- WuXi AppTec (Natick, MA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position will ... lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... Provide CMC regulatory strategy input and expertise in the...marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + **Regulatory Knowledge:** Demonstrates expert knowledge of US/EU… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Gilead Sciences La Verne Engineering is seeking a highly motivated and knowledgeable ** Senior Manager , Project Management New Product Line Manufacturing - ... Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory/ CMC , EHS, Finance, IT, and Engineering. ** Project ...or MBA. + 3+ years successfully serving as a project manager . + Proven experience in managing… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be...CMC team and other key functions such as project management, QA and Regulatory, the ideal candidate must… more
- Sumitomo Pharma (Bismarck, ND)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Supply Chain** . The Senior ... supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …questions and drive business strategy using advanced data science and analytics. The Senior Manager , Development to Launch Analytics will join a dynamic and ... that drive our enterprise forward. Reporting directly to the Associate Director or Senior Director, Development to Launch Analytics, you will play a pivotal role in… more
- Lilly (Indianapolis, IN)
- …POs and invoices from vendors by effective communication between vendor, finance and CMC PM teams. + Manage the collection of performance metrics of vendors by ... overall capability and capacity of the team. + Attend project team meetings with collaboration partners as needed. +...early or late phase and basic technical understanding of CMC functions and roles. + Demonstrated ability to think… more
- Vera Therapeutics (Brisbane, CA)
- …in the US and globally to support development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * ... Title: Senior Manager , Clinical Regulatory Location: Brisbane,...regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams * Evaluate proposed clinical protocol changes for… more
- Sumitomo Pharma (Phoenix, AZ)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- POWER Engineers (Indianapolis, IN)
- **PTE Senior Field P&C Engineer** Location **Indianapolis** Secondary Locations **Indianapolis** Job Code **18277** \# of openings **1** Apply Now ... please send us your resume. This position reports to the Midwest Region Department Manager or Area Lead. Under the guidance of an experienced Field Engineer or… more
- ThermoFisher Scientific (Greenville, NC)
- …management and oversight of Non-Interventional Clinical Trials in a CRO/Pharma setting.** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Non-Interventional Oversight Team… more
- Stantec (Reno, NV)
- …and industry experience to consistently produce project deliverables that meet project requirements and the project manager and client's expectations. ... plumbing. **Your Key Responsibilities** + With direction from a project manager and/or Professional Engineer Design, develop,...as part of a coordinated design team. + Assist senior engineers in the design and development of mechanical… more
- Bausch Health (Bridgewater, NJ)
- …development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in ... your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for… more
- GE Aerospace (West Chester, OH)
- **Job Description Summary** The Senior Design Engineer position is a mid to late career 'hardware owning' engineer reporting to an Engineering Manager within the ... of assigned Commercial, Aero-derivative High pressure Turbine Airfoils and CMC Shrouds. In this role, you will be on...meet technical requirements and business goals under mentorship of senior engineers. + Lead technical projects with moderate to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Senior Quality Control Analyst Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... at the Monroe manufacturing facility, reporting to the QC Manager . Primary responsibilities for this position will be: perform...the Revenue and Capex Budget as per spent analysis project . + Execute and maintain quality system controls to… more
- Mallinckrodt Pharmaceuticals (Hazelwood, MO)
- Job Title Manager , Analytical Chemistry Requisition JR000014958 Manager , Analytical Chemistry (Open) Location Hazelwood, MO Additional Locations St. Louis, MO ... Job Description Summary Job Description The Manager , Analytical Chemistry, offers the opportunity to play a key part in advancing new drug development and supporting… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's ... Pharmaceutical Development and Manufacturing Teams to develop strategies, meet project deliverables, solve business problems. The position includes all elements… more