Senior Manager CMC Quality Control Writer
3 weeks ago
We are seeking a highly motivated and experienced Quality Control Manager to join our team at Tandym Group. As a Senior Manager CMC Quality Control Writer, you will be responsible for ensuring the quality of our products and processes.
Responsibilities:- Review and analyze QC data for commercial and clinical programs
- Collaborate with CMOs and CLs to ensure quality standards are met
- Work closely with cross-functional departments to achieve corporate goals
- Develop and implement quality control procedures and protocols
- Write and review CMC stability sections for regulatory filings
- Address CMC stability inquiries and perform review/draft of analytical release and stability data
- Bachelor's degree in Biochemistry, Molecular Biology, or Pharmaceutical Sciences
- 5+ years of experience in analytical/QC in a GMP environment
- Proficient in project and personnel management, MS Office, and Excel
- Experience with writing and reviewing CMC filings for regulatory submissions
- Good oral and written communication skills
- Working experience and knowledge in quality control release and stability methodologies
- Understanding of cGMPs, ICH, and regulatory drug requirements
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Senior Manager CMC Quality Control Writer
2 weeks ago
Reston, Virginia, United States Tandym Group Full timeJob Title: Senior Manager CMC Quality Control WriterWe are seeking a highly motivated and experienced Quality Control Manager to join our team at Tandym Group as the Senior Manager for CMC Quality Control Department.Responsibilities:Oversee all aspects of QC data review for commercial and clinical programs, including modalities and molecules.Collaborate with...
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CMC Quality Control Manager
2 weeks ago
Reston, Virginia, United States Planet Pharma Full timeJob Title: CMC Quality Control ManagerWe are seeking a highly motivated and experienced professional as CMC Quality Control Manager for our Quality Control department, with the passion and creativity to support development of great medicines for rare and ultra-rare diseases.Job Summary:The CMC Quality Control Manager will be responsible for all aspects of QC...
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Senior Manager, CMC QC Writer and Reviewer
1 month ago
Reston, Virginia, United States Beacon Hill Full timeJob SummaryWe are seeking a highly motivated and experienced professional as Manager/Senior Manager for CMC Quality Control department, with the passion and creativity to support development of great medicines for rare and ultra-rare diseases.Key ResponsibilitiesAuthor, draft, review, and approve the Regulatory QC CMC sections of our IND/IMPD and BLA/NDA...
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Senior Director, CMC
1 month ago
Reston, Virginia, United States Meet Full timeJob Title: Senior Director, CMCJob Summary: Meet is seeking a highly experienced Senior Director, CMC to lead and oversee CMC activities related to drug substance and drug product development, manufacturing, and supply chain. The successful candidate will play a critical role in ensuring robust and scalable manufacturing processes for clinical and commercial...
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Senior Proposal Writer
3 weeks ago
Reston, Virginia, United States Leidos Full timeJob Title: Senior Proposal WriterLeidos is a leading provider of innovative solutions for the defense, intelligence, and civilian markets. We are seeking a highly skilled Senior Proposal Writer to join our team.Job Summary:The Senior Proposal Writer will be responsible for developing high-quality proposals that meet the needs of our clients. This includes...
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Senior Proposal Writer
1 month ago
Reston, Virginia, United States Leidos Full time{"title": "Senior Proposal Writer", "description": "Job SummaryLeidos is seeking a highly skilled Senior Proposal Writer to join our team. As a key member of our Capture Excellence team, you will play a critical role in developing high-quality proposals that drive business growth and success.Key ResponsibilitiesLead the development of clear, compliant, and...
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Senior Proposal Writer
1 month ago
Reston, Virginia, United States Leidos Full time{"title": "Senior Proposal Writer", "description": "Job SummaryLeidos is seeking a highly skilled Senior Proposal Writer to join our team. As a key member of our Capture Excellence team, you will be responsible for developing clear, compliant, and compelling proposal sections and volumes.Key ResponsibilitiesLead the development of proposal sections and...
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Senior Proposal Writer
10 hours ago
Reston, Virginia, United States Leidos Full timeJob Title: Senior Proposal WriterLeidos is seeking a highly skilled Senior Proposal Writer to join our team. As a key member of our Capture Excellence team, you will be responsible for developing clear, compliant, and compelling proposal sections and volumes.The ideal candidate will have a strong background in proposal writing, with experience in U.S....
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Senior Proposal Writer
4 days ago
Reston, Virginia, United States Demo - Maximus Full timeJob SummaryWe are seeking a highly skilled Senior Proposal Writer to join our team at Maximus. As a Senior Proposal Writer, you will be responsible for developing high-quality proposals that meet the needs of our clients and help us win new business.Essential Duties and Responsibilities:Write compelling and compliant proposals for government contracts,...
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Senior Technical Writer
4 days ago
Reston, Virginia, United States LanceSoft, Inc. Full timeJob Title: Senior Technical WriterJob Summary:LanceSoft, Inc. is seeking a highly skilled Senior Technical Writer to join our team. As a Senior Technical Writer, you will be responsible for creating high-quality technical documentation that supports the development, production, and use of our products and services.Key Responsibilities:Develop and maintain...
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Senior Proposal Writer
1 week ago
Reston, Virginia, United States Leidos Full timeSenior Proposal WriterLeidos is seeking a highly skilled Senior Proposal Writer to join our industry-leading Proposal Operations Team. As a key member of our team, you will play a critical role in developing high-quality proposals that showcase our company's expertise and capabilities.Key Responsibilities:Work closely with Solution Architects and Subject...
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Senior Grant Writer
1 month ago
Reston, Virginia, United States Women's Business Development Council Full timeJob Title: Senior Grant WriterWe are seeking a highly skilled and experienced Senior Grant Writer to join our team at the Women's Business Development Council (WBDC). As a key member of our team, you will be responsible for researching, developing, and submitting successful grant proposals to corporate, federal, and state government agencies, as well as...
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Senior Director, CMC Development Lead
1 month ago
Reston, Virginia, United States Fraser Dove International Full timeSr. Director - CMC Development OpportunityFraser Dove International is partnering with a leading healthcare organisation to find an innovative leader to oversee CMC Development and lead the manufacturing operations of radiopharmaceutical products.Your Key Responsibilities:Lead multidisciplinary teams to develop, manufacture, and supply novel PET...
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Senior Director, CMC Development Lead
1 month ago
Reston, Virginia, United States Fraser Dove International Full timeJob Summary:Fraser Dove International is seeking an experienced Senior Director, CMC Development Lead to oversee the development and manufacturing of radiopharmaceutical products. As a key member of our team, you will be responsible for leading cross-functional teams to drive the development of novel PET radiopharmaceuticals, ensuring compliance with global...
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Senior Technical Writer
3 days ago
Reston, Virginia, United States StaffChase Full timeJob Title: Technical WriterLocation: Irving, TX 75063, Jacksonville, FL, Tampa, FL 33610Job DescriptionAt StaffChase, we're building a new team within Technology Controls focused on transforming and deploying Risk & Control Self-Assessment across all of Technology. We're seeking a skilled Technical Writer to join our team and help us create value as a source...
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Senior Manager of Quality Control
3 days ago
Reston, Virginia, United States Compunnel Inc. Full timeJob Title: Senior Manager of Quality ControlJob Summary:We are seeking a highly skilled Senior Manager of Quality Control to join our team at Compunnel Inc. This is a unique opportunity to advance your career in public accounting and work with a team of highly professional and dedicated individuals.Key Responsibilities:Act as a liaison to the Director of...
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Electrical Engineer
4 weeks ago
Reston, Virginia, United States CMC Full time{"Electrical Engineer Job DescriptionAt CMC, we're seeking an experienced Electrical Engineer to join our team. As an Electrical Engineer, you will be responsible for designing, sizing, and implementing low and medium voltage power systems. You will ensure that installations and applications are in line with governing codes, including NEC and NFPA.Key...
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Senior Proposal Writer
4 days ago
Reston, Virginia, United States Demo - Maximus Full timeJob SummaryWe are seeking a highly skilled Senior Proposal Writer to join our team at Maximus. As a key member of our proposal development team, you will be responsible for creating high-quality, compliant, and compelling responses to Requests for Proposals, Requests for Information, and other government requests.Essential Duties and Responsibilities:Develop...
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Senior Technical Writer/Solutions Developer
3 weeks ago
Reston, Virginia, United States MAG Aerospace Full timeJob Title: Senior Technical Writer/Solutions DeveloperThe Senior Technical Writer/Solutions Developer is a key member of our team at MAG Aerospace, responsible for creating high-quality technical content that meets the needs of our clients. This role requires a strong understanding of technical concepts and the ability to communicate complex ideas in a clear...
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Senior Technical Writer
3 days ago
Reston, Virginia, United States Cypress HCM Full timeTechnical Writer OpportunityAbout the Role:We are seeking a skilled Technical Writer to join our team and contribute to the creation of high-quality product documentation for our industry-leading Data Cloud.As a Technical Writer, you will work closely with our world-class team of engineers and architects to develop comprehensive documentation that meets the...