Senior Manager, CMC Operations Job at Kailera Therapeutics (Waltham)

Director, Business Excellence & Portfolio Operations

The Director is responsible for advancing operational excellence across Process ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 15 years of project/portfolio management, engineering, and/or life sciences experience
Master’s degree & 18 years of project/portfolio management, engineering, and/or life sciences experience
Bachelor’s degree & 20 years of project/portfolio management, engineering, and/or life sciences experience
10 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience in Operations Drug Development (Process Development, Tech Operations, CMC, etc.)
Experience in project and portfolio management in the pharmaceutical, contract manufacturing or biotech industry
Strategic experience to support optimization of timelines and resources within budget
Technical understanding of biopharmaceutical and small molecule pharmaceutical product and process development, manufacturing, quality and supply chain
Strong knowledge and willingness to learn digital and planning tools. Ability to connect digital technology to impact Operations and Process Development core business processes. Experience with Planisware
Experience driving process improvements through operations excellence and continuous improvement ways of thinking (i.e. six sigma, kaizen principles)

Job Responsibility

Lead and develop a high-performing team including supporting development of key talent, serving as a mentor, and strengthening organizational capability in portfolio management, operational excellence, and digital enablement
Ensure full integration and alignment with functional leads and Product Delivery Teams across regions
Enable effective program and portfolio execution by providing support to key stakeholders and Product Delivery Teams to effectively track integrated plans, key milestones, and insights in an aligned and transparent manner
Drive resource planning and operational efficiency by advancing tools and identifying solutions to support scenario assessments of resource capacity across the portfolio
Establish scalable processes and tools that improve planning, forecasting, and visibility into team capacity
Advance and champion digital transformation and process improvement efforts by partnering with stakeholders in Process Development and Operations to Identify opportunities to improve ways of working and partnering to integrate solutions into business processes
Work in Planisware, MS Project, Excel, PowerPoint, SmartSheets, and MS Teams

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

New

Senior Manager, Logistics Operations

This individual contributor role will be responsible for driving the performance...

Location

Poland , Warsaw

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

BS/BA degree in Supply Chain/Logistics, Engineering, or Business Administration
8–10 years (BS) or 5–8 years (MS) of experience in Distribution/Logistics/Supply Chain, ideally in the pharma or biotech sector
Experience in a cGMP and cGDP-regulated environment with a strong understanding of pharma logistics
Hands-on experience with SAP or ERP systems and advanced logistics software (TMS, WMS, visibility tools)
Working knowledge of GDP and regulatory frameworks
Strong organizational skills with the ability to manage multiple projects in a fast-paced environment
Demonstrate a strong and independent work ethic that sees tasks to completion
You drive for results and demonstrate the ability to develop solutions
Outstanding communication skills (verbal and written) to effectively collaborate and communicate with senior CMC Management in a dynamic, cross-functional matrix environment
Ability to manage multiple projects in a fast-paced environment

Job Responsibility

Execute daily operations of Moderna’s European logistics hub, managing upstream transportation (air, road, sea) and warehousing
Ensure efficient material flows across inbound, intercompany, warehousing, and outbound supply chain segments
Lead implementation of GDP-compliant shipping processes including handling, validation, and customs
Drive operational excellence across all logistics flows, maintaining alignment with Health Authority, GDP, GMP, Cold Chain, Trade, and Security requirements
Partner with cross-functional stakeholders to align compliance and operational priorities
Deploy automation and digital platforms in partnership with Moderna Digital and Logistics Engineering
Lead integration with 3PLs and carriers, ensuring real-time data connectivity and performance alignment
Optimize cost-to-serve models while preserving reliability and compliance standards
Collaborate with Trade Compliance to ensure import/export readiness and customs adherence
Develop and maintain logistics SOPs, compliance documentation, and performance dashboards

What we offer

Best-in-class healthcare, plus voluntary benefit programs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

Fulltime

Senior Global CMC Manager (Development & Lifecycle)

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences
Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products
Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes
Extensive experience in variation management, including the development and execution of regulatory and CMC strategies
Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage
Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products
Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance
Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models
Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners
Experience interacting with regulatory authorities and maintaining effective professional relationships

Job Responsibility

Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes
Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products
Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals
Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements
Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems
Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures
Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products
Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes
Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities
Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Director / Senior Director, Global Logistics, Warehousing and Trade Compliance

The Senior Director, Global Logistics, Warehousing and Trade Compliance is respo...

Location

United States , Cambridge, MA / Durham, NC

Salary:

210000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Supply Chain, Engineering, Life Sciences, or related field
MBA or Master’s degree preferred
18+ years of progressive experience in global logistics, warehousing, supply chain, and/or trade compliance within biotech, pharmaceutical, or other highly regulated environments
Proven senior leadership experience managing complex global networks of internal operations and external partners (CMOs, CDMOs, 3PLs)
Working knowledge of global trade compliance regulations, including U.S. Customs and relevant international authorities
experience with permits, licenses, duties, VAT, sanctions, and duty savings strategies
Demonstrated expertise in pharmaceutical cold chain logistics (ambient, refrigerated, frozen, ultra-low temperature) across R&D, clinical, and commercial programs
Strong strategic and operational leadership skills, with the ability to influence cross-functional and matrixed stakeholders globally
Excellent analytical, communication, and decision-making skills in high-complexity environments
Financial acumen including budgeting, cost control, and KPI management

Job Responsibility

Global Logistics: Provides operational and strategic leadership for all R&D, Clinical, and Commercial shipments
Serves as subject matter expert for ambient, low‑temperature, and ultra‑low‑temperature cold chain systems, including shipping systems qualification and lane validation, in support of CMC development and commercialization
Supports Commercial Patient Operations for Risto-cel Patient shipments
Warehousing: Leads internal warehouse operations and the global 3PL network supporting storage, inventory management, kitting, and production support for critical raw materials, drug substance, and drug product
Ensures inventory accuracy, material availability, and scalable warehouse capabilities aligned with clinical and commercial demand
Trade Compliance: Acts as the enterprise risk leader for global trade compliance, ensuring compliance with international, federal, and state import/export laws and regulations
Leads the development and governance of compliant, efficient trade processes across North America, Europe, and Asia‑Pacific regions, and serves as the primary interface with customs brokers, government agencies, and external auditors
Champions a culture of compliance while enabling business agility and uninterrupted supply
Supports Market Access team for any commercial trade or channel distribution aspects
Strategy & Leadership: Develop and execute global logistics, warehousing, and trade compliance strategy to support R&D, clinical trials, and commercial operations

Fulltime

New

Senior Manager, Logistics Operations

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

Spain , Madrid

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

BS/BA degree in Supply Chain/Logistics, Engineering, or Business Administration
8–10 years (BS) or 5–8 years (MS) of experience in Distribution/Logistics/Supply Chain, ideally in the pharma or biotech sector
Experience in a cGMP and cGDP-regulated environment with a strong understanding of pharma logistics
Hands-on experience with SAP or ERP systems and advanced logistics software (TMS, WMS, visibility tools)
Working knowledge of GDP and regulatory frameworks
Strong organizational skills with the ability to manage multiple projects in a fast-paced environment
Demonstrate a strong and independent work ethic that sees tasks to completion
You drive for results and demonstrate the ability to develop solutions
Outstanding communication skills (verbal and written) to effectively collaborate and communicate with senior CMC Management in a dynamic, cross-functional matrix environment
Ability to manage multiple projects in a fast-paced environment

Job Responsibility

Lead day-to-day logistics hub operations for upstream warehousing and all modes of transportation (air, road, sea)
Oversee end-to-end material flow across inbound, intercompany, warehousing, and outbound lanes within the European upstream supply chain
Ensure regulatory adherence to GDP, GMP, Cold Chain, Trade, and Security compliance across all logistics operations
Implement validated shipping processes from goods handling and packaging to customs clearance and shipping documentation
Own and optimize Moderna’s cost-to-serve metrics while maintaining high service reliability and compliance standards
Collaborate closely with Quality, Digital, Planning, and Commercial Supply Chain to ensure logistics processes meet business and compliance requirements
Drive automation and next-generation logistics technologies in partnership with Moderna Digital and Logistics Engineering
Deploy and maintain Transport Management Systems (TMS), Warehouse Management Systems (WMS), and real-time visibility platforms
Integrate AI/ML tools for forecasting, exception management, and digital twins to enable predictive, proactive logistics control
Implement IoT-based cold chain monitoring systems and smart dataloggers to enhance temperature-sensitive product management

What we offer

Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

Fulltime

Senior Director, Manufacturing, Science & Technology

As a Senior Director, Manufacturing, Science & Technology, you will lead a high-...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

PhD in Chemistry, Biochemical Engineering, or a related scientific discipline
Extensive experience in pharmaceutical or biotechnology manufacturing, with deep expertise in process development for both small and large molecules
Proven knowledge in sterile processing, fill-finish operations, and packaging
Strong understanding of CMC requirements and regulatory dossier submissions (EMA, FDA)
Inspirational leadership with a hands-on approach to managing technical operations, complex projects, and cross-functional teams
Exceptional analytical, scientific, and communication skills, with the ability to convey complex concepts to diverse stakeholders
Fluency in English is essential
Willingness to travel internationally as required

Job Responsibility

Provide strategic direction and technical oversight for all external manufacturing activities
Lead and oversee the execution of technology transfers, validation programs, and lifecycle management for both new and existing products
Establish and monitor performance metrics, proactively manage risks, and make data-driven decisions aligned with business objectives
Ensure robust technical evaluations for material changes, process scale adjustments, and cost-efficiency initiatives
Contribute to vendor qualification, audit processes, and long-term capacity and supply planning
Ensure full compliance with cGMP regulations and internal quality standards across all operations
Lead and manage a team of pharmaceutical technical and scientific experts
Serve as the primary technical liaison with CMOs, ensuring alignment with strategic goals and regulatory expectations

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

Regulatory Project Manager

At GSK, we’re constantly developing new products and improving our established m...

Location

Poland , Poznan; Warsaw

Salary:

236250.00 - 393750.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

Job Responsibility

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

What we offer

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Fulltime

Clinical Trials Regulatory Submission Senior Associate

In this vital role you will be responsible for performing Regulatory submissions...

Location

Argentina , Buenos Aires

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 5 years of Clinical Trials experience
Minimum 3 years of regulatory submissions and/or study start-up experience is required with strong technical knowledge performing Clinical Trial Applications in Argentina (ANMAT, CCIS)
Excellent written and verbal communication skills in English
Experience and/or technical knowledge in Import License extensions is a strong plus
Ability to plan, develop, and manage timelines, including keeping them up to date
Comfortable managing multiple projects and priorities at the same time
Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers
Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment

Job Responsibility

Performing Regulatory submissions in Argentina to ANMAT/ CCIS
Compiling submission dossier
Execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy
Interacting directly with Functional Service Providers for Ethics Committee Services, Clinical Project Management (Local Trial Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, Pharmacovigilance, Clinical Supply Chain and vendors acting as Importer of Record
Performing efficiently end-to-end Clinical Trials Regulatory submissions in country for new and ongoing project(s) or programs
Submitting, with the input of importer of record, study specific import licenses extensions until approvals
Communicating overall regulatory status to internal teams and service providers
Attending to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals
Collaborating with internal team members to establish timelines and clarify regulatory requirements
Maintaining clinical trial regulatory requirements' database, including regular updates to checklists

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Manager, CMC Operations

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 15, 2026

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