Associate Director, Analytical Development and Quality Control

Responsibilities

• Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
• Support analytical development and QC activities related to characterization of peptide 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
• Support development of analytical methods that support Kailera's product pipeline, including analytical transfers and troubleshooting in CDMO laboratories
• Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization
• Support 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
• Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight
• Required Qualifications:
• A bachelor's degree and 10+ 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.)
• Or an advanced degree with 5+ years
• Knowledge of peptide chemistry is required
• Demonstrated project and cross-functional team participation
• Experience in authoring regulatory documents
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Experience with oversight of the analytical activities at CDMOs and/or CTLs
• Sound problem-solving skills with technically driven decision-making ability
• Effective written and verbal communication and interpersonal skills
• Innovative team-player with high energy for our dynamic company environment

Requirements

• Knowledge and experience in analytical development of peptide therapeutics (DS and DP)
• Knowledge and experience in analytical development of injectable products, and associated control strategies
• Education:
• A Bachelors degree with 10+ years or an advanced degree with 5+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.
• Additional Information:
• This position requires some travel to domestic and international destinations
• This position requires working in environments where there may be specific gowning or dress code requirements
• Salary Range
• $155,000 - $190,000 USD
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Benefits

Additional Information

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.

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