Senior Manager, Packaging Engineering & Supply Chain Serialization Job at Sarepta Therapeutics
Sarepta Therapeutics Burlington, MA 01803
$132,000 - $165,000 a year
The Senior Manager, Packaging Engineering & Supply Chain Serialization reports to the Director, Global Supply Development & Product Security. This position will support design, development, and testing, technology transfer, qualification, validation, and production readiness of clinical, commercial, and international processes for the entire portfolio of RNA and Gene Therapy products. This position will work closely with Product Development, Labeling Development, Global Supply Chain, External Manufacturing, MS&T, QC, QA, RA, Computer Systems/IT Validation, and Commercial Operations to implement new processes and manage changes.
Primary Responsibilities Include:
- Lead research, design, and development of labeling and structural packaging including design verification testing for materials, technologies, and applications
- Lead tech transfer, process development and validation, and production readiness activities for commercial labeling, packaging, and serialization processes
- Assist serialization software design, development, installation, configuration, testing, validation, and deployment activities through the Software Development Life Cycle (SDLC) process
- Lead development of business and market specific regulatory requirements for product serialization
- Lead management and maintenance of serialization services and solutions including monitoring transactions in the production environment, troubleshooting, and resolving system issues, and supporting risk assessments for application and platform releases into validated state
- Support completion of internal product integrity risk assessments to help identify and quantify risks and research of the external factors that existing products or products in development may encounter which affect the likelihood of counterfeiting, diversion, tampering, and theft
- Participate in response, investigation, resolution, and reporting of product integrity incidents (both internally and externally reported events) including consult with other product integrity subject matter experts and resources based on defined roles and responsibilities
- Support development and maintenance of policies, procedures, work instructions, and guidelines related to labeling, packaging, serialization, distribution, and product integrity processes
- Support commercial artwork (technical) design and development
- Author technical plans, protocols, reports, risk assessments, and documentation for regulatory submissions as needed
- Contribute towards the manufacturing and supply strategy for Sarepta’s entire portfolio of products including RNA and Gene Therapy
- Help establish network of world class vendors, service providers, contract organizations, external consultants, and contractors, etc.
- Provide oversight and technical support of cGMP operations for clinical and commercial processes to ensure performance and control
- Be the person in-plant during validation, production readiness, and routine production as necessary
- Develop tools, processes, and criteria to help evaluate vendor performance
- Support technical, internal, and quality audits and regulatory agency inspections
- Participate in industry forums to identify best practices, trends, and technology advancements
Desired Education and Skills:
This role requires experience with labeling, packaging, serialization, and distribution operations, as well as experience working closely with packaging vendors, graphic service providers, contract packaging organizations, contract test laboratories, third party logistics providers, serialization service providers, and product integrity service providers.
- 8 years of direct experience in the biopharmaceutical, chemical, or related industry, preferably with at least 4 years in a position related to engineering, operations, or supply chain.
- Experience with temperature sensitive products, equipment, processes, systems, and materials
- Knowledgeable with FDA, CFR, ISTA, ASTM, ISO, ISTE, ICH, USP, PDA, WHO, GxP, etc. standards, guidelines, and regulations
- Process improvement, Operational Excellence, Lean Six Sigma experience
- Experience with CAD, Adobe Illustrator, and InDesign
- Strong quantitative and qualitative analytical abilities
- Strong technical writing, communication, and people skills
- B.S. required in Engineering or related scientific discipline
- Domestic and international travel required
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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