- Bristol Myers Squibb (Indianapolis, IN)
- …radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops and drives Quality ... the following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. Senior Director , CMC Statistics **What you will do** Let's do this. Let's change ... and commercial products across different therapeutic areas. The Senior Director , CMC Statistics, will manage, act as...manage, act as a technical expert for, and provide quality oversight of the Global CMC Statistics… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... Communicates regulatory decisions and strategy to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …innovative CMC regulatory strategies and the preparation and submission of high‑ quality CMC sections of INDs, CTAs, and original marketing applications ... Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics...+ Directs and oversees the preparation and review of high- quality CMC related regulatory submissions and leads… more
- Lilly (Boston, MA)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions. +… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -... Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... Teams (ASTs) and key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching asset strategy to effectively… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
- BeOne Medicines (Emeryville, CA)
- …CMC strategies as well as lead the team authoring and managing CTD CMC sections to ensure on-time and high- quality submissions for investigational, marketing, ... of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development, manufacturing, Quality , etc. including minimum 8 years… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- Takeda Pharmaceuticals (Lexington, MA)
- …This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical ... follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA … more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- Merck (Madison, WI)
- **Job Description** ** Director , Combination Product Regulatory CMC - (R5)** This Principal Scientist position is equivalent to a Director position. Under ... direction from the Combination Product Regulatory CMC Team Leader, the Principal Scientist is responsible for...510(K)s, CE markings. + Collaborate with Device Development, Device Quality , and other Drug stakeholders to communicate and align… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Site CMC ensures efficient and compliant management of regulatory ... scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory … more
- UTMB Health (Gatesville, TX)
- Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY_** **:** Serves as medical director for a number of correctional facilities within a designated region.… more
- UTMB Health (Friendswood, TX)
- Program Mgr UR/Case Management - CMC - Clear Lake Center **Friendswood, Texas, United States** Nursing & Care Management UTMB Health Requisition # 2405887 The ... issues that cross multiple departments and/or services to ensure optimal quality , cost, and service/outcomes. Supports and actualizes the UTMB Utilization… more
- UTMB Health (Dickinson, TX)
- Mental Health Clinician - CMC - Carole Young **Dickinson, Texas, United States** Social Service UTMB Health Requisition # 2404113 The mission of Correctional Managed ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- Atlantic Health System (Pompton Plains, NJ)
- Under the direction of the Laboratory Director , the Manager, Laboratory Operations will coordinate and oversee a wide variety of administrative, personnel and ... Lab, Blood Bank, Phlebotomy and Point of Care + Strong emphasis on quality management and strategic thinking in Laboratory Management is important. This role acts… more
- Atlantic Health System (Pompton Plains, NJ)
- …and processes to increase efficiency and reduce costs while maintaining service/mission quality . + Provides data on patient care issues, maintains reports, analyses ... enters one of our facilities, will receive the highest quality care delivered at the right time, at the...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- Atlantic Health System (NJ)
- …versus items received in department. + Rotates and inspects linen for compromises in quality . + Ensures that labels are accurate, legible, and exist on all carts and ... enters one of our facilities, will receive the highest quality care delivered at the right time, at the...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more