- Repligen (Waltham, MA)
- …QMS, PLM, MES, etc.).Ensure technology solutions comply with GMP (Good Manufacturing Processes) and other regulatory requirements.Partner with process owners ... global , matrixed environment.EducationBachelor's degree required.Master's degree in Computer Science , Engineering, or related discipline preferred.What Repligen OffersOur mission… more
- Syner-G BioPharma Group (Boston, MA)
- … engineering, process development, materials & engineering sciences , technology transfer, facilities/utilities/technical services, and manufacturing ... specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing … more
- Olympus Corporation of the Americas (Westborough, MA)
- …Software as a Medical Device. + Demonstrated leadership in managing the global submission process for regulatory approvals across multiple markets. + ... the Digital Unit (DU). The DU is a high-growth, global innovation hub, focused on how digital technologies and...**Required:** + BS or comparable in engineering or life sciences required. + Minimum of 10 years of Regulatory… more
- Syner-G BioPharma Group (Boston, MA)
- COMPANY DESCRIPTION: Syner-G is a science -led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development ... post-market, along with operational strategy and support. With a global team of 400 employees across North America and...their journey to market. We are a leading life sciences consultancy committed to advancing human health by helping… more
- Curia (Hopkinton, MA)
- Research Scientist II; Process Development Science in Hopkinton, MA Build your future at Curia, where our work has the power to save lives The Research Scientist ... II, Downstream Process Development Science will be responsible for...clients and colleagues via technical reports. Curia is a global contract development and manufacturing organization (CDMO)… more
- Olympus Corporation of the Americas (Westborough, MA)
- …supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance ... of employee QMS awareness knowledge and application; lead quality sub-system process improvement projects to increase efficiency of the QMS through enhancing… more
- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... OperationsProvide technical troubleshooting support during customer qualification, validation and manufacturing runsApplication and Analytical ExpertiseProvide application expertise to internal… more
- Merck & Co. (Boston, MA)
- …and strategic venture investments in healthcare as part of our Global Health Innovation fund. Together, we identify business critical opportunities, frame ... patient impactBring to bear experience in oncology (across discovery, translational sciences , development and commercialization) to identify capability gaps and ways… more
- ACROBiosystems Inc. (Boston, MA)
- ACROBiosystems is a worldwide leader in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical ... in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate...aim to be a cornerstone company in the life science and healthcare industry. We value the fast growth… more
- Curia (Hopkinton, MA)
- …at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of ... development programs. In addition, the individual will collaborate closely with internal process development, manufacturing , and quality groups as well as… more
- Ralliant (Boxborough, MA)
- …problems in motion control. We serve critical markets in Life Science & Diagnostics including Cancer Research, Genomic Sequencing, Virus Surveillance, and ... better understanding and drive success. Qualifications: + 5+ years' industrial manufacturing experience, resulting in: + Technical experience and understanding +… more
- Teleflex (Chelmsford, MA)
- …of compliant manufacturing processes. This role contributes to product and process quality throughout the product lifecycle, with emphasis on process ... 10% **Requisition ID** :12983 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by...(FMEA, Gage R&R, basic DOE). - Basic understanding of manufacturing controls and process validation. - Ability… more
- CSL Behring (Waltham, MA)
- …experience in government, public affairs or communications in Pharmaceutical or life sciences company. + Experienced Corporate Affairs professional operating in a ... global environment + Understanding of corporate social responsibility principles...the public policy landscape, with particular relevance to industry, manufacturing and/or the biotech and medicines sector Competencies +… more
- Parexel (Boston, MA)
- …opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role ... small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **About the role** This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject matter ... manufacturing strategies, applying deep drug substance expertise and direct manufacturing experience to support process design, scale-up, technology transfer,… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About ... As a Process Scientist (Associate Director) - Global Manufacturing Science GMSci Drug...successful collaboration with: + Pharmaceutical Sciences . + Manufacturing Sciences + Global … more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **About the role** Join us as our ** Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility ... process technology. In this role, you will lead cross‑functional CMC teams, represent Global Manufacturing Sciences (GMSci) in global product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Global Manufacturing Sciences BioProcess Lead (Sr. Manager)** **Location: ... Switzerland / Lexington, MA** **About the role:** As a Global Manufacturing Sciences Bioprocess Lead,...span products, sites, and functions. + Partner with site Manufacturing Sciences (MS) teams on process… more
- Takeda Pharmaceuticals (Lexington, MA)
- By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application ... as our **CMC Sr. Project Lead** , **_Global Biologics Manufacturing Sciences_** _(GMsci Bio)_ and play a pivotal role...guide CMC teams with the CMC lead. + Lead Global Technology Transfer Projects + Ensure timely execution of… more
- Takeda Pharmaceuticals (Boston, MA)
- … of new innovative medicines for our patients around the world through robust CMC processes. Global Manufacturing Science is a part of Global ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
