Packaging & Labeling Engineer III
Responsible for applying advanced and complex principles of packaging and labeling technology and engineering in the creation and maintenance of packaging and labeling designs for cryopreserved Cell and Gene Therapy products. Under minimal direction and supervision, establish and coordinate project priorities and tasks. Applies acquired packaging and labeling technology skills to manage projects to a successful conclusion with regard to cost, schedule, and performance, while applying the most appropriate technology and concepts to meet and/or exceed functional area and company objectives.
- Recommending and qualifying packaging and labeling materials and equipment, creating material specifications, performing packaging stability studies, working closely with Validation to execute shipping qualifications/validations, providing guidance to the manufacturing/packaging process, and leading these activities at the manufacturing site.
- Functioning under minimal supervision, the incumbent is accountable for Packaging and Labeling Development activities and projects, which impact manufacturing, marketing, and company profits.
- Responsible for the preparation of Packaging and Labeling documentation for Regulatory submission.
- Actively develops and applies project management skills compatible with the changing packaging technology environment. Maintains performance level and working relationships in stressful situations and under tight timelines. Independently develops, prepares, and implements packaging and labeling material specifications, packaging descriptions, labeling and bar code assignments that communicate product packaging requirements to company production support departments, providing the basis for the purchasing and planning of packaging and labeling materials to sustain plant manufacturing operations.
- Ensures that US and EU item serialization expectations will be met by the time of Cellectis’ first product registration/commercialization.
- Efficiently coordinates, communicates, and provides essential Packaging and Labeling Development project information, activities, and technical assistance to Development, Clinical, Planning, Manufacturing, Quality Assurance, and Purchasing in a timely manner without becoming the critical path.
- Initiates and performs packaging and labeling studies to contain package and label material cost or effect package and/or label changes that result in greater efficiency, less waste, longer stability, etc. Expresses desire to make high-quality decisions based on sound analysis and review of data and alternatives.
- Sees opportunities and works proactively and closely with the Engineering and Validation teams to assure all packaging and labeling materials and proposed future packaging/materials, meet legal, technical, and FDA requirements. Communication with Regulatory Affairs to provide necessary information, data, or specifications is an essential responsibility.
- Travel up to 10% of the time.
- Such other responsibilities and duties as the Company may from time to time assign.
- Bachelor's degree in life sciences, pharmaceutical sciences, packaging, or engineering, or a related discipline.
- 7+ years of work experience and 3-4 years experience managing projects in biotech or pharmaceutical industry.
- Proven ability to lead and motivate cross-functional teams to achieve results.
- Must have sound knowledge of cGMP processing.