Sr. Manager Downstream

Location
Baltimore (Bayview), MD, US
Posted
Jun 03, 2021
Ref
750732500
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary

The Sr Manager, Downstream Manufacturing Operations position reports to the Sr Director of Manufacturing & Supply Chain at EMOB. The position is responsible for downstream 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.

II: 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 Emergent 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
  • Review 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 troubleshoot 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 Emergent Quality Assurance 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

 

 

 

  • Bachelor's Degree in biology, chemistry, or related scientific or engineering field
  • Minimum of 8 years of GMP pharmaceutical experience; minimum 5 years of supervisory experience; hands-on experience with installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment
  • Computer literate (Word, Excel, and PowerPoint)

 


There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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