Analytical Chemistry Stability Coordinator

Location
San Diego, CA
Posted
Apr 20, 2022
Ref
875001600
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.

The Stability Coordinator is responsible for administering and ensuring GMP compliance with the San Diego Research and Development Stability program. This position administers the stability program to establish and support shelf-life for development programs and products at the San Diego R&D site, including Phase I/II activities. Additional responsibilities include purchase, qualification, and preventative maintenance of lab equipment, as well as training new lab personnel on basic lab equipment.

 

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

  • Assist in managing the site stability program ensuring each stability study is in alignment with CFR and ICH guidelines, by reviewing industry guidance
  • Create and execute stability protocols which includes: 
    • Write program specific stability protocols, including cell bank and drug substance R&D products
    • Write final and interim stability reports
    • Pull and submit samples to the AC and contract/external laboratories
    • Oversight of stability testing to ensure timely completion, to meet all predefined timepoints 
    • Manage contract testing purchase orders for stability and release testing
    • Independently perform routine inventory of all stability samples
    • Routine inspection of stability samples or product retains
  • Enter stability data and maintain stability data sets
  • Perform stability data trend analysis where applicable, present stability data and trends to relevant stakeholders
  • Perform stability testing on a continuous basis and release testing as needed
  • Maintain the stability pull calendar to ensure all pull are made on time
  • Communicate testing timeframe requirements and scheduling to the appropriate laboratories
  • Clean and maintain stability chambers (including mopping/wiping with cleaning agents, ensuring proper function, tag out non-functioning equipment, etc.)
  • Manage the approval and purchase of new equipment for the AC Department.
  • Manage the department equipment inventory and operational status.
  • Preventative Maintenance of equipment. Track and organize service contracts for all laboratory equipment, schedule vendors, work with Validation and Quality Departments to release equipment for GMP use.
  • Assist in AC support functions to ensure operational excellence
  • Assist with various AC projects as necessary
  • Create new SOPs and revise existing SOPs; write deviations, CAPAs, and Change Controls as needed
  • Participate in writing and revising product specifications or sampling plans

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.

 

Minimum Education, Experience & Skills

  • Bachelor’s in Chemistry, Biochemistry, Microbiology, or other related scientific field with a minimum of 6-7 years of relevant experience within a cGMP Biotechnology/Pharmaceutical environment or Master’s Degree with a minimum of 5 years of relevant experience
  • Must possess skills and knowledge of implementing and maintaining a complaint stability program
  • Previous experience with supervising or leading stability programs is required
  • Strong written/oral communication and presentation skills required
  • Must be highly organized, detail oriented, and able to manage multiple projects at once
  • Ideal candidate will have laboratory skills that include compendial testing such as Appearance, Fill Volume, Particle Size, pH, Osmolality, Container Closure Integrity Testing, and experience with simple analytical instrumentation
  • Strong knowledge of Good Manufacturing Practices and Good Laboratory Practices
  • Experience with HPLC, GC, UV, or IR Spectroscopy and Sub-Visible Particle Analysis is a plus
  • Critical thinking skills, with an ability to evaluate systems and processes as part of continuous improvement
  • Strong initiative, organization, and ability to work independently
  • Must have strong computer skills with MS Word, MS Project, Excel, PowerPoint, and Adobe
  • Experience with generating Crystal Reports is strongly desired, but not required
  • Knowledge of JMP (or other statistical software) and LIMS systems
     

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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.