Kailera Therapeutics, Inc.
Vice President, Analytical Development and Quality Control
Kailera Therapeutics, Inc., San Diego, California, United States, 92154
Vice President, 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.
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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: Playing a senior leadership role within the Technical Operations organization, the Vice President, Analytical Development and Quality Control position will be accountable for analytical development and QC operations in support of clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical, organizational, and strategic leadership, 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 integrated development plan and program timelines. The individual will also play a critical role in, and participate in, the overall CMC strategy planning and execution. Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities: Serve as Kailera’s most senior subject matter expert on all analytical development and QC activities related to characterization of drug substances and drug products from early to late-stage clinical development through commercialization Maintain current knowledge in analytical 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 laboratories across the globe Be accountable for analytical development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization Author/review/approve relevant CMC sections to enable global regulatory filings Lead cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed Serve as a project core team member and communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making Collaborate with cross-functional line functions (Drug Substance, Drug Product, Supply Chain, Quality, CMC regulatory, CMC Operations, Clinical, and Program Management) to ensure CMC and program goals are met Lead the efforts to assess/identify/engage potential suppliers for analytical development and QC services in support of drug substance and drug product development and manufacturing with adequate risk assessment Travel to CDMOs and other service providers for vendor assessment and qualification, as well as oversight of analytical activities as needed
Required Qualifications: 15 + years of experience in the pharmaceutical/biotech industry with extensive experience in late-phase innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.) Experience with analytical characterization of peptides in sterile formulations and small molecules in oral formulations is required Proven track record of strategic leadership and management with the ability to manage and develop high-performing teams Demonstrated strong project and cross-functional team leadership Thorough understanding and working knowledge of drug development and manufacturing activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements Extensive working experience with management and oversight of the analytical activities at CDMOs and/or stand-alone analytical testing laboratories 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
Education: Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
Additional Information: This position requires travel to domestic and international destinations This position requires working in manufacturing environments where there may be specific gowning or dress code requirements Benefits of Working at Kailera In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families. Comprehensive health benefits and tax-advantaged savings accounts Flexible time off, 13 paid holidays, and a companywide year-end shutdown Monthly wellness stipend Generous401(k) match Disability and life insurance At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience. Salary Range $245,000 - $320,000 USD 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. #LI-Hybrid Create a Job Alert Interested in building your career at Kailera Therapeutics, Inc.? Get future opportunities sent straight to your email. Apply for this job * indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Preferred Name LinkedIn Profile Please confirm your current state of residency * Select... Will you now or in the future require Visa sponsorship? * Select... If you do not currently reside in the Greater Boston or Greater San Diego areas, would you be willing to relocate to one of those areas to be able to work onsite or hybrid 2-3 days/week? Select...
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Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.
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: Playing a senior leadership role within the Technical Operations organization, the Vice President, Analytical Development and Quality Control position will be accountable for analytical development and QC operations in support of clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical, organizational, and strategic leadership, 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 integrated development plan and program timelines. The individual will also play a critical role in, and participate in, the overall CMC strategy planning and execution. Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities: Serve as Kailera’s most senior subject matter expert on all analytical development and QC activities related to characterization of drug substances and drug products from early to late-stage clinical development through commercialization Maintain current knowledge in analytical 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 laboratories across the globe Be accountable for analytical development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization Author/review/approve relevant CMC sections to enable global regulatory filings Lead cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed Serve as a project core team member and communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making Collaborate with cross-functional line functions (Drug Substance, Drug Product, Supply Chain, Quality, CMC regulatory, CMC Operations, Clinical, and Program Management) to ensure CMC and program goals are met Lead the efforts to assess/identify/engage potential suppliers for analytical development and QC services in support of drug substance and drug product development and manufacturing with adequate risk assessment Travel to CDMOs and other service providers for vendor assessment and qualification, as well as oversight of analytical activities as needed
Required Qualifications: 15 + years of experience in the pharmaceutical/biotech industry with extensive experience in late-phase innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.) Experience with analytical characterization of peptides in sterile formulations and small molecules in oral formulations is required Proven track record of strategic leadership and management with the ability to manage and develop high-performing teams Demonstrated strong project and cross-functional team leadership Thorough understanding and working knowledge of drug development and manufacturing activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements Extensive working experience with management and oversight of the analytical activities at CDMOs and/or stand-alone analytical testing laboratories 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
Education: Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
Additional Information: This position requires travel to domestic and international destinations This position requires working in manufacturing environments where there may be specific gowning or dress code requirements Benefits of Working at Kailera In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families. Comprehensive health benefits and tax-advantaged savings accounts Flexible time off, 13 paid holidays, and a companywide year-end shutdown Monthly wellness stipend Generous401(k) match Disability and life insurance At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience. Salary Range $245,000 - $320,000 USD 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. #LI-Hybrid Create a Job Alert Interested in building your career at Kailera Therapeutics, Inc.? Get future opportunities sent straight to your email. Apply for this job * indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Preferred Name LinkedIn Profile Please confirm your current state of residency * Select... Will you now or in the future require Visa sponsorship? * Select... If you do not currently reside in the Greater Boston or Greater San Diego areas, would you be willing to relocate to one of those areas to be able to work onsite or hybrid 2-3 days/week? Select...
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