Company: Emergent BioSolutions, Inc.
Posted on: March 28, 2020
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.
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: Responsibilities
Responsibilities and duties include, but are not limited to, the
- 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
- 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
- Prepare, review and approve Stability Annual Reports and other
- Recognize problems, provide insight and recommendation to
- 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
- 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
- Prepare or review submissions to FDA and other regulatory
agencies regarding method updates, corrections, or technology
- Interact with Contract, Corporate, and governmental agency
- 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
- Minimum of 5 years' experience within a cGMP / FDA /
- Previous experience with management and execution of Stability
- Experience with stability regression analysis and electronic
- Ability to conduct statistical analysis of stability data and
communicate the results to non-chemistry and non-statistical
- 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
- Ability to follow-up and follow-through on related
- Must have strong computer skills with MS Project, Minitab or
Jump, MS Word, Excel, and Adobe. IV: Physical/Mental Requirements
- Type/keyboard, visual acuity, stand, walk, sit, twist/turn,
reach outward, reach above shoulder, bend, squat/kneel, lift/carry
10lbs, pull 10lbs Use phone, fax, copier, computer, copier. Work in
areas where noise is above conversation level multiple locations,
restricted access laboratory and contact with select agents.
Organize/coordinate, analyze/interpret, problem-solve, make
decisions, supervise, plan, communicate, prepare written
communications, prepare transaction documents. 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. 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
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.
Keywords: Emergent BioSolutions, Inc., Washington DC , Manager, Stability, Executive , Gaithersburg, DC
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