Senior Scientist, Drug Substance Development and Manufacturing

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:

Kailera Therapeutics is seeking a Senior Scientist/Manager Peptide Drug Substance Development and Manufacturing who will support the drug substance manufacturing at CMOs including process development and improvement, clinical supply manufacturing, and commercial preparedness. This position requires an experienced individual with a strong understanding of clinical drug development and requires a high level of collaboration both with internal teams and external partners and CMOs. The Senior Scientist/Manager reports to the Associate Director, Drug Substance Development and Manufacturing. This is a unique and exciting opportunity to work with a well-funded and proven leadership team in a rapidly growing company.

Preferred location: Waltham, MA (on-site or hybrid 2-3 days per week)

Responsibilities:

• Support the planning and implementation of process development, scale-up, technology transfer, and validation efforts in peptide drug substance manufacturing at CDMO partners, ensuring strategic alignment and operational excellence.
• Critically analyze process and analytical data to identify and resolve key challenges during drug substance development/scale-up. Deliver drug substance in a timely and cost-effective manner.
• Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs to ensure seamless project progression
• Draft technical reports and presentations to communicate results and progress to internal and external stakeholders
• Ensure adequate documentation processes and systems are available and followed for drug substance process, testing and release (SOPs / Protocols review /approval).
• Support preparation of drug substance modules in regulatory dossiers and collaborate with regulatory affairs to support regulatory submissions (IND, NDA, etc.)
• Develop a working understanding of industry trends, technological advancements, green manufacturing processes, and regulatory changes to ensure our manufacturing processes are competitive and compliant

Required Qualifications:

• Relevant experience in drug substance development and manufacturing (peptide / small molecule) for clinical-scale supply, process characterization and optimization, technical transfers, and process validation is required
• Solid knowledge of cGMPs, ICH guidelines, Quality systems, and global regulatory requirements.
• Sound skills applying scientific principles to process design, implementation, and tech transfer.
• Strong knowledge of applied analytical methodology relating to in-process controls, drug substance release testing and stability assessment.
• Ability to think critically with a keen sense of urgency, entrepreneurial spirit, and demonstrated problem solving abilities.
• Solution-based critical thinking skills focused on successful execution of drug development plans.
• Ability to ensure accountability of oneself and others.
• Detail-oriented with ability to identify and mitigate risks/issues.
• Ability to contribute to multiple projects simultaneously; assess inter-relationships across multiple disciplines in product development; identify gaps that may impact critical milestones.
• Ability to effectively organize and prioritize tasks to achieve established deadlines.
• Demonstrated ability to contribute to cross-functional teams to advance complex projects to completion.
• Excellent verbal and written communication skills with an ability to build relationships internally and externally.
• Excellent computer skills (e.g. Word, Excel, PowerPoint, SharePoint, Teams).
• Travel: Up to 20% (domestic and international)

Preferred Qualifications:

• Experience with synthesis and manufacturing of peptides is preferred
• Experience with drafting of regulatory submissions (IND, NDA, MAA, etc.)

Education:

Degree in Chemistry, Chemical Engineering, or related life sciences field with a minimum of 5 years relevant drug substance development experience

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.

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