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Regulatory Cmc Jobs

Cmc Senior Project Manager
By SSi People At United States
Microsoft Project (or equivalent project management software) and Microsoft Office skills
At least 2-years of experience as a project manager
10-years of experience in the Pharmaceutical, Biotechnology or Biomedical related field, direct CMC experience is highly desirable
Facilitation and soft skills to work with cross functional teams
Critical thinking and problem-solving skills
Develop and use project plans and schedules to measure and report progress.
Senior Manager, Cmc Program Management
By Alexion Pharmaceuticals, Inc. At Boston, MA, United States
Strong track record in executing effective program management skills in cross-functional matrix organizations.
Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
Provides key updates on program risks, progress and mitigation plans to management as needed.
Responsible for program/project level budgeting and resource management
Leads operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.
Prepares and manages governance interactions in partnership with the CMC Lead.
Associate Director, Regulatory Cmc
By BioSpace At San Diego, CA, United States
Strong sense of planning and prioritization, and the ability to work with all levels of management.
Ensure that CMC content is complete, well-written, and meets all relevant requirements.
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.
Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.
Excellent interpersonal skills to communicate difficult concepts and persuade others.
Strategic thinking and strong problem-solving skills with outstanding attention to detail.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Philadelphia, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Boston, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Sr. Manager, Cmc Operations Program Management
By Life Edit Therapeutics At Durham, NC, United States
2+ years of CMC Program Management experience in biomedical industry. Cell/gene therapy preferred.
Experience working with project management tools such as MS Project, MS Teams, MS Excel or Think-Cell; Smartsheet experience a bonus
Own the CDMO project management relationship and support tech transfer and CDMO management with LETI and ElevateBio Base Camp SMEs
1-2+ years of experience working with FDA- and/or EU-regulated Quality systems
Strong communication skills with ability to build professional relationships with external and internal stakeholders a must
SAP experience or similar ERP system is preferred
Cmc Project Manager Jobs
By SSi People At United States
Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings
Job Title: CMC Project Manager - Remote
Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables
Assist PD in driving decision making and communication
Pay Rate: $70/hr to $75/hr
Vice President, Cmc Jobs
By CBMG Holdings At Rockville, MD, United States
•Hands on experience in oversight and management of CMC activities and thorough knowledge of GMP requirements.
•Expert knowledge of GMP and FDA regulatory requirements applicable to Biologics including Cell therapy products.
•Previous cell therapy experience is a must.
•Strong knowledge of current industry trends and ability to use the latest technologies
•Provide strategic leadership and direction to the manufacturing, process development, and supply chain teams.
•Hire, develop, and retain top talent in the manufacturing, process development, and supply chain teams.
Cmc Project Manager Jobs
By Integrated Resources, Inc ( IRI ) At Warren, NJ, United States
Apply project management expertise across the portfolio for standard and complex projects, managing multiple projects in parallel.
Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
Report on project progress, offer viable solutions and opportunities as they arise
Work with internal and external stakeholders to manage project deliverables, e.g., CMOs, Supply Chain, etc.
Excellent interpersonal, communication, and presentation skills.
Strong leadership skills and executive presence; ability to positively influence outcomes.
Remote In Ma: Regulatory Cmc Consultant (233298)
By Black Diamond Networks At United States

Job Description: Our biotech client needs a Regulatory CMC Consultant. Job is Part-time. Some CAR-T experience is wanted for this. Some other projects are gene therapy which are on the backburner ...

Hr Business Partner, Executive Director- Technical Development And Cmc Regulatory
By Gilead Sciences At Foster City, CA, United States
Demonstrates in-depth consulting, influencing, negotiating, and conflict management/resolution skills.
Prior experience and desire to manage a geographically disperse team. Is a champion, coach and mentor for the development of others.
12+ Year experience in Human Resources
Experienced HR professional with pharmaceutical/biotechnology industry required.
Experience working in Tech Development, CMC Reg operations or Research & Development required
Experience working in countries with a different/diverse cultural and business background
Cmc Regulatory Technical Writer - Remote
By Synectics Inc. At United States
Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company
Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation.
Ad hoc RA CMC support to line manager.
Good writing skills for technical writing
***Compensation is based on experience***
Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders.
Director, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Cmc Regulatory Affairs Consultant
By EPM Scientific At California, United States
Participate in the design, development and execution of regulatory strategies, regulatory risk management and contingency plans.
Proactively manage CMC aspects including overseeing preparation and submission of CMC submissions - including clinical trial applications.
Develop and assess CMC content to ensure it is complete, well-written, and meets all pertinent requirements.
10+ years’ experience in life sciences
5+ years’ relevant experience in regulatory affairs or related functions in drug or biologics development.
Experience as a regulatory contributor for global original IND, NDA, BLA MAA, filings in the US or Europe.
Sr Director Regulatory Affairs Cmc
By Discover International At United States
Extensive knowledge of global regulatory requirements and guidelines for CMC in drug development.
Provide strategic guidance on CMC requirements for drug development programs.
Strong leadership skills, with a track record of managing high-performing teams.
Excellent communication and interpersonal skills for effective collaboration.
Strong problem-solving and strategic thinking abilities.
Develop and implement global regulatory CMC strategies aligned with corporate objectives.
Senior Vice President, Cmc
By BioSpace At San Diego, CA, United States
Minimum of fifteen years’ experience in a senior management level role in CMC, with increasing responsibilities.
Play a key role in developing and implementing integrated CMC regulatory strategies for AnaptysBio’s pipeline projects.
B.S is required, PhD preferred.
Position may require occasional evening and/or weekend commitment
Position may require domestic and international travel
Drug Device Combination Cmc Support (Contract)
By Vertex Pharmaceuticals At , Boston, 02210, Ma $70 - $80 an hour
Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
Performs Data Entry into GxP Regulated Systems as required
Bachelor’s degree and 3-5 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background.
Strong written and verbal communication skills
The ideal candidate will have experience with design history file, FDA 21 CFR part 820 and ISO-13845.
The responsibilities of this position may include, but are not limited to, the following:
Social Worker Bsw- Cmc Main- Pt 30 Hrs.
By Atrium Health At , Charlotte, 28203, Nc
Coordinates and facilitates post hospital planning for patients and patient's support system in conjunction with the Clinical Care Management team.
Works with Clinical Care Management leadership to identify problems, recommended solutions and works toward resolution and efficient discharge planning.
Intervenes in crisis situations, appropriately and effectively applying crisis intervention theory and skills
Maintains current knowledge and researches availability of community agencies and community resources for social, emotional or financial assistance.
Cmc Modeling Engineer Jobs
By GE Aerospace At Evendale, OH, United States
A minimum of years of engineering experience.
Strong oral and written communication skills.
Skilled with Object Oriented Programming Languages such as C/C++ and Python
Experience with data and statistical analyses
Lead and advance technology readiness levels for CMC process models.
Develop and execute CMC roadmaps that support component durability, performance, and cost out.
Senior Director, Cmc Jobs
By BioSpace At New York, NY, United States
Identification, selection and management of CDMOs for process development, process optimization, GxP manufacturing and analytical activities for drug-substance and drug-product
Direct experience working with FDA, including knowledge of current ICH guidelines
In depth understanding of modern process development, solid state characterization, hands on cGMP manufacturing and CDMO management
Establish and manage all CMC internal and external activities related to process development, manufacturing and validation for our programs
Ph.D. in Chemistry or related discipline with at least 15+ years of industrial experience in Process Chemistry and Drug Development
Strong track record of drug discovery experience, success, and leadership, exemplified by advancement of programs through multiple stages of development