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

Senior Director, Product Quality Assurance

The Senior Director, Product Quality Assurance, Cambridge (PQA) will be responsi...

Location

United States , Cambridge

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline
15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality. Must have CT/GT/biologics experience
7+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment
Experience in auditing/vetting of CDMOs
Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Established expertise and training in GxP systems
Ability to evaluate Quality Systems and drive value added enhancements
Strong team player that has a customer service approach and is solution oriented

Job Responsibility

Creating/monitoring and maintaining phase appropriate levels of compliance in all of our CDMOs/external partners
Overall responsibility to ensure initiatives related to quality and compliance are optimized and executed appropriately in the areas of GMP compliance with Beam’s externally focused manufacturing efforts
Provide top level guidance and support on internal GMP activities in the Cambridge location, and globally from a GMP perspective
Quality oversight for GMP operations, primarily encompassing external GMP operations and QC support in Cambridge
Key relationship manager for CDMOs/external partners from a quality perspective
Works cross-functionally with other members of the greater CMC area and program teams for CDMO selection and vetting
Establishes an overall KPI and metrics program to assist in governing the CDMO relationships
Establishes a routine process for continuous improvement of the CDMO oversight processes
Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities
Create and ensure appropriate quality systems are in place to support product release in a compliant and timely manner

Fulltime

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

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

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

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

Director, CMC and Device Regulatory Affairs

The Director, CMC and Device Regulatory Affairs will lead the implementation of ...

Location

Salary:

220000.00 - 240000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum of 10 years of industry experience
At least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
Proven track record of leading cross-functional submission teams and successful regulatory submissions
Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
Excellent communication, leadership, and project management skills
Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless

Job Responsibility

Develop and implement global CMC and device regulatory strategies for assigned program(s)
Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
Identify regulatory risks associated with product development and propose mitigation strategies
Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Director, CMC Regulatory Affairs

Reporting to the Vice President, CMC Regulatory, the Director of Regulatory Affa...

Location

United States , Waltham

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years regulatory CMC experience, including experience as a regulatory CMC product lead, or equivalent industry experience
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
Able to work independently and complete projects with minimal oversight, escalating issues to regulatory management with discretion
Self-starter and results-oriented individual with outstanding work ethic
must be able to perform in a fast-paced environment
Demonstrates leadership, problem-solving ability, attention to detail, flexibility, and values teamwork
Exercises good judgement in elevating and communicating actual or potential issues to line management
Ability to multi-task and adjust priorities quickly while working under tight deadlines
Experience using electronic document management systems and document review tools

Job Responsibility

Responsible for one or more product(s) and supports the regulatory CMC team in the development & execution of global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities
Define CMC content (data and documentation) requirements for regulatory submissions and conformance with established requirements
Leads CMC preparation activities for meetings with Health Authorities on CMC related matters
Ensure timely preparation of CMC documents and responsible for handing off submission ready documents for regulatory submissions
Contribute to the evaluation of change proposals for global regulatory impact and support planned global variations and amendments
Identify and communicate critical topics and risk promptly to the regulatory CMC team
Oversee the copyediting, finalization, approval, and hand-off of documents for publishing

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, CMC Operations

Manage the flawless execution of Kailera’s CMC activities, spanning departmental...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in pharmaceutical drug development, clinical and/or commercial manufacturing familiarity, 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, particularly when no or minimal precedent is in place
Demonstrated successful experience with working in interdisciplinary and cross-cultural teams
Bachelor’s degree in a scientific discipline preferred

Job Responsibility

Support execution of CMC-related projects, culminating in the successful preparation of regulatory submissions and product approvals
Actively support Tech Ops strategies and goals by participating in and/or leading cross-functional CMC sub-teams
Work closely and collaboratively with Tech Ops, Quality, Regulatory, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management activities
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members
Ensure quality, quantity, and timelines in all assigned projects
Update team members on project target dates and priorities. Proactively contributes to budget forecasts and tracking expenses

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Select Country

Director, CMC Product Development

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?