- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Merck & Co. (Rahway, NJ)
- …Decision Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation , Manufacturing Quality Control, Manufacturing Scale-Up, ... post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various… more
- Eisai, Inc (Exton, PA)
- … Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation , and… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in… more
- Merck & Co. (Rahway, NJ)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (Durham, NC)
- …and patients on time, every time, across the globe. The main function of the Associate Specialist, Quality Control is to assist in the assurance of the ... and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This ... to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing… more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene ... execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Ability to perform routine… more
- Health eCareers (Philadelphia, PA)
- …experience and training in Histocompatibility and Immunogenetics at the Assistant or Associate Professor level in the Clinician Scholar track (tenure eligible) or ... record. Individual in this position also serves as the Assistant/ Associate Director of Histocompatibility and Immunogenetics Laboratory.The laboratory serves the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. Relationships Reports to: According to the ... manufacturing Perform area equipment and process validations in accordance with validation procedures Perform in-process product testing in accordance with standard… more
- Krystal Biotech (Pittsburgh, PA)
- …Job Description Summary: Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) ... to support process validation planning, design, and execution. This person will be...a continuous improvement mindset to processes and departments. Produce high- quality documentation that meets applicable standards and is appropriate… more
- Sotera Health Services, LLC (Grand Prairie, TX)
- …of IQ/OQ/PQ activities of new or existing facility equipment. Maintains the quality and integrity of information required for validation records. Liaison ... duties as required to support the overall regional facility operation and quality system. Supervision Given May supervise/guide the validation departments within… more
- KOHLER (Kohler, WI)
- …manufacturing locations.Integrate new products and processes that meet or exceed safety, quality , cost, timing, and delivery metrics for both Product Development and ... with cross-functional teams in Marketing, Purchasing, Engineering, Program Management, Quality , and Industrial Design.Proactively propose and implement solutions that… more
- KOHLER (Palo Alto, CA)
- …Oversee multiple projects, ensuring they are delivered on time and meet quality standards.Collaboration and Communication: Serve as the key point of contact between ... team and other departments, translating technical concepts into business solutions.Data Quality Oversight: Ensure the team maintains high standards for data … more
- BioSpace (Neshanic Station, NJ)
- …make life better for people around the world. Eli Lilly and Company seeks a Quality Assurance Associate Director (M2) to provide quality direction for ... and oversee data integrity for paper based and electronic systems, including quality review of audit trail reviews. Oversee the implementation of risk-based… more
- Amgen, Inc. (West Greenwich, RI)
- …team. Join us and transform the lives of patients while transforming your career. Associate Manufacturing - Nights What you will do Let's do this. Let's change the ... associates that leverage adaptability, agility, teamwork, and curiosity. The Manufacturing Associate I at Amgen supports the production process by operating… more
- Instant Systems Inc (Norfolk, VA)
- …spend it making a difference on a worthy mission. Description Job Summary: Associate Engineer (AE). The AE will apply engineering principles to acquire, implement, ... designs and initial engineering builds design reviews, verification testing, product validation , and usability testing tech transfer to production Ensuring product… more
