Director of Clinical Manufacturing

Title: Director Clinical Manufacturing
Country: United States
State/Region: East Coast


Base Salary: $125,000 To $150,000

Pharmaceutical / Biotech

Manufacturing / Production

Will Relocate
Interview Travel ReimbursedThe ideal candidate has worked for these companies
Biogen Idec

Detailed Description

 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 Functions:

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.

Supervisory Responsibilities:

  • Manages department through subordinate supervisory personnel.

Required Skills:

  • 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



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