Talent.com
Esta oferta de trabajo no está disponible en tu país.
Associate Director, Drug Product Development and Manufacturing (4 / 10 / 2025)...

Associate Director, Drug Product Development and Manufacturing (4 / 10 / 2025)...

Kailera TherapeuticsLima Metropolitana, Lima, PE
Hace 2 horas
Descripción del trabajo

Overview

Join to apply for the Associate Director, Drug Product Development and Manufacturing role at Kailera Therapeutics.

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.

Responsibilities

The Associate Director, Drug Product Development and Manufacturing will support drug product manufacturing operations including manufacturing process development and optimization, clinical supply manufacturing, and commercial preparedness. The individual will have experience with working and understanding drug product development throughout clinical development, particularly in aseptic fill finish and requires high level of collaboration both with internal teams and external partners. The Associate Director will report to Director, Drug Product Development and Manufacturing.

  • Support the planning and implementation of sterile manufacturing process development, scale-up, technology transfer, and validation efforts in aseptic drug manufacturing at CDMO partners, ensuring strategic alignment and operational excellence
  • Collaborate with cross-functional teams, including drug substance, analytical development, quality assurance, and regulatory affairs to ensure seamless project progression
  • Support continuous improvement initiatives to enhance manufacturing efficiency, reduce costs, enable strategic redundancies, and improve product quality from both technical and strategic sourcing perspectives
  • Contribute to the selection, engagement, and management of CDMOs, including initial vendor assessment and qualification, phase-appropriate technology transfers, process optimization, process validation, and manufacturing oversight
  • Draft technical reports and presentations to communicate results and progress to internal and external stakeholders
  • Support preparation of drug product modules in regulatory dossiers and collaborate with regulatory affairs to support regulatory submissions

Required Qualifications

  • 10+ years experience in the pharmaceutical / biotech industry with a proven track record of technical expertise and leadership in drug product formulation development and manufacturing. Experience with parenteral formulations and drug / device combinations is preferred
  • Demonstrated contribution on project and cross-functional teams
  • Working understanding and experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements in all phases of clinical drug product development and commercial launch
  • Extensive experience with management and oversight of manufacturing activities at CDMOs
  • Experience with drafting of regulatory submissions (IND, NDA, MAA, etc.)
  • Strong problem-solving skills with strategic and sound technically driven decision-making ability
  • Effective written and verbal communication skills and interpersonal skills
  • Innovative team-player with high energy for our dynamic company environment
  • Travel : Up to 20% (domestic and international)
  • Education

  • Bachelors Degree in Pharmaceutical Sciences, Life Sciences, Engineering, or related field
  • 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
  • Generous 401(k) match
  • Disability and life insurance
  • Salary Range

    $160,000—$200,000 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.

    Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Product Management and Marketing
  • #J-18808-Ljbffr

    Crear una alerta de empleo para esta búsqueda

    Director Development • Lima Metropolitana, Lima, PE

    Ofertas relacionadas
    • Oferta promocionada
    Associate Product Manager WM

    Associate Product Manager WM

    ScotiabankLima Metropolitana, Lima, Peru
    Associate Product Manager WM at Scotiabank Peru.Contributes to the execution of the digital strategy of International Wealth Management in the country, executing / developing the vision, construction...Mostrar másÚltima actualización: hace 3 días
    • Oferta promocionada
    • Nueva oferta
    ▷ Quedan 3 Días! Gerente Principal De Diseño Y Desarrollo De Productos...

    ▷ Quedan 3 Días! Gerente Principal De Diseño Y Desarrollo De Productos...

    ScotiabankLima Metropolitana, Lima, PE
    ID de la solicitud : 237087 Gracias por tu interés en ser parte de Scotiabank Perú, apreciamos tu postulación.Estamos en la búsqueda de personas con talento que quieran crecer y lograr los objetivo...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    Associate Director, Drug Product Development and Manufacturing

    Associate Director, Drug Product Development and Manufacturing

    Kailera TherapeuticsLima Metropolitana, Lima, Peru
    Associate Director, Drug Product 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 ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Associate Director or Senior Manager

    Regulatory Affairs Associate Director or Senior Manager

    Dennis PartnersLima Metropolitana, Lima, Peru
    Regulatory Affairs Associate Director or Senior Manager.This biopharmaceutical company is acquiring, developing, and commercializing innovative therapies for patients with rare diseases.They are se...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Director, Virology

    Director, Virology

    CourseLima Metropolitana, Lima, Peru
    Get notified about new Director Of Bioinformatics jobs in.Director Of Bioinformatics Jobs in United States.Senior Director, Head of Protein Sciences and Structural Biology.Director, Data Science - ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Director, Regulatory Affairs (Hybrid)

    Director, Regulatory Affairs (Hybrid)

    Insulet CorporationLima Metropolitana, Lima, Peru
    Director, Regulatory Affairs (Hybrid).This position is integral to Insulet’s global expansion initiatives through the development of Regulatory Strategies, planning and coordination of Internationa...Mostrar másÚltima actualización: hace 29 días
    • Oferta promocionada
    • Nueva oferta
    (Aplicar en 3 Minutos) Associate Director, Drug Product Development and Manufacturing...

    (Aplicar en 3 Minutos) Associate Director, Drug Product Development and Manufacturing...

    Kailera TherapeuticsLima Metropolitana, Lima, PE
    Overview Join to apply for the Associate Director, Drug Product Development and Manufacturing role at Kailera Therapeutics. At Kailera, we are bold, authentic and committed to our mission of develo...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    ▷ Aplicar en 3 Minutos! cGMP Associate Director, Process Development...

    ▷ Aplicar en 3 Minutos! cGMP Associate Director, Process Development...

    USC Rossier Global Executive Ed.D.Lima Metropolitana, Lima, PE
    GMP Associate Director, Process Development Join to apply for the cGMP Associate Director, Process Development role at USC Rossier Global Executive Ed. GMP Associate Director, Process Development ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    • Nueva oferta
    ▷ (3 / 10 / 2025) Import Production Associate Manager...

    ▷ (3 / 10 / 2025) Import Production Associate Manager...

    Fourth FloorLima Metropolitana, Lima, PE
    Overview Our fashion client is seeking a TEMP TO HIRE Import Production, Associate Manager to join their team in Vernon, CA. Responsibilities - Own the end-to-end production lifecycle for assigned...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    Associate Project Director

    Associate Project Director

    MaceLima, Lima, Peru
    The opportunity to join a best-in-class PMO delivering an incredibly important G2G water irrigation and infrastructure project in Peru with international significance, including roads and access, d...Mostrar másÚltima actualización: hace 16 días
    • Oferta promocionada
    Director, Design Quality Assurance (Hybrid)

    Director, Design Quality Assurance (Hybrid)

    Insulet CorporationLima Metropolitana, Lima, Peru
    Director, Design Quality Assurance.Be among the first 25 applicants.Director, Design Quality Assurance.Get AI-powered advice on this job and more exclusive features. The Director, Design Quality Ass...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Associate Director Quality Assurance

    Associate Director Quality Assurance

    BioPhaseLima Metropolitana, Lima, Peru
    The Senior GCP Auditor ensures compliance with SOPs, ICH GCP E6 (R2), FDA regulations, and study protocols.This role supports inspection readiness and collaborates cross-functionally with Clinical ...Mostrar másÚltima actualización: hace 24 días
    • Oferta promocionada
    • Nueva oferta
    Associate Product Manager WM (3 / 10 / 2025)...

    Associate Product Manager WM (3 / 10 / 2025)...

    ScotiabankLima Metropolitana, Lima, PE
    Overview Associate Product Manager WM at Scotiabank Peru.Contributes to the execution of the digital strategy of International Wealth Management in the country, executing / developing the vision, co...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    Regulatory Affairs CMC – Manager / Associate Director / Director

    Regulatory Affairs CMC – Manager / Associate Director / Director

    Discover InternationalLima Metropolitana, Lima, Peru
    Regulatory Affairs CMC – Manager / Associate Director / Director.We are seeking an experienced Regulatory Affairs CMC professional to support regulatory strategy and execution for small molecule develo...Mostrar másÚltima actualización: hace 29 días
    • Oferta promocionada
    Associate PMO Director | Emerging Opportunities Across LATAM (Inicio Inmediato)...

    Associate PMO Director | Emerging Opportunities Across LATAM (Inicio Inmediato)...

    MaceLima, Lima, PE
    Position status : We are growing our team in 2025 and would be interested to speak to experienced candidates with construction and project management experience. Please get in touch if you would like ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    • Nueva oferta
    ▷ Solo Quedan 15h : Vice President Of Products, IgniteTech (Remote) - $400,000 / year USD...

    ▷ Solo Quedan 15h : Vice President Of Products, IgniteTech (Remote) - $400,000 / year USD...

    TrilogyLima Metropolitana, Lima, PE
    Overview Join to apply for the Vice President Of Products, IgniteTech (Remote) - $400,000 / year USD role at Trilogy.This range is provided by Trilogy. Your actual pay will be based on your skills an...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    Associate Director - Stakeholder Management

    Associate Director - Stakeholder Management

    MaceLima, Lima, Peru
    Position Status : This opportunity is for a bid, so it is not yet a secured role.If you would like to be considered as we progress with this position, please click to apply.At Mace, our purpose is t...Mostrar másÚltima actualización: hace 16 días
    • Oferta promocionada
    • Nueva oferta
    ▷ (3 / 10 / 2025) Regulatory Affairs CMC – Manager / Associate Director / Director...

    ▷ (3 / 10 / 2025) Regulatory Affairs CMC – Manager / Associate Director / Director...

    Discover InternationalLima Metropolitana, Lima, PE
    Regulatory Affairs CMC – Manager / Associate Director / Director Position Summary We are seeking an experienced Regulatory Affairs CMC professional to support regulatory strategy and execution for sm...Mostrar másÚltima actualización: hace menos de 1 hora
    Associate Director, Partnerships

    Associate Director, Partnerships

    CollinsonLima, Callao Region, PE
    Quick Apply
    We use our expertise and products to craft customer experiences.Our range of services helps global brand acquire, engage and retain choice-rich customers. Collinson International Limited.Registered ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Director of Quality Control / Beauty-LA

    Director of Quality Control / Beauty-LA

    24 Seven TalentLima Metropolitana, Lima, Peru
    Director of Regulatory Affairs and Quality Assurance- BEAUTY / PERSONAL CARE.Director of Regulatory Affairs and Quality Assurance. This key leadership role is responsible for ensuring that all new and...Mostrar másÚltima actualización: hace 28 días