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Regulatory Cmc Jobs in Texas

Sr. Director Of Cmc
By EPM Scientific At Greater Boston, United States
Past Management Experience is a MUST
Will work and manage in-house and outsourced lab activities
Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality
Experience overseeing outsourced vendors (CMOs/CDMOs)
Experience overlooking multiple drug candidates within the company's pipelines
M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience
Associate Director Of Drug Product Cmc
By EPM Scientific At Greater Boston, United States
• Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
• Extensive experience from Discovery, Pre-formulation, Formulation to Commercialization
• Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
• Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) – highly coveted
• Experience authoring CMC sections for IND, BLA & MAA is highly sought after
Associate Director/Director - Formulations(Drug Product)
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.
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: