Vice President, Analytical Development and Quality Control [Inicio Inmediato]...

Vice President, Analytical Development and Quality Control

Join to apply for the Vice President, Analytical Development and Quality Control role at Kailera Therapeutics

Vice President, Analytical Development and Quality Control

Join to apply for the Vice President, Analytical Development and Quality Control role at Kailera Therapeutics

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

Playing a senior leadership role within the Technical Operations organization, the Vice President, Analytical Development and Quality Control position will be accountable for analytical development and QC operations in support of clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical, organizational, and strategic leadership, and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the integrated development plan and program timelines. The individual will also play a critical role in, and participate in, the overall CMC strategy planning and execution.

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

Responsibilities

• Serve as Kailera’s most senior subject matter expert on all analytical development and QC activities related to characterization of drug substances and drug products from early to late-stage clinical development through commercialization
• Maintain current knowledge in analytical control strategies supporting a variety of molecule platforms and dosage forms
• Ensure delivery of complex technologies and analytical methods that support Kailera’s product pipeline, including supporting analytical transfers and troubleshooting in laboratories across the globe
• Be accountable for analytical development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND / NDA / MAA), product approvals, and commercialization
• Author / review / approve relevant CMC sections to enable global regulatory filings
• Lead cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan / strategies as needed
• Serve as a project core team member and communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making
• Collaborate with cross-functional line functions (Drug Substance, Drug Product, Supply Chain, Quality, CMC regulatory, CMC Operations, Clinical, and Program Management) to ensure CMC and program goals are met
• Lead the efforts to assess / identify / engage potential suppliers for analytical development and QC services in support of drug substance and drug product development and manufacturing with adequate risk assessment
• Travel to CDMOs and other service providers for vendor assessment and qualification, as well as oversight of analytical activities as needed

Required Qualifications

Education

Additional Information

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

$245,000—$320,000 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.

Seniority level

Executive

Employment type

Full-time

Job function

Business Development and Sales

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