- Repligen (Waltham, MA)
- …reporting, including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit requests ... and quarterly close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ledger accounting,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in external vendor and NNI processes to mitigate non-compliance and deviation occurrence Support internal and external stakeholders with issue resolutions in a ... a Center of Excellence (COE) for vendor quality assessment management Provides SME support to employees working within the quality control process, including… more
- Merck & Co. (Durham, NC)
- …Management System (LIMS), handle Quality Notification authoring and provide audit support . GENERAL PROFILE: Collaborate with internal customers and vendors ... individuals at all levels in the organization FUNCTIONAL EXPERTISE: The Specialist, Quality Control will be responsible for activities that support cGMP and… more
- Tris Pharma (Monmouth Junction, NJ)
- …in each other and in respectful, open and honest communications to help support individual and team success.Located in Monmouth Junction, New Jersey, Tris has an ... documentations, in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and automation models using available data Ensure effective communication with both internal and external stakeholders Support internal /external Logistics ... projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control , MSAT, and Engineering to support and...Facilities, Quality Control , MSAT, and Engineering to support and improve the planning processes across the site.… more
- Twist BioScience (South San Francisco, CA)
- …standards, development, rigorous testing, validation, deployment, and post-go-live support for new and existing biomanufacturing facilities.System Optimization & ... Support : Drive continuous improvement and feature enhancement of existing...FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system… more
- Merck & Co. (Durham, NC)
- …support of training and implementation of any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT ... of any new projects.-Provide mentorship and coaching to ensure team success.SME support during routine internal and external GMP and Financial audits,… more
- Eisai, Inc (Exton, PA)
- …Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions to support successful product ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Twist BioScience (South San Francisco, CA)
- …a hands-on position that will be responsible for maintaining the company's internal financial statements and monthly financial close process. The Sr Manager ... reconciliation process, safeguarding the integrity of our significant accounts that support our financial records and controlsConsolidation of the monthly financial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the ... organization. Internal relationships include close interactions with marketing, sales, extended...other ad hoc analyses to: proactively address issues in support of company objectives, operating model decision, mitigate decision… more
- Merck & Co. (Rahway, NJ)
- …substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in ... biologics portfolio.Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments,… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline.- Given… more
- Merck & Co. (Rahway, NJ)
- …. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serve s as the GCS spokesperson at clinical ... Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain… more
- Novo Nordisk Inc. (Seattle, WA)
- …brand strategies and the implications and importance of generating advocacy and support for them Demonstrates professionalism and a customer-focused approach with ... internal and external stakeholders by actively listening, identifying and...they currently position NNI products and devices Exercises prudent control over samples and other company property in accordance… more
- Novo Nordisk Inc. (Traverse City, MI)
- …access to build and maintain business-relevant relationships with customers: prescribers, support staff, pharmacies, and clinic administrators to gain access and ... NNI-approved solutions Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and… more
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start ... team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture,… more
- Tris Pharma (Monmouth Junction, NJ)
- …believe in each other and in respectful, open and honest communications to help support individual and team success.We have an opening in our Monmouth Junction, NJ ... continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross functionally with internal … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to business processes. Conduct user acceptance testing and provide training and support to end users. Participate with internal IT data teams/vendors to ... disorders. SummaryThis position is responsible for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global alignment on all technical Carvykti scopeProvide technical direction and support of an expanding global manufacturing network for best-in-class CAR-T ... product.Work collaboratively with internal and external partners to drive global process platform...performance worldwide for both Legend and partner sites.Provide technical support and leadership during Agency Inspections, filing of Submissions,… more
