- BrightSpring Health Services (Charlotte, NC)
- …+ IV Antibiotics + Enteral and Total Parenteral Nutrition + Anti-inflammatory Biologics + Inotropes + Clotting Factor and other specialty medications BENEFITS : ... + High-quality, affordable benefits for all Full-time and Part-time Employees* Medical, Dental & Vision Benefits plus, HSA & FSA Savings Accounts (PRN not eligible)* Supplemental Coverage - Accident, Critical Illness and Hospital Indemnity Insurance* 401(k)… more
- Actalent (Winston Salem, NC)
- …or related science. + 3-5 years of experience in the pharmaceutical, biologics , microbiology, sterile manufacture, or medical device industry. + Knowledge of cGMP ... and understanding of GxP, good clinical practices, and FDA guidelines. + Familiarity with bioassays and raw material test methods. + Knowledge of LIMS systems. + Experience in deviation handling, change control management, and OOS investigation. Additional… more
- Insight Global (Holly Springs, NC)
- …with Capital Projects, Engineering and Maintenance * Knowledge/experience in Biologics Drug Substance manufacturing operations * Experience managing or leading ... shutdown execution from operations ramp down through start up * Experience with Construction and Commissioning and Qualification projects (not leading these activities, just helping with coordination) * Understanding of supporting functions within a… more
- Takeda Pharmaceuticals (NC)
- …knowledge of buy-and-bill reimbursement models and payer dynamics + Skilled in complex biologics **TRAVEL REQUIREMENTS:** + Willingness to travel up to 50% of the ... time, inclusive of conferences on weekends, overnight programs as well as attendance at key internal meetings Individual must reside within territory boundaries given the extensive travel arrangements of this role. **More about us:** At Takeda, we are… more
- Boehringer Ingelheim (Charlotte, NC)
- …technical service, etc.) in broiler production is preferred. + Animal health biologics industry experience is a plus. + Field-based position, living in ... poultry-concentrated area, with preference to Southeastern United States. + Willingness to travel up to 50-65% of time (will include overnight travel). + Requires a thorough understanding of veterinary medicine, diseases, production and management, diagnostics… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ Master's degree preferred. + Typically requires 10 years in GxP or plasma/ biologics Quality roles. + 5+ years leading multi-site Quality Operations teams. + Strong ... inspection management experience (FDA, EMA, PPTA, CLIA/COLA, State, internal audits). + Experience with QMS systems (TrackWise, etc.). **Occupational Demands** : + Based at RTP headquarters, occasionally remote role with 40-60% travel to US plasma centers. +… more
- IQVIA (Durham, NC)
- …integrative product development strategies for pharmaceutical products, including drugs, biologics , and devices. This role will focus on clinical-commercial ... convergence and will encompass all phases of development from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability of success for candidate… more
- Sumitomo Pharma (Raleigh, NC)
- …Validation experience with multiple therapeutic modalities (eg API, solid dosage, biologics , gene therapies, drug/device combination products) is required. Must be ... familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes… more
- Merck (Durham, NC)
- …Degree. **Required Experience and Skills:** + Experience in vaccine or biologics manufacturing within a cGMP environment + Experience authoring technical ... documentation within a cGMP context + Proven leader with influence and outstanding communication (written & presentation) skills + Experience with project strategic plan development and management + Ability to foster a collaborative work environment focused on… more
- Merck (Durham, NC)
- …of the following areas, based on site activities; Medical Device/Combination products, Biologics , Vaccines, API's or Non Sterile or Sterile Drug Product + Specific ... technical knowledge in areas pertaining to the hiring site (eg, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation) + Knowledge of QBD development & submission requirements, as… more