What You’ll Do:

This Senior Scientist will support ongoing activities for drug product formulation and manufacturing with external partners and CDMOs. This would include manufacturing process development and optimization, clinical supply manufacture, and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development through all stages of clinical development.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• 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)

Preferred Qualifications:

• 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

What You’ll Do:

The candidate selected for Director, Drug Product Manufacturing and Development will oversee drug product manufacture from the clinical stage through the commercial stage for Kailera’s pipeline compounds. This role will have high-visibility and will be responsible for providing technical oversight of late-stage process development activities, ensuring the necessary framework is in place for the manufacture of robust aseptic drug products at the commercial scale. The selected individual will work closely with cross-functional teams across Kailera and external manufacturing partners to develop late-stage strategies for process scale-up, with a focus on commercial readiness.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Develop and design strategies for all aspects of late-stage process development, scale-up, optimization, and commercial readiness initiatives for aseptic drug products manufactured by external manufacturing partners
• Implement initiatives to enhance manufacturing efficiency, ensure robustness, mitigate risks, reduce costs, and improve product quality through experimental design, providing technical expertise, and program leadership
• Coordinate drug product campaign activities with leads from cross-functional groups across the Kailera organization to ensure seamless progression of timelines, updating the broader program team with regular updates
• Provide technical expertise for process performance qualification campaigns, ensuring that materials, equipment, and process controls consistently produce high-quality sterile drug products
• As necessary, act as Kailera’s person-in-plant for process development, engineering, and cGMP activities critical to program success
• Support authoring, review, and approval of SOPs, batch records, change controls, deviations, OOS/OOT investigations, CAPAs, and campaign summary reports
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND/IMPD, NDA and BLA)
• Provide scientific input and expertise to drug product activities related to life-cycle management initiatives for sterile drug products

Required Qualifications:

• 10+ years’ experience in the pharmaceutical/biotech industry with a proven track record of technical expertise and leadership in aseptic manufacture of sterile drug products
• Extensive experience in the oversight of aseptic process development unit operations and equipment used for late-stage filling of vials, pre-filled syringes, and cartridges
• Working knowledge and experience in aseptic drug product development and manufacturing with respect to cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
• Demonstrated contribution to project and cross-functional teams
• Strong problem-solving skills with strategic and sound technically driven decision-making ability
• Effective interpersonal, written, and verbal communication skills
• Innovative team-player with high energy for Kailera’s fast-paced company environment

Preferred Qualifications:

• Prior experience in supporting the scale-up and commercialization of aseptic drug products, including process validation

Education:

• Bachelor of Science degree in Pharmaceutical Sciences, Life Sciences, Engineering, or related field. Advanced degree preferred

What You’ll Do:

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization
• Build and execute project plans with clearly defined risks and milestones
• Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements
• Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements
• Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
• Drive design verification and validation activities, including test method development, protocol execution, and documentation
• Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
• Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
• Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities
• Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
• Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing
• Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File
• Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366

Required Qualifications:

• Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role
• Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions
• Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
• Strong knowledge of applicable regulatory standards and guidance documents
• Excellent communication, leadership, and cross-functional collaboration skills

Preferred Qualifications:

• Experience working in a regulated pharmaceutical or biotech environment
• Familiarity with combination product regulations (21 CFR Part 4)
• Experience with supplier management of external development, testing, and manufacturing partners
• PMP certification or formal project management training is a plus

Education:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.