Manager, Stability

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 objectives of the stability program are (1) to determine an appropriate and safe stability profile of a product/drug/device and (2) to justify its shelf-life.

The Stability Manager, Device Quality will be responsible for day to day management of the stability program for the Device Business Unit (DBU). This includes the writing of technical assessments, protocols, reports, annual stability reports, quality system documents directly related to stability, as well as supporting activities within the stability program. The individual in this position will be directly responsible for gathering, preparing and reviewing all data from the stability program required to support Management Review, Annual Reports, filing update and submission. This position is located in Gaithersburg, MD.

The Stability Manager, Device Quality will act as a liaison with external and international Contract Manufacturing Organization (CMO) and Contract Research Organization (CRO) partners to monitor, support and coordinate DBU stability program.

II: Essential Functions

Responsibilities and duties include, but are not limited to, the following:

• Develop, oversee and manage DBU strategic and tactical approach to a robust stability program for DBU product (drug, device, medicinal, and combination production as appropriate) and ensure alignment with ICH guidelines and regulations applicable to the distribution of each product.
• Manage the stability inventory level including the reserve sample program and subsequent samples storage and retention periods.
• Manage the specification program by establish technical sound specification and expiration
• Serve as the point of contact for outside testing for stability at CMOs or other laboratories.
• Oversee the qualification, temperature mapping, and maintenance of the stability chambers to ensure compliance and standards are met.
• Prepare, review and approve Stability Annual Reports and other technical reports.
• Recognize problems, provide insight and recommendation to leadership management
• Conduct and support OOS investigations on Stability related testing and product release as required.
• Provide support for regulatory health authority/CDC submissions as necessary, based on stability program data.
• Author and collaborate on SOPs, Deviations, CAPAs, and Change Controls related to the stability program.
• Track and trend stability data to detect potential concerns and report to Management.
• Provides evaluation and assessment of compliance of testing methods per relevant ICH, USP, EU, Health Canada, MRHA and FDA guidance documents
• Provide support as SME around assay development, transfer, and assay validation activities for DBU.
• Provide support as subject matter experts during investigations of testing problems, technical updates at CMOs and compliance deviations.
• Prepare or review submissions to FDA and other regulatory agencies regarding method updates, corrections, or technology changes.
• Interact with Contract, Corporate, and governmental agency auditors.
• Explore and introduce new technologies for advancements and improvement to update current test methods and workflow.

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

• B.S. in Chemistry, Biology, Biochemistry, or other related field
• Minimum of 5 years' experience within a cGMP / FDA / Pharmaceutical/Device environment.
• Previous experience with management and execution of Stability Programs preferred.
• Experience with stability regression analysis and electronic tools, preferred
• Ability to conduct statistical analysis of stability data and communicate the results to non-chemistry and non-statistical personal.
• Strong written and verbal communications skills.
• Self-starter and has the ability to work independently and prioritize effectively with little or no direction
• Must be able to influence without authority in a cross-functional environment
• Ability to follow-up and follow-through on related activities
• Must have strong computer skills with MS Project, Minitab or Jump, MS Word, Excel, and Adobe.

IV: Physical/Mental Demands

• The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
• The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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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.