Director Analytical Development and Quality Control

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, Analytical Development and QC will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise 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 company’s integrated development plans and program timelines.

Responsibilities

• Serve as a subject matter expert on analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization.
• Maintain current knowledge in analytical methods and 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 CDMO laboratories.
• Provide input for developing and implementing analytical development strategies, including overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
• Review authoring of relevant CMC sections to enable global regulatory filings.
• Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed.
• Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making.
• Collaborate with cross-functional line functions to ensure CMC and program goals are met.
• Support efforts to assess / identify potential suppliers for analytical development and QC activities in support of drug substance and drug product development and manufacturing with adequate risk assessment.
• Travel to CDMOs and other service providers as needed for vendor assessment and qualification, technology transfers, and analytical activities oversight.

Qualifications:

• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.
• 7+ years of experience in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.).
• Demonstrated strong project and cross-functional team participation.
• Working knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements.
• Working experience with management and oversight of the analytical activities at CDMOs and/or CTLs.
• Strong problem-solving skills with strategic and sound technically driven decision-making ability.
• Effective written and verbal communication and interpersonal skills.
• Innovative team-player with high energy for our dynamic company environment.

Additional Information:

• This position requires some travel to domestic and international destinations.

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:

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