We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD) at Boehringer Ingelheim. The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations. div style="text-align:justify">Analytical Expertise - Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer and lifecycle management.
Required Skills: - Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations.
This position requires strong Technical Writing skills using MS Word and attention to detail. The successful candidate will be responsible for updating client policies and procedures using MS Word. p>In addition, we're looking for a few key technical requirements that will help you excel: experience with Linux systems and the command-line interface; experience with container technologies using Docker and Kubernetes; application delivery networking and related concepts; and/or service provider networking; understanding of web technologies (e.g., HTTP, REST, JSON); and. F5 maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, geographic locations, and market conditions, as well as to reflect F5's differing products, industries, and lines of business.
North Haven, CT16 days ago strong>Responsibilities may include the following and other duties may be assigned:- Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision. Primary Talent Partners has a new contract opening for a Medical Device Technical Writer with our medical device client in North Haven, CT.
As a trusted partner, we provide actionable solutions and innovation through our Aerospace Technologies, Building Automation, Energy and Sustainability Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable. We are a leading software-industrial company committed to introducing state-of-the-art technology solutions to improve efficiency, productivity, sustainability, and safety in high-growth businesses in broad-based, attractive industrial end markets. Technical Writer ASM Research, An Accenture Federal Services CompanyTechnical WriterHartford, CT30+ days ago Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. This role collaborates closely with engineers, analysts, process and practice owners, service owners, the ITIL Specialist, and the Service and Integration Management Lead to translate complex technical, operational, and security-related information into accessible content. Ridgefield, CT15 days ago The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations. This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and technical writing capabilities to support documentation and global regulatory submissions (e. North Haven, CT16 days ago p>Location: North Haven, CT (Onsite 4 days/week, 1 day remote). Incorporate feedback from Regulatory, Quality, Engineering, and Marketing teams. At ASSA ABLOY, our global teams collaborate seamlessly to craft products and services that integrate into our users' lives, simplifying their everyday routines and enhancing convenience. This role will support our ground-breaking electromechanical and electronic access control (EM/EAC) solutions by translating complex product information into clear, engaging, and customer-centric documentation. Ridgefield, CT30+ days ago Description: We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD) at Boehringer Ingelheim. The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations. Applicant will work closely and coordinate with multiple engineering disciplines, technical illustrators, and department supervision to develop new or revised descriptive chapters, operating procedures, maintenance procedures, and component technical manuals for systems and equipment found onboard nuclear-powered submarines. A Technical Writer will develop technical products in interactive electronic Technical Manual (IETM) format using state of the art electronic publishing software. Our mission relies on expert analysis and bold ideas to deliver actionable, objective business and technology insights, helping enterprise leaders and their teams succeed with their mission-critical priorities. Youll have access to unmatched resources, expertise, and technology, and play a key role in helping Gartner and our clients innovate and grow as we leverage AI to transform business and technology landscapes. Applicant will work closely and coordinate with multiple engineering disciplines, technical illustrators, and department supervision to develop new or revised descriptive chapters, operating procedures, maintenance procedures, and component technical manuals for systems and equipment found onboard nuclear-powered submarines. A Technical Writer will develop technical products in interactive electronic Technical Manual (IETM) format using state of the art electronic publishing software. Description: Duties and ResponsibilitiesTranslate technical concepts into clear concise and user-friendly documentationCreate and deliver technical materials for less complex products occasionally managing multiple tasks concurrentlyCollaborate with cross-functional teams to ensure content accuracy alignment and consistencyWork closely with multiple engineering disciplines to understand product features requirements and use casesRevise update and rewrite existing technical documentation to reflect product or process changesParticipate in the engineering change management process including document creation approval routing inventory disposition and release activitiesCreate and edit graphical reference assets using Adobe Creative Cloud tools Illustrator InDesign etc. Education and ExperienceBachelors degree BABS with 02 years of relevant experience or high school diploma with 25 years of relevant experienceStrong written and verbal communication skills1 year of experience with Adobe Creative Cloud preferredProficiency with Microsoft Word Excel and TeamsExperience with Atlassian Jira or similar project management tools preferred. Rocky Hill, CT30+ days ago United States, Scottsdale, AZ, United States, Denver, CO, United States, Rocky Hill, CT, United States, Chicago, IL, United States, St. Louis, MO, United States, Reno, NV, United States, Salt Lake City, UT, Adhesive Technologies. United States, Bay Point, United States, Berkeley, United States, Culver City, United States, Irvine, United States, Los Angeles, United States, Cambridge, United States, Boston, Adhesive Technologies. Qualifications You Must Have: A Bachelor's Degree in Information Technology or related field and 8+ years of experience in Information Technology that includes experience in a customer facing role, requirement gathering, designing functional/technical solutions, and providing support, and experience in managing and delivering projects in dynamic organizations; OR Advanced Degree and 5+ years of experience in Information Technology or related field that includes experience in a customer facing role, requirement gathering, designing functional/technical solutions, and providing support, and experience in managing and delivering projects in dynamic organizations. The ideal candidate will be an experienced, highly motivated and mission-driven individual who will engage directly with the operations organization to understand customer requirements, identify, and develop solutions that meet or exceed customers' expectations. North Haven, CT14 days ago Key Responsibilities Plan, research, develop, and write medical device labeling, managing deliverables as part of cross-functional project teams under general supervision. Simultaneously manage up to two labeling updates and one small, new-product-introduction project involving multiple labeling pieces. Stamford, Connecticut14 days ago p>This hands-on BSI Manager of Technical Projects (MTP) position will reside within the Firms Business Solutions & Innovations Department (BSI) and will lead multiple project lifecycles and deliverables for the Firms most strategic and innovative business services initiatives. Collaborate with the firm's internal Revenue and Finance departments' leadership on all BSI cross-functional projects involving LMS/Rippe, Data Analytics & reporting, Aderant, Power BI, third party vendors, new software Integrations, and other initiatives. div style="text-align:justify"> Minimum Qualifications: - BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training .
- Provides supervision on the floor enforcing compliance data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc.
Additionally, the team has a strong focus on driving the supplier schedule including oversight of design documentation, test procedures, and test reports to meet all applicable requirements while identifying deficiencies in the specification to apply lessons learned to future electric propulsion plant submarine topologies. The D489 MPC team responsibilities include MPC design development/redesign efforts, qualification testing, and analysis for all systems within the component including digital signal processors (DSPs), general purpose processors, control systems, etc. li>Map the supply market for high-precision parts, qualify domestic and international suppliers, and cultivate partnerships through structured QCDU (quality, cost, delivery, utilization) reviews. At Alinabal, you will architect how we source precision components, elevate supplier quality, and steer a resilient global supply base for aerospace, defense, and other highly regulated customers. We also offer a comprehensive benefits package, which includes a range of competitive healthcare options, insurance, and disability benefits, employee stock investment program, learning resources, career development programs, reimbursement for certain education expenses, paid time off (vacation / holidays / sick / leave / parental & caregiving leave / bereavement / volunteering / floating holidays) and a motivational wellbeing program. The Head of Data Science will lead the development of a globally scalable, AI-enabled data science capability within Investment Technology Solutions (ITS), delivering advanced analytics and machine learning solutions that directly enhance investment outcomes across asset classes. |