JobotNewDirector of Engineering, Building Design JobotDirector of Engineering, Building DesignBoston, MA$160,000–$200,000 / yearNational Building Design Engineering firm looking for an executive level engineering manager to help drive business development in the commercial, healthcare and higher education space along with manage day to day operations. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
Kforce Inc.Public Accounting (Tax w/ Audit) Director Level Kforce Inc.Public Accounting (Tax w/ Audit) Director LevelBoston, MA$160,000–$250,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This role offers the opportunity to work directly with senior leadership while advising a diverse client base of closely held businesses and high-net-worth individuals.
Global Arts LiveNewStagehand Global Arts LiveStagehandCambridge, MAFull timeWorking under the direction of the Technical Director and department heads, the Stagehand supports load-ins, performances, and load-outs across a variety of productions including music concerts, dance, and special events. This position requires the ability to lift and carry equipment up to 50 lbs, work at heights (catwalks, ladders, lifts), stand or walk for extended periods, and work in variable lighting and sound environments.
Cox CommunicationsEnterprise Solutions Director - Strategic Pursuits (RapidScale) Cox CommunicationsEnterprise Solutions Director - Strategic Pursuits (RapidScale)Boston, MA$148,500–$247,500This role partners closely with strategic Account Executives / Dealmakers to shape, qualify, and win RapidScale's largest and most complex opportunities-typically involving multi-year managed services, hybrid cloud transformations, carve-outs, divestitures, and Walk-In Takeovers (WITO). Role Overview: The Solution Director - Strategic Enterprise Pursuits is the senior authority responsible for owning complex enterprise solutions as commercially viable, operationally executable, and outcome-driven business constructs.
Dialysis Clinic, Inc.Dialysis Area Equipment Technical Manager Dialysis Clinic, Inc.Dialysis Area Equipment Technical ManagerSomerville, MA$100,000–$120,000 / yearDCI’s Differentiator:Since opening the first clinic 50 years ago in Nashville, Tenn., our Dialysis Clinic, Inc. family has grown to be the nation’s largest nonprofit dialysis provider with more than 270 locations in 30 states, serving nearly 14,000 patients each day. We empower patients to live meaningful and productive lives while also delivering high quality kidney care, saving lives and reducing hospitalizations.
Michael Page USADirector, Strategic Partnerships, CMC - CDMO Michael Page USADirector, Strategic Partnerships, CMC - CDMOCambridge, MARemote$170,000–$200,000 / yearFull timeThe business is world-renowned for small molecules discovery, development, and manufacturing services and works with all major Big Pharma businesses. Identify and grow opportunities within existing accounts while developing new client relationships across small molecule services.
Lahey Hospital and Medical CenterUltrasound Imaging Technical Director: BIDMC, (Multi- Modality) Lahey Hospital and Medical CenterUltrasound Imaging Technical Director: BIDMC, (Multi- Modality)Boston, MA$160,000–$180,000 / yearProblem 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. 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.
Beth Israel Lahey HealthNewInterventional Radiology Technical Director, Radiology (Multi-Modality) Beth Israel Lahey HealthInterventional Radiology Technical Director, Radiology (Multi-Modality)Boston, MassachusettsRepresents 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. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.
Public Schools of BrooklineNewProduction Stagecraft & Design Teacher (0.5 FTE) / Performing Arts Technical Director & Educator (0.4 FTE) Public Schools of BrooklineProduction Stagecraft & Design Teacher (0.5 FTE) / Performing Arts Technical Director & Educator (0.4 FTE)Brookline, MAWe are seeking a passionate educator and performing arts professional who is committed to providing high-quality instruction, fostering student creativity and leadership, and supporting a vibrant performing arts community that serves nearly 1,000 students annually. The Performing Arts Tech Educator supports the technical, production, and operational needs of the Brookline High School Performing Arts Department while helping students develop technical theater and production skills.
St. Mark's SchoolTechnical Director (Part-Time) St. Mark's SchoolTechnical Director (Part-Time)Southborough, MA$3,500–$5,500The Technical Director plays a vital role in mentoring students while helping bring productions to life in ways that are safe, thoughtful, and artistically compelling. Theater productions at St. Mark's are collaborative, student-centered experiences that encourage creativity, teamwork, problem-solving, and confidence both onstage and behind the scenes.
Swedish Orphan Biovitrum ABCMC / Technical Operations Program Manager - Associate Director Swedish Orphan Biovitrum ABCMC / Technical Operations Program Manager - Associate DirectorWaltham, MA$153,000–$211,000 / yearProject manage all key CMC deliverables, incl underlaying reports, coordinate team interactions ensuring team meetings have structure and purpose, documents clear decisions/actions and communicates them to team members and relevant stakeholders, holds team members accountable for functional delivery of plans. > 8 years of pharmaceutical industry experience, there of: Significant hands-on experience in CMC Development and Program/ Project Management roles in complex environments and experience in working with cross-functional teams in the pharmaceutical industry, preferably in a global setting.
Snowflake IncSr. Technical Delivery Director Snowflake IncSr. Technical Delivery DirectorBoston, MA$245,000–$321,300 / yearCollaborate with Sales Account Teams, Services Delivery Sales Teams, Services Delivery Leadership, Resource Management Teams, and SI/ Partners to understand the customer and engagement needs, including business & technical challenges, key stakeholders, and delivering on the value of Snowflake. Lead the Technical Delivery Team through large complex engagements, engaging at executive and sponsor levels both on the customer and partner sides, and acting as the escalation point of contact to facilitate collaboration, decision making, internal alignment, and customer buy-in on proposed solutions.
Citrin Cooperman & Company LLPDirector, Technical Product Owner/App Development Leader (50356) Citrin Cooperman & Company LLPDirector, Technical Product Owner/App Development Leader (50356)Braintree, MAWe're continuously seeking talented individuals who bring fresh perspectives, a problem-solving mindset, and sharp technical expertise. Responsibilities are, but not limited to: • Process regularly delivering features in an agile way, delivering against the strategic priorities and business outcomes of the service line.
Kiniksa PharmaceuticalsNewAssociate Director, Technical Writing Kiniksa PharmaceuticalsAssociate Director, Technical WritingLexington, MassachusettsWith deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Responsibilities (including, but not limited to): Lead planning and development of technical and scientific documents, including technical reports, protocols, summaries, presentations, and cross-functional deliverables.
Motional IncDirector of Technical Program Management Motional IncDirector of Technical Program ManagementBoston, MA$212,000–$291,500 / yearPartner with engineering leadership team on OKR planning, drive decomposition of objectives into quarterly goals and program plans with cross-functional teams, and lead technical and planning reviews to track and manage progress. We aren''t just developing driverless cars; we''re creating safer roadways, more equitable transportation options, and making our communities better places to live, work, and connect.
AECOMEngineering Technical Director - Conveyance Systems AECOMEngineering Technical Director - Conveyance SystemsBoston, MA$150,000–$200,000 / yearWe invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world. **ReqID:** J10150103 **Business Line:** Water **Business Group:** DCS **Strategic Business Unit:** East **Career Area:** Engineering **Work Location Model:** Hybrid **Compensation:** USD 150000 - USD 200000 - yearly
The Vascular Care GroupTechnical Director of Ultrasound The Vascular Care GroupTechnical Director of UltrasoundLowell, MALead education efforts to ensure staff are well educated with respect to the latest care pathways, technologies, and advanced vascular care knowledge. Work with leadership to identify and vet strategic expansion and development of vascular lab services and locations.
Danvers Public SchoolsExtracurricular Technical Theater Director (Middle and High School) Danvers Public SchoolsExtracurricular Technical Theater Director (Middle and High School)Danvers, MAJob Title: Extracurricular Technical Theater Director (Middle and High School) Position Type: Extracurricular Stipend Location: Danvers High School Reports To: Performing Arts Coordinator Compensation: In accordance with co-curricular stipends of teacher contract Position Overview The Technical Director (TD) serves as a key member of the production staff for the Performing Arts Department and is responsible for overseeing the technical execution of multiple theatrical productions throughout the school year. These productions include: High School Fall Musical Middle School Winter Musical High School Dramafest Play Middle School Dramafest Play High School Spring Production The Technical Director oversees scenic construction, technical implementation, and backstage operations for each production.
Vertex Pharmaceuticals IncSenior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid) Vertex Pharmaceuticals IncSenior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid)Boston, MAPrepare, maintain and manage to budget allocation.\n \nRequired Education Level\n\n Bachelor's degree or Master's degree in a biotech/technical life science/engineering discipline.\n \nRequired Experience\n\n Typically requires 15+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment\n A minimum of 10 years leadership experience leading teams or directing allocation of resources. Previous experience on a Site Leadership Team and/or Quality Leadership Team\n \nRequired Knowledge/Skills\n\n In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).\n Quality experience of on-site manufacturing as well as CDMO oversight.\n In depth experience in all stages of clinical development to commercialization product life cycle management.\n
Beacon Therapeutics (USA) IncNewExecutive Director, Technical Operations and Development - REMOTE East Coast Based Beacon Therapeutics (USA) IncExecutive Director, Technical Operations and Development - REMOTE East Coast BasedCambridge, MARemote$240,000–$270,000 / yearAs Executive Director, Technical Operations and Development, you will strengthen CMC execution for late-stage gene therapy programs, ensuring activities land on schedule, issues are driven to closure, and stakeholders remain aligned across internal teams and external partners. Working fully remote on an Eastern schedule (Mon–Fri, 8am–5pm), you’ll balance deep technical context with pragmatic delivery, keeping late-stage activities progressing without unnecessary friction.
Vertex Pharmaceuticals IncManufacturing Process & Technical Quality Associate Director, CGT Vertex Pharmaceuticals IncManufacturing Process & Technical Quality Associate Director, CGTBoston, MA$156,600–$234,800 / yearServe as the Quality SME on the Chemistry, Manufacturing, and Controls (CMC) Governance teams covering Process Development, Technical Operations, and Supply Chain topics for technical transfers, new product introduction across a product life cycle to assure a compliant strategy is developed, executed and maintained. General Summary: The Manufacturing Process & Technical Quality Associate Director is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities.
Tenable Network SecuritySenior Director, Ecosystem & Solution Architectures - Technical Alliances Tenable Network SecuritySenior Director, Ecosystem & Solution Architectures - Technical AlliancesBoston, MA$202,000–$269,333.33 / yearProcess & 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 Tenables 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.
Danaher CorpDirector of Commercial and Technical Program Management (Bioprocessing, Medical Device, Pharmaceutical) Danaher CorpDirector of Commercial and Technical Program Management (Bioprocessing, Medical Device, Pharmaceutical)Marlborough, MAPartnering closely with Product Management and Commercial leaders, this role translates BU strategy into cross‑functional programs, oversees Growth Room governance, and drives progress against growth objectives through structured performance management and strong team leadership. The Director of Commercial and Technical Program Management leads Business Unit commercialization and Launch Excellence (LEx) programs to ensure launch readiness and consistent execution for priority platforms.
Alvarez & Marsal Holdings LLCNewDirector, PEPI - Technology Services CTO Domain Alvarez & Marsal Holdings LLCDirector, PEPI - Technology Services CTO DomainBoston, MAThis role requires a practitioner who has operated inside or directly alongside engineering and product organizations-someone who has personally led SDLC transformations, managed engineering teams, governed AI coding tool rollouts, or run DevOps programs at scale-and who can translate that hands-on operating experience into rapid, credible impact within the compressed timelines of a PE holding period. Govern LLMOps at enterprise scale: RAG pipeline architecture and optimization (chunking strategies, embedding models, vector database selection-Pinecone, Weaviate, Qdrant, pgvector), prompt versioning, evaluation frameworks (RAGAS, LangSmith, Phoenix), and inference cost governance.
Capital One Financial CorpDirector, Technical Program Management Capital One Financial CorpDirector, Technical Program ManagementCambridge, MA$230,400–$263,000 / year3+ years years experience delivering large and complex programs - where you own the business or technical vision, collaborate with large cross-functional teams, secure commitments on deliverables and unblock teams to land business impact. Our TPM Directors have: Strong technical backgrounds (ideally building highly scalable platforms, products, or services) with the ability to proactively identify and mitigate technical risks throughout delivery life-cycle.
Publicis Groupe SAGTM Technical Solutions Director, Salesforce Publicis Groupe SAGTM Technical Solutions Director, SalesforceBoston, MALead the end-to-end technical pre-sales process across priority deal types, including scoping, estimation, and solution proposal development Partner directly with customers to understand business goals, shape solution strategy, and build confidence through engaging, influential interactions Design innovative, practical Salesforce-based solutions that align client needs with delivery capabilities Collaborate with specialist teams to create differentiated solution plays, demos, and reusable accelerators Serve as a trusted technical counterpart to sales, helping improve win rates, reduce cycle time, and protect delivery margins Represent the Salesforce practice as a thought leader with clients, Salesforce counterparts, and the broader ecosystem Contribute to GTM strategy, value propositions, and innovation initiatives across the practice Measures of Success: Improved win rate and reduced pursuit cost across engaged deal types. Start to lead customer-facing scoping and estimation for priority pursuits Begin to Develop and refine AI-enabled solution packages Author proposals and client-facing deliverables Advise on staffing models and delivery feasibility Start working on existing and new opportunities as a dynamic technical counterpart to the Sales team and a trusted presence with customers.
Beam TherapeuticsAssociate Director, Quality Control Technical Services Beam TherapeuticsAssociate Director, Quality Control Technical ServicesCambridge, MA$185,000–$225,000 / yearThe 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). In addition, this position will contribute directly to regulatory filings, including specifications, analytical method validation reports, and CMC documentation, and will serve as a QC technical subject matter expert across program teams to ensure compliant, robust, and phase‑appropriate analytical strategies.
Kailera TherapeuticsNewAssociate Director, SEC Reporting & Technical Accounting Kailera TherapeuticsAssociate Director, SEC Reporting & Technical AccountingWaltham, MassachusettsServe as the primary point of contact for all aspects of the Company’s SOX compliance program, including ownership of risk assessment, scoping, documentation, testing coordination, remediation of control deficiencies, and ongoing communication with internal stakeholders and external auditors to ensure effective internal controls over financial reporting. This role will report directly to the Vice President, Corporate Controller and be responsible for providing technical expertise and support for the SEC filing, compliance related reporting, internal controls compliance program, and technical accounting functions for a company that recently closed an IPO.
The Bank of New York Mellon CorpNewSenior Director, Technical Product Manager - Digital Assets The Bank of New York Mellon CorpSenior Director, Technical Product Manager - Digital AssetsBoston, MA$136,500–$300,000 / yearIn this role, you'll make an impact in the following ways: Drive delivery for key Digital Asset Custody capabilities (wallet services, key management, and operating workflows) by translating outcomes into clear requirements and a prioritized backlog. Contribute to custody security and control design by capturing control requirements in stories, partnering on threat/risk reviews, and supporting evidence collection for audits (e.g., MPC/HSM usage, access governance, segregation of duties).
Lahey Hospital and Medical CenterInterventional Radiology Technical Director, Radiology (Multi-Modality) Lahey Hospital and Medical CenterInterventional Radiology Technical Director, Radiology (Multi-Modality)Boston, MA$160,000–$180,000 / yearProblem 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.
Wayfair LLCAssociate Director, Technical Program Management Wayfair LLCAssociate Director, Technical Program ManagementBoston, MAIn this role, you will define and own the Technical Program Strategy for some of our most complex Business Initiatives - aligning technical execution with business outcomes, enabling cross-organizational delivery excellence, and serving as a thought leader for technical planning, risk mitigation, and operational governance. Were hiring an Associate Director of Technical Program Management to drive large-scale, high-impact strategic technology initiatives that span multiple platforms, systems, and functions across Wayfair.
Vertex PharmaceuticalsNewAssociate Director, QA Manufacturing Technical Services Vertex PharmaceuticalsAssociate Director, QA Manufacturing Technical ServicesBoston, MassachusettsProvide 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 role is also responsible for building strong partnerships with internal cross-functional teams to drive compliance, monitor performance, support continuous improvement, and provide quality presence and real-time support on the manufacturing floor.
Wayland Public SchoolsWMS Fall Play Technical Theater Director - Afterschool Wayland Public SchoolsWMS Fall Play Technical Theater Director - AfterschoolWayland, MAWPS is proudly a member district of the Massachusetts Partnership for Diversity in Education dedicated to creating an inclusive, supportive and equitable educational community. Be proficient in the basics of carpentry and set construction; schedule set builds and technical rehearsals in conjunction with the Stage Director.
Danaher CorpSenior Director, Human Resources, Cell Culture Media & CTO Danaher CorpSenior Director, Human Resources, Cell Culture Media & CTOMarlborough, MAShape 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. Run integrated talent processes (succession planning, performance management, leadership development) in partnership with regional HR Business Partners and HR Centres of Excellence; enable cross‑functional talent moves.
WayfairAssociate Director, Technical Program Management WayfairAssociate Director, Technical Program ManagementBoston, MAIn this role, you will define and own the Technical Program Strategy for some of our most complex Business Initiatives — aligning technical execution with business outcomes, enabling cross-organizational delivery excellence, and serving as a thought leader for technical planning, risk mitigation, and operational governance. We’re hiring an Associate Director of Technical Program Management to drive large-scale, high-impact strategic technology initiatives that span multiple platforms, systems, and functions across Wayfair.
Tenable IncSenior Director, Ecosystem & Solution Architectures - Technical Alliances Tenable IncSenior Director, Ecosystem & Solution Architectures - Technical AlliancesBoston, MA$202,000–$269,333.33 / yearProcess & 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.
Wave Life Sciences LtdAssociate Director, Drug Product Technical Services (DPTS) Wave Life Sciences LtdAssociate Director, Drug Product Technical Services (DPTS)Lexington, MA$163,000–$221,000 / yearOur 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.
Guidehouse IncAssociate Director - Transmission & Distribution (T&D) Technical Services Guidehouse IncAssociate Director - Transmission & Distribution (T&D) Technical ServicesBoston, MA$122,000–$203,000 / yearAssociate 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.
Beacon Therapeutics (USA)NewExecutive Director, Technical Operations and Development - REMOTE East Coast Based Beacon Therapeutics (USA)Executive Director, Technical Operations and Development - REMOTE East Coast BasedCambridge, MARemote$240,000–$270,000 / yearAs Executive Director, Technical Operations and Development, you will strengthen CMC execution for late-stage gene therapy programs, ensuring activities land on schedule, issues are driven to closure, and stakeholders remain aligned across internal teams and external partners. Working fully remote on an Eastern schedule (Mon–Fri, 8am–5pm), you'll balance deep technical context with pragmatic delivery, keeping late-stage activities progressing without unnecessary friction.
Beam Therapeutics IncAssociate Director, Quality Control Technical Services Beam Therapeutics IncAssociate Director, Quality Control Technical ServicesCambridge, MA$185,000–$225,000 / yearThe 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.
Bose ProfessionalDirector of Technical Solutions, Americas Bose ProfessionalDirector of Technical Solutions, AmericasOpen to MA, TX or TN, MARemoteFull timeCreate 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 .
Avalyn PharmaAssociate Director, SEC Reporting & Technical Accounting Avalyn PharmaAssociate Director, SEC Reporting & Technical AccountingBoston, MA$166,000–$186,000 / yearAP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Support commercialization readiness by helping establish GAAP- and SOX-compliant revenue accounting and order-to-cash processes in partnership with Commercial, Market Access, Finance, and IT.
Alkermes PlcAssociate Director, Data Analytics and Technical Solutions Alkermes PlcAssociate Director, Data Analytics and Technical SolutionsWaltham, MAIn 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. This position will bridge the gap between complex clinical data sources and actionable business intelligence metrics utilized by Clinical Operations, Data Management and Clinical Programming departments within the Clinical Development Operations organization.
Ionis Pharmaceuticals IncAssociate Director, CMC Technical Services Ionis Pharmaceuticals IncAssociate Director, CMC Technical ServicesBoston, MAD. 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.