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

Senior Manager, CMC Operations

Reporting to the Senior Director, CMC Operations, the Senior Manager, CMC Operat...

Location

United States , San Diego

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of experience in pharmaceutical drug development and track record of success supporting multiple projects or programs simultaneously
Excellent communication/presentation skills and proficiency in Smartsheet software
Proven track record of creativity, problem solving, and productivity
Demonstrated success working in interdisciplinary and cross-functional teams
Comfortable working in a dynamic, interactive, fast-paced, and entrepreneurial environment
Bachelor’s degree in a scientific discipline

Job Responsibility

Drive Tech Ops, Quality, and Regulatory teams to ensure project priorities are clearly documented and communicated
Manage the CMC vendors to ensure all work is occurring according to the contracted scope, schedule, and budget
Responsible for the tracking of program budget and finances for CMC functions
Create and independently maintain project communication tools, such as CMC team meeting minutes, action tracking, and timeline plans
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholders
Define and monitor progress on deliverables and provide timely updates to key stakeholders on project target dates and progress against goals
Actively manage relationships and communication between Kailera and external partners or service providers as required

What we offer

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

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

New

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

Executive Director, Medicine Development Leader

GSK is seeking a highly skilled Executive Director, Medicine Development Leader ...

Location

United States; United Kingdom , Waltham; London; Stevenage; Collegeville

Salary:

242250.00 - 403750.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical and Commercial
Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
Experience building budgets and leading the strategic and budget planning process
Experience the healthcare environment, and access in all major markets

Job Responsibility

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
Work with the functional line Heads supporting RIIRU to select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and Target Medicine Profile (TMP) which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

Senior Director, Analytical Development and Quality Control

The Altos Institute of Medicine will capture knowledge generated about cell heal...

Location

United States , Redwood City

Salary:

283900.00 - 384100.00 USD / Year

Altos Labs

Expiration Date

Until further notice

Requirements

Ph.D. in analytical sciences or biological sciences
Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry
10+ years of Management experience
Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy
Experienced in leading CMC team and analytical subteam
Proficient in cGMP’s and pharmaceutical industry procedures and regulations
Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations
Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs

Job Responsibility

Lead analytical development and quality control across multiple modalities
Build a high performing team and establish internal and external analytical and QC capabilities
Serve as CMC lead and analytical lead for Altos therapeutic programs
Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, release and stability testing, and in-process testing
Establish product specifications to ensure product quality
Support technical assessment of Out of Specification and Non-Conforming investigations
Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion

Fulltime

New

Senior QA Manager Validation & Quality

This role combines deep expertise in validations (e.g process, cleaning, analyti...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Advanced degree (Ph.D. or M.S.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline
15+ years of relevant biopharmaceutical industry experience, including significant roles in QA process development, manufacturing and validation
Strong knowledge and experience of biotech and aseptic manufacturing incl testing
Deep understanding of regulatory requirements (FDA, EMA, ICH) related to development, manufacturing and validation
Strong experience managing external partners and CDMOs/CMOs
Strong experience of Authority inspections as presenter, coordinator (FDA, EMA and other markets)
Proven track record of leading validation activities for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages
Strong communication, and interpersonal skills with the ability to influence across functions and levels
Strong problem-solving skills and a hands-on, execution-oriented mindset

Job Responsibility

Provide strategic and operational direction for quality expectation including validation within drug substance and drug product process development, scale-up, technology transfer, and manufacturing activities
Oversee development and implementation of quality and validation processes to ensure compliant, robust and cost-effective manufacturing processes for development, clinical and commercial supply
Manage external manufacturing partners (CDMOs/CMOs), ensuring alignment with quality expectations and program objectives
Support authority inspection and internal Hansa/external audits of suppliers and vendors
QA review and approval of validation documentation
Partner cross-functionally with CMC, Regulatory, Clinical, Supply Chain
Establish and maintain strong relationships with internal and external stakeholders to ensure seamless execution of QA strategies and operational tasks
Drive continuous improvement initiatives such as -evaluate and update the Quality Management System (QMS), proactively identify areas for improvement

What we offer

A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions
The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people
An opportunity to build a fully integrated biopharmaceutical company with global outreach
An open-minded and welcoming atmosphere
Friendly, motivated and skilled colleagues with whom you can both laugh and work

Fulltime

Drug Substance Senior Specialist – Biologics

We are seeking a Drug Substance Senior Specialist with strong experience in biol...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field
8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs
Proven experience with PPQ and process characterization for antibody drug substances
Solid understanding of ICH Q8–Q11 and global validation expectations
Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions
Experience in early-stage process development and scale-up
Strong project management and organizational abilities
Excellent communication and technical writing skills for regulatory documentation
Collaborative mindset and ability to work effectively with external partners
Flexible, proactive, and comfortable operating in a fast-paced biotech environment

Job Responsibility

Support early-stage antibody programs by applying phase-appropriate development strategies
Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches
Provide technical input to CDMOs on process design, scale-up, and risk assessments
Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs
Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights
Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations
Support implementation of continuous process verification (CPV) and lifecycle validation strategies
Oversee technology transfer to external manufacturing partners for commercial readiness
Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy
Coordinate comparability studies and process optimization activities with CDMOs

Fulltime

Senior Director, Drug Substance Development and Manufacturing

Lead and oversee all outsourced drug substance manufacturing operations. Reporti...

Location

United States , Waltham; San Diego

Salary:

210000.00 - 270000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing
Deep expertise in both synthetic and recombinant manufacturing approaches
Hands-on experience with the synthesis and manufacturing of peptides is mandatory
Demonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activities
Sound technical skills in applying scientific principles to complex process design, implementation, and successful technology transfer
Solid knowledge of current Good Manufacturing Practices (cGMPs), Quality systems, and global regulatory requirements (e.g., FDA, EMA)
Proven experience with the drafting, review, and authoring of CMC sections for major global regulatory submissions (e.g., IND, NDA, MAA)
Exceptional solution-based critical thinking skills and the ability to operate with a keen sense of urgency and an entrepreneurial spirit
Demonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issues
Ability to strategically contribute to and manage multiple concurrent projects

Job Responsibility

Direct and lead all process development, scale-up, technology transfer, and validation activities for peptide drug substance manufacturing across all Contract Development and Manufacturing Organizations (CDMOs)
Establish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO network
Define the long-term vision for manufacturing by maintaining a deep knowledge of industry trends, technological advancements, green manufacturing processes, and emerging regulatory changes
Manage and enforce CDMO performance against key project timelines, deliverables, and costs
Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners
Oversee budget planning and forecasting for all outsourced drug substance manufacturing activities
Serve as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs
Oversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA)
Direct the preparation and final authorship of high-quality technical reports, executive summaries, and presentations to effectively communicate results and progress to internal leadership and external stakeholders

What we offer

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

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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