors performing design, engineering and validation to ensure that device needs are met for a broad range of applications within pre-defined timelines
• Review and approve development, qualification and validation plans for external vendors to ensure clinical and ultimately commercial readiness
• Ensure appropriate regulations are followed to ensure a seamless transition from the clinical stage to commercialization, interacting with worldwide regulatory agencies as necessary

Required Qualifications :

Education :

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range

175,000-$230,000 USD

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION :

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify :

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

LI-Hybrid

Salary : $175,000 - $230,000