CMC Development Manager Job at Life Science Talent (Stockholm)

Client Engagement Manager, CMC

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobili...

Location

United States , Costa Mesa

Salary:

103170.00 - 158873.00 USD / Year

Hyundai AutoEver America

Expiration Date

Until further notice

Requirements

Bachelor's Degree or higher in a related field
5 + years of experience in a similar role such as client relationship/ key account management, preferably in the telematics, IT or automobile industry.
Consulting experience at a Big4 consulting company, highly desirable
Understanding of telematics services, fleet management, and connected vehicle solutions preferred.
Telecommunications experience preferred, with broad knowledge of various telecommunication products, services, networks, carriers, rate plans, contracts, and invoices
Ability to solve practical problems and deal with a variety of situations.
Ability to interpret difficult instructions, derive valid conclusions, and recommend reasonable courses of actions within the scope of the position.
Well organized with ability to pay close attention to details.
Strong interpersonal skills.
Able to collaborate effectively with cross-functional teams.

Job Responsibility

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobility service-related inquiries and requests from clients and partners.
Facilitates and lead new service-related contract development / amendments with clients, HMG affiliates and partners.
Engage in all aspects of client and partner interactions, collaborate with the Procurement team to manage vendor contracts and relationships, creation/negotiation with client companies, coordinate with all internal departments for client proposal creation, and provide consulting service to client companies.
Lead various projects related to account management, client service, and partner management.
Create/manage customer pricing model align with company's strategic direction
Create/manage wireless usage forecast model based on new services and vehicle volume.
Manage subordinate Business Analysts, as applicable
Staying abreast of service implementation and business operation status, keep clients informed and stay up to date with their connectivity service status
Functions as a key advocate for Client Business Units (CBUs)
Serve as a single point of contact for connectivity service-related inquiries and requests from clients

Fulltime

Senior Scientist I/II - Analytical Development (CMC)

The Senior Scientist will be responsible for managing analytical development, gu...

Location

United States , Brisbane

Salary:

150000.00 - 176000.00 USD / Year

Mammoth Biosciences

Expiration Date

Until further notice

Requirements

PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field with 3+ years of relevant industry experience
MS with 6 years of experience in a biotech/pharma setting
Scientist II: PhD + 5 years minimum experience or MS + 8 years minimum experience
Strong working knowledge of oligo/mRNA-LNP related analytical methods
Hands-on expertise with relevant analytical techniques for gene/cell therapies or complex biologics (e.g., HPLC, LC-MS, DLS, UV, ELISA, qPCR/ddPCR, particle/aggregate characterization, and/or enzymatic assays)
Strong understanding of ICH guidelines, phase-appropriate method validation, and regulatory expectations
Proven track record of guiding method qualification and validation in early phase settings
Experience managing analytical workflows at CDMO/CTLs
Excellent problem-solving, communication, and cross-functional collaboration skills
Ability to regularly work onsite at our Brisbane, CA location

Job Responsibility

Support analytical method development and implementation, both internally and via contract labs, to support the characterization, release testing, and stability of CRISPR-based drug substance and drug product
Establish internal capabilities for select analytical assays in R&D labs, including method qualification and troubleshooting for nucleases, guide RNAs, and delivery vehicles
Manage relationships with external testing labs (CTLs) and manufacturing partners (CDMOs) to ensure method development, validation, and transfer meet project timelines and regulatory expectations
Draft and review protocols, reports, and method qualification and validation documentation in compliance with ICH and relevant regulatory guidelines
Provide technical leadership on assay design and analytical strategy, ensuring methods are phase-appropriate, scalable, and tailored for novel CRISPR-based genetic medicines
Support preparation of CMC documentation for regulatory submissions (e.g., INDs)
Evaluate and implement emerging analytical technologies that align with ultracompact CRISPR platform and pipeline needs
Help build and mentor a small team as the company scales

What we offer

Company-paid health/vision/dental benefits
Unlimited vacation and generous sick time
Company-sponsored meals and snacks
Wellness, caregiver and ergonomics benefits
401(k) with company matching

Fulltime

Director, CMC Biologics

Proclinical is seeking a Director, CMC Biologics to lead and execute Chemistry, ...

Location

United States , San Francisco

Salary:

225000.00 - 260000.00 USD / Year

Proclinical

Expiration Date

Until further notice

Requirements

Advanced degree (PhD, MS, or BS) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field
Strong experience in biologics CMC development, including late-stage clinical development and regulatory filings
Expertise in protein therapeutic development, manufacturing, and managing CDMOs in a virtual biotech model
In-depth knowledge of FDA and ICH CMC requirements for biologics
Proven track record in planning and executing biologics CMC development, GMP manufacturing, and regulatory submissions
Experience with monoclonal antibodies and fusion proteins
Strategic thinker with strong project management, organizational, and communication skills
Ability to operate effectively in a lean, fast-paced environment with a high level of accountability

Job Responsibility

Develop and implement integrated CMC strategies aligned with clinical development plans and timelines
Lead CMC activities from late preclinical stages through regulatory filings for all clinical phases
Define and execute phase-appropriate control strategies and proactively address CMC risks
Oversee formulation, process, and analytical development, including upstream/downstream processes and drug product formulations
Manage CDMO selection and oversight for biologic development, manufacturing, and tech transfer
Ensure cGMP compliance, adherence to timelines, budgets, and quality standards
Author and review CMC sections for regulatory filings and support agency interactions
Collaborate cross-functionally with Quality, Regulatory, Clinical, Nonclinical Development, Commercial, and Finance teams to align CMC strategies with program goals
Develop and manage CMC budgets and integrate timelines into overall program plans

Fulltime

Project Manager - Pharmaceutical Development

You will be responsible for planning, coordinating, and executing cross-function...

Location

United Kingdom

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific field
PMP, Prince2, or equivalent project management certification
5+ years of project management experience within pharmaceutical or biotechnology development
Experience working with global teams and external vendors
Demonstrated experience managing cross-functional development projects
Strong understanding of drug development lifecycle and CMC processes
Proficiency with project management tools (e.g., MS Project, Smartsheet, Jira, or equivalent)
Excellent communication, organizational, and stakeholder management skills

Job Responsibility

Lead and manage pharmaceutical development projects across formulation, analytical, CMC, clinical supply, and regulatory functions
Develop and maintain detailed project plans, timelines, budgets, and risk registers
Coordinate cross-functional teams including R&D, QA, QC, Regulatory Affairs, manufacturing, and external partners (CROs, CMOs)
Track project milestones, deliverables, and dependencies
proactively identify and mitigate risks
Facilitate project meetings, prepare agendas, document decisions, and communicate progress to stakeholders and leadership
Ensure compliance with GMP, GLP, GCP, and applicable regulatory guidelines (FDA, EMA, ICH)
Manage change control processes and assess impact on scope, timelines, and cost
Support preparation for regulatory submissions, audits, and inspections as needed
Maintain accurate project documentation and reporting dashboards

What we offer

Active Social and charity committee
Cycle to Work Scheme
Electric Vehicle Scheme
Eye Care Vouchers

Fulltime

New

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

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

Director of Regulatory Affairs, CMC

Hemab is seeking a Director of Regulatory Affairs, CMC to lead global regulatory...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences, chemistry, engineering, or related scientific discipline required
Advanced degree (MS, PhD, PharmD) preferred
8+ years of pharmaceutical/biotechnology industry experience with at least 5 years in regulatory affairs with significant CMC focus, or equivalent combination of technical CMC and regulatory experience
Demonstrated experience with biologics CMC regulatory submissions (INDs, BLAs) and successful health authority interactions
Track record of developing successful CMC regulatory strategies for complex biologics and/or peptides through various stages of development
Experience with preparing global regulatory submissions to FDA and EMA as well as ex-US/EU regulatory Agencies (e.g., PMDA, Health Canada)
Familiarity with submission requirements for Regulatory Agencies in Middle East, Latin America and Asia is highly desirable
Deep understanding of global CMC regulatory requirements and guidance documents for biologics, including ICH guidelines (Q5, Q6, Q8-Q11)
Strong scientific acumen with ability to understand and communicate complex technical CMC information
Demonstrated ability to think strategically while managing tactical execution

Job Responsibility

Lead the development and execution of global CMC regulatory strategies for biologic products, including gene therapies
Serve as the CMC regulatory representative on cross-functional project teams, providing strategic input and guidance
Author and/or review CMC sections of regulatory submissions including INDs, CTAs, BLAs/MAAs, and amendments
Collaborate closely with CMC technical teams (Process Development, Analytical Development, Manufacturing, Quality)
Lead CMC regulatory aspects of health authority interactions, including preparation of briefing documents, responses to agency questions, and participation in regulatory meetings
Proactively identify CMC regulatory risks and develop mitigation strategies
Provide regulatory assessment and strategic guidance for CMC changes throughout the product lifecycle
Oversee CMC regulatory activities conducted by external vendors and consultants
Monitor evolving global CMC regulatory landscape, guidelines, and precedents
Partner with Quality Assurance to ensure CMC activities align with GMP requirements and support regulatory inspections readiness

Fulltime

CMC Project Management Specialist

Join Enveda as a CMC Project Management Specialist in a remote capacity and help...

Location

United States

Salary:

95000.00 - 115000.00 USD / Year

Enveda

Expiration Date

Until further notice

Requirements

B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar degree
1-2+ years of CMC project management experience in biotech or pharma, with exposure to drug substance and drug product development
Ability to manage cross-functional projects and communicate technical details clearly
Experience working with external CROs and CDMOs

Job Responsibility

Lead cross-functional planning and execution of CMC development activities across drug substance and drug product
Partner with internal and external teams to define and track development strategies, timelines, and deliverables
Oversee and monitor external CRO and CDMO activities, including planning, communication, and batch execution timelines
Develop and manage detailed CMC project plans, ensuring timely delivery through proactive communication and follow-up

What we offer

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

Fulltime

CMC Development Manager

Life Science Talent

Location:
Sweden , Stockholm

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 14, 2026

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