Upstream Manufacturing Manager

4 weeks ago

Baltimore, United States latitude Full time
  1. JOB SUMMARY
The Senior Manager Manufacturing position reports to the Sr. Director of Manufacturing & Supply Chain at our client's Manufacturing Operations Baltimore (EMOB). The position is responsible for manufacturing operations. This includes management of manufacturing staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments and being on-call during critical process operations.
  1. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Provides hands-on supervision of manufacturing staff in the operation of pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
  • Establishes performance standards and goals for Manufacturing Supervisors and Associates
  • Demonstrates and enforces understanding and adherence to our client's policies, GMP standards and safety procedures
  • Hires, evaluates, trains, develops and terminates staff
  • Oversee development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models.
  • Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.
  • Updates the Sr. Director of Manufacturing & Supply Chain on process status and achievement of objectives
  • Resolves problems of manufacturing staff and manages manufacturing resources
  • Develops and maintains manufacturing budgets
  • Frequently Interacts with other site group leaders including Sr. Director and VP level staff
  • Prepares and conducts technical presentations of manufacturing processes
  • Performs annual performance appraisals of staff reporting to the position
  • Generate Batch Records, SOPs and Protocols as required
  • Reviews Batch Records, SOPs and Protocols as required
  • Verifies manufacturing readiness including raw materials, staff training, suite cleaning and equipment operation
  • Responds to or delegate duty as primary, manufacturing alarm response representative according to site alarm response policy
  • Works with subject matter experts to trouble-shoot and/or optimize processes as required
  • Supports the technical transfer of new products into the manufacturing area
  • Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
  • Supports QA during audits and regulatory inspections
  • Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • BS degree in biology, chemistry or related scientific or engineering field
  • Minimum 8 years of GMP pharmaceutical experience; Minimum 5 years supervisory experience; Hands-on experience with the installation, operation, cleaning and maintenance of pharmaceutical GMP equipment
  • Computer literate (Word, Excel and PowerPoint)

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