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Principal Shelf Life & Stability Consultant

Grove -
Remote

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Job Details

Contract
$95 - $100 an hour

Qualifications

Stability testing
Polymers experience in materials engineering
Program design
Program management
Stability studies in drug product development
Sterilization
Biomaterials
Medical device manufacturing facility experience
Manufacturing
Cross-functional collaboration
Cross-functional team management
Leadership
Sensors
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full Job Description

Title: Principal Shelf Life & Stability Consultant (Gamma Sterilization / Single-Use Systems)
Start Date: ASAP
Duration Minimum 3-6 months. Chance of extension and possibility of FTE conversion based on business value 
Logistics: Mostly Remote. Occasional travel to sites and labs may be needed but will be expensed. Facilities are located in mid-Atlantic and new England. 
Hours/week: 40 hours
Bill rate: Open but target $180/hour. Can re-adjust if resource pay rate is higher
Manager Notes:

The hiring manager provided us the following pre-screen questions to help qualify candidates: 

Have you worked on shelf-life, stability, aging, or post-sterilization programs for single-use bioprocessing systems, sterile fluid path products, or polymer products?
Have you worked with items that are gamma irradiated, e-beam irradiated, X-ray sterilized, or otherwise sterilized?
Have you worked with product types such as tubing, connectors, filters, bottles, bioprocessing bags, caps, gaskets, clamps, valves, sensors, molded fittings, or manifolds?
Any references here to BPSA (Bio-Process Systems Alliance) or BioPhorum Group/BPOG would be positive indicator
What factors would you use to group components into matrixed product families? For example: material, supplier, function, fluid-contact status, gamma dose,  packaging, formulation...
How would you decide whether two components are similar enough to be covered by the same shelf-life rationale?
How would you build a near-term shelf-life extension strategy while long-term aging data is still being generated
How would you define acceptance criteria if the supplier does not provide detailed performance specifications?

JOB DESCRIPTION:

Our client is seeking a senior technical consultant to assess and develop an enterprise Shelf Life Management Program supporting custom Single Use Assemblies (SUAs) used throughout biopharmaceutical manufacturing.

These assemblies consist of supplier-manufactured tubing, filters, connectors, bags, and other fluid management components that are assembled, gamma sterilized, and supplied to customers for critical bioprocess applications.

Today, shelf-life decisions rely heavily on supplier-provided component shelf-life data. The client is looking to establish a more robust, science-based approach that distinguishes component storage life from post-gamma assembly performance while improving regulatory defensibility, inventory management, and long-term product lifecycle strategy.

This consultant will serve as a strategic advisor, evaluating current processes, reviewing existing evidence, identifying technical gaps, and developing a scalable roadmap for shelf-life management across the organization.

Responsibilities:

Assess the client's current Shelf-Life Management Program and supporting processes.
Review supplier shelf-life claims, technical documentation, and existing stability data.
Evaluate current scientific justification supporting shelf-life claims.
Assess the impact of gamma sterilization on materials and long-term product performance.
Identify gaps in available post-gamma evidence and recommend appropriate testing strategies.
Develop recommendations for stability studies, evidence generation, and validation approaches.
Evaluate complex components using material science principles along with form, fit, and function assessments.
Develop governance recommendations supporting supplier management, new component evaluation, change control, and lifecycle management.
Build a practical implementation roadmap for a scalable Shelf Life Management Program.
Provide strategic technical guidance to cross-functional teams including Engineering, Quality, Product Compliance, Supply Chain, and Regulatory.

Required Experience:

Shelf-life program development
Stability program management
Gamma sterilization
Plastics or polymer materials science
Material degradation
Medical device or biopharmaceutical manufacturing
Single-use bioprocess systems
Fluid management products
Packaging science
Sterility assurance
Engineering evaluation of product performance
Cross-functional technical leadership

Preferred Qualifications

Experience with one or more of the following is highly desirable:

Single Use Assemblies (SUAs)
Gamma sterilization validation
Stability studies (accelerated and real-time)
Shelf-life justification
Material compatibility testing
Form, Fit & Function evaluations
Extractables & Leachables (E&L)
ISO 11607 packaging validation
ASTM stability methodologies
FDA and ISO quality system requirements
Consulting experience leading strategic technical assessments
BPSA or BioPhorum (BPOG) participation or affiliation

Pay: $95.00 - $100.00 per hour

Work Location: Remote

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