- Takeda Pharmaceuticals (Boston, MA)
- …as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions + ... business partner leadership role. + Proven track record in delivering enterprise-scale CMC technologies and digital solutions in a GxP-regulated environment. + Deep… more
- Takeda Pharmaceuticals (Boston, MA)
- …of evolving international regulatory requirements (eg, IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/ CMC , CTIS, ESMP) and assess their impact on RIM data. **3. Collaboration ... concepts into business terms. + Experience with regulatory domains such as Labeling, CMC , and broader Regulatory Affairs processes. + Exposure to public and hybrid… more
- Takeda Pharmaceuticals (Boston, MA)
- …also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible filing ... unit leaders + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge is captured, shared, and reused across… more
- Takeda Pharmaceuticals (Lexington, MA)
- …provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. You will ensure that complex, ... translate development knowledge into commercial robustness. + Shape and align CMC content for multi-site products, including authoring and reviewing regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …recommend contingency plans as required. + Evaluates impact of decisions across CMC functions. + Makes significant independent contributions to complex pipeline or ... Proactively analyses manufacturing issues and coordinates potential solutions with the CMC team. Assists in the technical aspects of negotiation with vendors.… more
- Takeda Pharmaceuticals (Boston, MA)
- …& Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering ... AI/ML, NLP) into the product portfolio to drive operational excellence and innovation in CMC and device design + Ensure all products are developed and maintained in… more
- Amgen (Cambridge, MA)
- …analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs. + ... (templates, QC checks, method trending) and ensure traceability and data integrity for CMC deliverables. **What we expect of you** We are all different, yet we… more
- Alloy Therapeutics (Waltham, MA)
- …to join our growing Nucleic Acid Chemistry team supporting the CMC development of oligonucleotides, mRNA, pDNA templates, and antibody-oligonucleotide conjugates ... optimize, document, qualify, and transfer phase-appropriate analytical methods to support CMC activities for oligonucleotides, mRNA, pDNA, and AOCs. + Design… more
- GE Aerospace (Lynn, MA)
- …company objectives related to the successful execution of Ceramic Matrix Composites ( CMC ) component design across all Defense and Systems programs. In this role, ... you will lead the CMC design engineering team with 8+ direct reports. You will be responsible for activities contributing to the design and development of products,… more
- Bristol Myers Squibb (Devens, MA)
- …T he individual will provide technical expertise and leadership to Product CMC /Quality Teams to develop, implement, and manage the strategies for Quality to ... functions. + Supports the overall product quality strategy based on CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments.… more
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