Specialist I, QC

Location
Baltimore (Bayview), MD, US
Posted
Sep 05, 2020
Ref
673425100
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

I. JOB SUMMARY

This Specialist position is primarily responsible for highly technical level work supporting the Stability program, including direct support for Biological License Application (BLA) submission relating to the stability program data.

The Specialist is responsible for the writing of technical assessments, protocols, reports, quality systems documents as well as supporting activities within the stability program. The individual in this position will be directly responsibility for gathering, preparing, and reviewing all data from the stability program required to support submissions, including but not limited to the BLA.

The Specialist will act as a technical liaison with external and international Contract Manufacturing Organization (CMO) and CRO partners. The role also includes responsibilities for the Regulatory Surveillance and Tracking and Trending programs.

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

• Assist in managing the Emergent Baltimore (EMOB) product stability program ensuring each stability study is in alignment with CFR and ICH guidelines, by reviewing industry guidance
• Create and execute stability protocols (clinical and commercial products) which includes:
o Write Master and lot specific Stability Protocols
o Write final and Interim Stability Reports
o Pull and submit samples to the QC laboratories
o Ship samples for testing at Contract Laboratories
o Oversight of stability testing to ensure timely completion
o Manage contract testing purchase orders for Stability and Release testing
o Independently perform routine inventory of all stability samples
o Routine inspection of stability samples or product retains

• Serve as SME and representative on the cross functional BLA submission team
• Work closely with the FAL (Functional Area Lead) in preparing documentation in support of BLA requirements.
• Collaborate with Quality Assurance, Project Management and Regulatory representatives
• Evaluate complex analytical data from the Stability Program
• Provide support for FDA/CDC submissions as necessary, based on stability program data.
• Enter stability data into LIMS or EXCEL and maintain stability data sets
• Perform stability data trend analysis on a continuous basis
• Assist in QC support functions to ensure operational excellence
• Compile data and write Annual Stability reports and other technical reports as necessary
• Maintain the Stability Pull calendar to ensure all pull are made on time
• Communicate testing timeframe requirements and scheduling to the appropriate laboratories
• Participate in writing and revising product specifications

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
• 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, HPLC, UV, IR Spectroscopy, and experience with simple analytical instrumentation is a plus.
• Strong knowledge of Good Manufacturing Practices and Good Laboratory Practices
• Capable to interpret statistical data
• Must have SOP, investigation, and project protocol writing skills
• Strong initiative, organization, and ability to work independently
• Must have strong computer skills with MS Word, MS Project, Excel, PowerPoint, and Adobe
• Previous experience with Laboratory Information Management Systems. Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.