div>Provide quality and technical expertise in the investigation of deviations including OOS/OOTs, conduct thorough root cause analysis to identify underlying issues, and oversee efficient and effective implementation of corrective and preventive actions (CAPA) to prevent recurrence.
The Associate Director, Quality Assurance Manufacturing Technical Services (Internal) is responsible for supporting the day-to-day Quality Operations for internal manufacturing of Cell & Gene Programs through the management of quality management system (QMS) events.
p>Problem Solving: Ability to address problems that are broad, complex and abstract, often involving Medical Center-wide issues and requiring substantial creativity, resourcefulness, staff engagement, Lean diagnostic techniques, negotiation and diplomacy to develop solutions. Essential Responsibilities:
Represents the division on all technical leadership initiatives; including maintaining relationships with other managers to develop and coordinate department wide initiatives, acts as the primary representative of the division when interfacing with hospital department, physicians and nursing.
Marlborough, Massachusetts3 days ago
Shape and execute short‑ and long‑term people strategies (organization design, Leadership Development, Global Project Management, Workforce planning, Executive coaching, Policy & Governance, talent, culture, inclusion & belonging) and provide leadership to global and local HR teams supporting the business. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.
Cambridge, MA30+ days ago
p>The successful candidate will work cross-functionally with Analytical Research & Development, Bioprocess Development, Manufacturing Technical Services, Manufacturing Operations, Regulatory Affairs, and Quality Assurance to drive the transfer, qualification, validation, and lifecycle management of analytical methods for gene-edited cell therapy products and associated critical materials (e.g., mRNA). Primary Responsibilities:
- Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization.
Create and guide technical content that translates product features into clear business value, application benefits, system outcomes, decision-making confidence, and competitive advantages, including short-form videos, webinars, technical explainers, design guidance, FAQs, demo scripts, launch support content, and technical playbooks . Partner with sales leadership to support strategic opportunities, top accounts, rep firms, consultants, and key channel partners through system design guidance, product application support, competitive positioning, demonstrations, proof-of-concept activity, and technical validation .
Lexington, MA30+ days ago
Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Description:
The Associate Director of DPTS leads drug product (DP) validation activities for Waves injectable assets in Phase 1-3 clinical trials and authoring of documents required for Regulatory submissions.
li>Process & Escalation: Define and enforce clear, compliant escalation processes, acting as the exclusive point of contact for external technical vendors to prevent unauthorized direct communication with Tenable customers or other internal teams. The role requires deep technical knowledge across Tenable's product suite and a proven ability to lead intricate, cross-functional projects with a focus on both strategic product-market fit and hands-on technical execution.
em> Associate Director-Bachelor's degree in electrical or power systems engineering from an accredited university or college AND Seven (7+) plus years post-graduation work experience in the Utilities industry; Or Master's degree in electrical or power systems engineering from an accredited university or college AND Five (5+) plus year post-graduation work experience in the Utilities industry; Or PhD in electrical or power systems engineering from an accredited university or college AND Three (3+) plus year post-doctoral work experience in the Utilities industry. Working knowledge of ISO/RTO operations and functions, especially western markets and CAISO Knowledge of resource interconnection and expansion planning practices and protocols Familiarity with transmission development, including competitive development Ability to code and knowledge of coding languages such as R, Python, VA, SQL #LI-RE1 The annual salary range for this position is $122,000.00-$203,000.00.
D. plus at least 5 years of relevant cGMP drug product manufacturing experience with at least 5 years of pharmaceutical industry experience overall • Working knowledge of cross-functional drug development processes, FDA/ICH/EMA/ISO guidelines and cGMPs • Knowledge of cGMP, contracts, supply agreements, and quality systems as it relates to Contract Manufacturing Organizations • Full understanding of complex technical issues in drug product fill/finish manufacturing and packaging • Prior experience with oligonucleotide manufacturing is a plus • Prior experience with SAP or other ERP systems are a plus • Experience in orphan/rare disease commercialization is a plus • Hands on experience with commercial drug product fill / finish manufacturing • Hands on experience with commercial drug product global packaging and assembly requirements • Understanding of Release testing and experience with drug product stability requirements • Experience in interactively working with CMO's and CMO relationship building • Strong communication and presentation skills and business partnering ability • Strategic, analytical and results-driven thinker with the ability to plan and direct • Resourceful and creative problem solver • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment • Problem solving ability related to cGMP manufacturing, technical and regulatory • Strong interpersonal skills and ability to work with internal and external stakeholders in a positive, collaborative manner • Ability to travel (~15-25%) in the US and internationally. • Present as "Person-in-Plant" as needed during commercial drug product manufacturing runs • Lead the CMO relationships for manufacture of commercial drug product, assembly, and/ or packaging • Work closely with the quality team to ensure timely release of commercial drug product • Provide CMC support, as needed, for regulatory filings including new marketing authorization applications and questions from health authorities • Coordinate vendor submission aspects of annual product updates to regulatory filings • Work with Supply Chain and QA to measure CMO performance through implementation and trending of key performance indicators (KPIs) • Generate improvement plans as needed • Contribute to the review, with Quality, of manufacturing documents, including MBRs, specifications, change controls, and deviations • Ensure that client approval of all CMO documents is provided in a timely and efficient manner • Provide CMC input and support for commercially relevant topics to development program teams • Determine path forward for optimization of drug supply, including manufacturing, QC testing and QA release strategy for all commercial markets • Work with Ionis team to evaluate vendor capabilities of new CMOs or test laboratories.