Manager, Clinical Production PDP

Location
San Diego, CA, US
Posted
May 02, 2021
Ref
729656200
Hotbed
Biotech Beach
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.

Position Summary

The Clinical Production Manager is responsible for clinical GMP production of vaccine material. This includes GMP bioprocessing that involves cell banking, cell culture in Bioreactors, CellSTACKs, transfection and infection, harvest, purification and ultrafiltration/diafiltration. The candidate will plan the production timeline and assist in budget. The Manager will oversee the production team and ensure all quality requirements are being met. The candidate will also support technical transfer to commercial production facilities.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Lead vaccine production: cell culture, infection/transfection, harvest, purification
  • Lead cross functional department meetings
  • Coordinate with QA, AD/QC, VCM teams to ensure production timelines are met
  • Coordinate with VCM and vendors to ensure cGMP facility maintains compliance for clinical production
  • Collaborate with Technical Lead(s) to ensure successful use of equipment and execution of processes
  • Support the transfer of technology to commercial production facilities
  • Review manufacturing SOPs and Batch Records
  • Perform Production Review of executed Batch Records
  • Initiate/Review investigations, deviations, risk assessments and CAPAs
  • Lead/support process development projects


Minimum Education, Experience and Skills
  • Bachelors of Science/Engineering in Biology, Chemistry, Chemical Engineering, or related discipline
  • Minimum 8 years of relevant industry experience
  • Demonstrates an ability to think and act independently; accepts supervision, works quickly and accurately in a fast-paced environment, critically analyzes data and proactively solves problems
  • Excellent written and verbal communication skills
  • Cell culture and purification skills required
  • cGMP experience required
  • Proven Leader and Team Player


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.

.buttontextd24067979861e38d a{ border: 1px solid transparent; } .buttontextd24067979861e38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }