Senior Scientist, Drug Product Manufacturing and Development

Responsibilities

• Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
• Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies, acting as Kailera's person-in-plant for activities critical to program success
• Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
• Review master batch records and executed batch records to ensure product quality
• Author change controls, review specifications, change notifications, and manage manufacturing deviations as necessary, working closely with Kailera's quality group
• Present formulation development and manufacturing updates to internal and external stakeholders periodically
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD, and NDA)
• Required Qualifications:
• 5+ years of experience in solid-oral dosage form development. Technical expertise in unit operations common to solid oral dosage form (e.g., milling, wet/dry granulation, compression, and film-coating)
• Extensive experience with management of day-to-day activities at CDMO's
• Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
• Strong working knowledge of Microsoft suites and common scientific software
• Experience with design of experiment (JMP/Minitab)
• Experience using quality systems such as Veeva to author and approve documents
• Excellent verbal, written, and interpersonal skills
• Ability to travel up to 10-20% (domestic and international)

Requirements

• Experience in the GLP-1 space, late-stage development
• Education:
• B.S. and 12+ years of experience, advanced degree with 10+ years, or a PhD with 5-8 years of experience
• Degree in Engineering, Pharmaceutical Sciences, Chemistry or closely related field
• Salary Range
• $143,000 - $175,000 USD
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
• E-Verify:
• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
• #LI-Hybrid

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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