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Technical Operations Manager

Education:
BS Degree in Engineering or Life Sciences
Location:
Atlanta, GA 30318 US (Primary)
Career Level:
Experienced Manager
Category:
Technical Operations
Job Type:
Full-time
Job Description:

The Technical Operations Manager: Provides support to all company departments on technical issues related to Operations. Completes any major investigations into events within the production and packaging departments.  Supports the technology transfer of processes from R&D into production or packaging.

Essential Job Functions

  • Lead technical team to support the accountabilities.
  • Determine the operational requirements associated with new product Requests for Proposal.
  • Determine cost and lead times for any new equipment investments that are required for new product production.
  • Initiate, and/or review change controls (as the technical subject matter expert) associated with Manufacturing and Packaging Master Documents.
  • Conduct and author major deviation investigations that establish root cause and appropriate corrective actions when process expectations have not been met.
  • Review and approve IQ/OQ/PQ documents for operations equipment.
  • Train Manufacturing and Packaging personnel on equipment of new design and operational principal.
  • Review/write/revise SOP’s that govern the Operations department (including Manufacturing, Compression, Packaging, etc.).
  • Identify areas for COGS improvement to the process, operation or scale and present the cost benefit case for making those changes.

 

Job Requirements:

Requirements for the Position

  • Relevant degree in Engineering or Life Sciences with proven experience providing technical support to a pharmaceutical manufacturing environment.
  • A proven track record of accomplishment in developing drug product manufacturing processes and involvement in cGMP manufacturing operations, with experience in the technical transfer, scale-up and process validation of new drug products.
  • A working knowledge and practical experience with the design, procurement and qualification of a wide range of pharmaceutical manufacturing equipment.
  • A track record of problem solving escalated technical issues.
  • Expertise in support of production process optimization, scale-up, and process transfer to clinical and commercial manufacturing.
  • Demonstrated knowledge of manufacturing process validation procedures, protocols and requirements for preclinical and clinical manufacturing.
  • Has considerable knowledge in the field of solid dosage formulation and analysis.
  • Knowledge of formulation and process development of various oral dosage forms.
  • Working knowledge of GMP regulations in cGMP manufacturing environment.
  • Rigorous attention to detail in transfer protocols. Ability to comprehensively document in writing the learning from each transfer.
  • Proficiency in MS Excel, MS PowerPoint and MS Word is essential
  • Previous supervisory experience required.

Physical Demands

  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Walking, sitting for long periods, and repetitive hand motions.
  • This role will be based in Atlanta and some travel will be required.

Direct Reports and Organizational Relationships

  • Position reports to VP, Operations.
  • The Technical Operations staff will report to the Technical Operations Manager.
Apply and Submit Resume/CV.