|Title: Director Clinical Manufacturing
Country: United States
State/Region: East Coast
||$125,000 To $150,000
Pharmaceutical / Biotech
Manufacturing / Production
Interview Travel ReimbursedThe ideal candidate has worked for these companies
| Director Clinical ManufacturingOur client is a fully integrated biopharmaceutical company that discovers, develops, manufacturers, and commercializes medicines for the treatment of serious medical conditions
Summary:Our client is currently seeking a talented and motivated Director Clinical Manufacturing to join our Clinical Manufacturing department reporting to the Sr. Director of Clinical Manufacturing. This is a new position due to growth. The ideal directs all facets of clinical production of recombinant proteins within assigned area(s).
Essential Duties and Responsibilities include, but are not limited to, the following:
- Implements and improves processes developed by Process Development or Process Sciences for manufacturing proteins at various scales.
- Implements formulations developed by Formulation Development for manufacturing proteins at various scales.
- Participates in and sometimes oversees Validation activities involving Manufacturing equipment and processes.
- Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
- Ensures the effective use of material, equipment and personnel in producing quality products.
- Formulates and recommends manufacturing policies, schedules, procedures and programs.
- Performs personnel management functions including scheduling of vacations, personnel development, and performance evaluations.
- Recommends capital expenditures and aids in the realization of capital projects;
- Ensures that safety standards are maintained.
- Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
- Prepares and administers expense and capital budgets.
- Represents manufacturing during regulatory and client audits.
- Provides technical input to resolve process problems.
- Writes, reviews, and/or approves Standard Operating Procedures, specifications or other controlled documents as needed.
- Develops department goals, objectives and metrics.
- Works closely with staff to develop and manage individual goals and objectives.
- Leads and implements continuous improvement initiatives.
- Others as required.
- Manages department through subordinate supervisory personnel.
- Strong knowledge of recombinant protein manufacturing techniques and methods, all liquid solution preparations, and purification and formulation of recombinant proteins;
- Intermediate knowledge of word processing, spreadsheet, database management, statistical analysis, graphing, scheduling, and presentation software;
- Excellent interpersonal, written, and oral communication skills;
- Substantial knowledge of cGMPs and cGLPs.
- Bachelor, Master, or Doctorate degree in any of the physical or biological sciences, or chemical engineering; 9-12 years biopharmaceutical/biotech work in a GMP production facility with BA/BS, alternatively 8 to 10 years with MA/MS, or 4-7 with PhD and progressive experience in managing/directing operations and employees in a biotech manufacturing environment. Knowledge of cGMP, ISO, QSR, and ICH guidelines.
Melanie Mays Kirk
Empyrean Consulting, Inc.
Texas Number 214-457-3500
California Number 650-515-3604