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

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

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

Vice President, Biostatistics

The Vice President, Biostatistics is a key enterprise leader responsible for set...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

PhD or Master’s degree in Biostatistics, Statistics, or related field
10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs
At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups
Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions
Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams
Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred
Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness
Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences
Experience managing departmental budgets, vendor relationships, and technical infrastructure
Highly collaborative, with strong interpersonal skills and the ability to build trust across teams

Job Responsibility

Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture
Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio
Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making
Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success
Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings
Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning
Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies
Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation
Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making
Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials

What we offer

health and retirement
PTO
stock option plans

Director/senior director, program management

As an experienced Program Manager, you will play a critical role in achieving ou...

Location

United States , Cambridge

Salary:

210000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

12+ years of experience in the life sciences industry
at least 5 years of demonstrated program management experience leading cross-functional teams in biotechnology
BS required
preference for candidates holding an advanced degree (MS, PhD, MBA, etc.)
experience driving cell and/or gene therapy programs is strongly preferred
candidates must live locally and be able to visit our Cambridge location 1–3 days per week as needed
proven ability to manage competing priorities, influence and integrate diverse teams, identify barriers, and manage budgets, timelines, and meeting plans
demonstrated strategic leadership skills, including the ability to influence senior stakeholders and drive decision-making in complex, matrixed environments
experience managing multiple programs or contributing to portfolio strategy and governance
expertise in risk management, scenario planning, and contingency development

Job Responsibility

Overall accountability for program operations
drive the BEAM-302 program team by partnering closely with the Program Lead and cross-functional program team members to manage all operational aspects of the program
lead and operationalize program activities across manufacturing, clinical development, CMC, regulatory, and other cross-functional teams to ensure seamless integration and alignment with BEAM-302 objectives
manage and integrate program plans and cross-functional deliverables (e.g., timelines, budgets, resource allocation, identification of risks and barriers, identification of mitigation plans, development of scenarios, and integration of key documents like TPPs and IDPs)
ensure cross-functional alignment and organizational support for the program plan by facilitating internal and external stakeholder management, as well as communicating program updates at internal forums
provide strategic input into program objectives and ensure alignment with corporate goals
drive scenario planning and trade-off discussions to enable informed decision-making at governance forums
establish proactive risk management frameworks and ensure timely escalation of critical issues
develop contingency plans for high-impact risks and communicate mitigation strategies to leadership
drive cross-functional initiatives that support operational excellence

Fulltime

Global Labeling Operations Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Mexico , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field
advanced degree (MSc, PhD, PharmD) preferred
Fluency in English (verbal and written)
additional languages a plus
Minimum 3 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations
Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
Experience with flu campaigns, pandemic products, and direct-to-consumer advertising
Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems
Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS
Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing

Job Responsibility

Manager internal global labeling and drug safety activities and coordinate bi-weekly updates
Coordinate readability testing (planning, team review, and communications)
Oversee translations for foundational markets (EU, CH, DE)
Coordinate and upload CH labels to AIPS
submit approved labels to external platforms (HA, ePIL)
Upload approved labels to internal systems (Documentum, Weblabel, intranet)
Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders
Perform data entry in Trackwise/Veeva and prepare annual labeling reports
Review and update submission content plans
prepare change control documentation for CCDS-driven changes

What we offer

Competitive compensation, benefits, and opportunities for career growth
Flexible work arrangements
Supportive and inclusive environment
Opportunities for career growth
Diverse and global client exposure
Learn from experts

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

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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