Director, CMC Product Development Job at Life Science Talent (København)

Director, Product Quality Leader

This individual will serve as a technical quality expert for one or more product...

Location

United States

Salary:

164000.00 - 225500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or related field required
Advanced degree desirable
12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
Preferred experience in biologics product development and licensure or technical support
Experience in both clinical and commercial phases of product lifecycle is highly desirable
Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
Excellent interpersonal and communications skills
Demonstrated strong leadership capability
Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
Highly capable of building strong, effective working teams

Job Responsibility

Serve as a technical quality expert for one or more products during clinical development through post-commercialization
Make technical quality-related decisions
Serve as the single point of contact on the CMC team for all quality functions, risks and issues
Provide efficient and effective quality leadership of CMC-related strategic activities
Drive associated quality decisions
Participate fully in CMC team meetings and other relevant technical forums
Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives
Accountable for creation of the product-specific Quality strategy
Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
Own and manage the product quality risk register

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Medical Director, Clinical Development

We are seeking an experienced, highly motivated Medical Director, Clinical Devel...

Location

United States , Waltham; San Diego

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
Can work independently
self-starter attitude
MD or equivalent is required

Job Responsibility

Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators

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, 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

Executive Director, Process Development

In this vital role, you are responsible for scientific and technical leadership ...

Location

United States , Juncos

Salary:

268622.00 - 321865.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of Scientific, Process Development and/or Technical Service experience
Master’s degree and 10 years of Scientific, Process Development and/or Technical Service experience
Bachelor's degree and 12 years of Scientific, Process Development and/or Technical Service experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Drug substance technology and analytical method transfer to and from the site
Process validation at scale across the two DS manufacturing plants
Drug substance and Attribute science CMC authoring activities for products, the latter in partnership with Attribute Sciences
Process monitoring activities, including real time multi-variate statistical process monitoring
Life cycle improvements in commercial process, including improvements to increase yields and reduce cost of goods manufactured
Ensure manufacturing operations are aligned with the registered process
Provide oversight and support for technical investigations
Safety and compliance of process development activities
Developing strategy, setting goals and priorities, allocating resources, monitoring project progress, and managing the organization’s budget

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

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

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Director of RA CMC

About company: A pre-IPO biotech

Location

China , Shanghai

Salary:

1000000.00 - 1400000.00 CNY / Year

Randstad

Expiration Date

June 03, 2026

Requirements

Advanced degree (Ph.D. preferred, M.S. required) in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field
Minimum of 10 years of combined experience in CMC development (process, analytical, formulation) and Regulatory Affairs CMC within the pharmaceutical industry
Experience with device-drug combination products is a plus
Proven track record of successfully developing and implementing global CMC regulatory strategies from Phase 1 through approval
Extensive experience authoring CMC sections for major filings (IND/NDA) and leading health authority interactions
Comprehensive knowledge of US, EU, and ICH CMC guidelines
Must understand the scientific and technical nuances of oligonucleotide synthesis, purification, analytics, and stability
Outstanding written and verbal communication skills in English are mandatory
Demonstrated ability to think strategically, anticipate regulatory challenges, and develop innovative solutions
Strong leadership presence with the ability to influence and align cross-functional teams without direct authority

Job Responsibility

Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval
Regulatory Submission Leadership: Serve as the Regulatory CMC Lead for major filings. Author, review, and critically assess high-quality CMC sections for all global regulatory submissions
Health Authority Interactions: Lead the preparation, coordination, and execution of all CMC-focused interactions with global health authorities
Expert Guidance on Complex Products: Act as the in-house subject matter expert on global regulatory CMC requirements for complex oligonucleotide-based products, including device-drug combination products
Strategic Liaison & Collaboration: Serve as the primary regulatory liaison between the CMC department and the broader Regulatory Affairs team

Fulltime

Director, CMC Product Development

Life Science Talent

Location:
Denmark , København

Category:
Research and Development

Contract Type:
Employment contract

Salary:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
May 16, 2026

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Director, CMC Product Development

Life Science Talent

Location:Denmark , København

Category:Research and Development

Contract Type:Employment contract

Salary:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:May 16, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Director, CMC Product Development

Director, Product Quality Leader

Medical Director, Clinical Development

Senior Director, Analytical Development and Quality Control

Executive Director, Process Development

Director, CMC Biologics

Associate Director, CMC Regulatory Affairs

Associate Director Regulatory Affairs

Director of RA CMC

Location:
Denmark , København

Category:
Research and Development

Contract Type:
Employment contract

Job Posted:
May 16, 2026