Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Director, CAR-T Packaging Operations
Serve as the primary point of contact for Celgene on applying advanced principles of packaging design/engineering and operational design in preparation for commercial launch for multiple CAR-T assets.
Under minimal direction and supervision, establish and coordinate project priorities and tasks. Applies acquired packaging technology skills to manage projects to a successful conclusion while optimizing cost, schedule and performance, and while applying the most appropriate technology and packaging concepts to meet or exceed company objectives.
- Recommending and qualifying packaging materials, creating material specifications, performing packaging stability, shipping qualifications/validations, providing guidance to the manufacturing/packaging process, and lead product clinical and commercial labeling activities at the manufacturing site
- Support design and build of shipper physical and information flows to ensure Chain of Identity and Chain of Custody of patient cells
- Completing a detailed packaging development design gap assessment in preparation for BLA filing and PAI inspection readiness. Leading the closure of resulting action plans coming out of the gap assessment.
- Ensuring compliance with all of Celgene packaging development requirements per global SOP which are relevant to the BB2121 and/or JCAR
- Functioning under minimal supervision, accountable for Packaging Development activities and projects which impact manufacturing, marketing, and company profits.
- Preparation of Packaging documentation for Regulatory submission.
- Actively develops and applies project management skills compatible with the changing packaging technology environment. Maintains performance level in stressful situations and under tight time lines. Independently develops, prepares, and implements packaging material specifications, BOMs, packaging descriptions, labeling and bar code assignments which communicate product packaging requirements to company production support departments, providing the basis for the purchasing and planning of packaging materials to sustain plant manufacturing operations.
- Efficiently coordinates, communicates, and provides essential Packaging Development project information, activities, and technical assistance to Development, Clinical, Planning, Manufacturing, Quality Assurance, and Global Supply in a timely manner without becoming the critical path.
- Initiates and performs packaging studies to contain package material cost or effect package 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 Development team and others to ensure all packaging 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.
Leadership, Values and Behaviours
- Exhibits ability to work hard and smart, and make decisions with timely responses to assignments.
- Prepares in advance and establishes a course of action for assigned projects that is efficient and achieves results. Recognizes priorities, sets daily goals and uses effective means for self and project management.
- Accepts responsibility for managing own performance.
- Demonstrates ability to adapt and handle change, deal with diverse responsibilities and multi-task between one project and another without difficulty. Shows ability to handle job pressure and stress and to cope with frustration or conflict without overreacting when faced with time commitment pressures.
- Key customers include Pharm Dev, Engineering, Manufacturing, Regulatory, Clinical, Supply Chain, Quality Assurance, and others. Takes ownership of quality issues and implements improvements.
- Brings new ideas for continuous improvement and drives implementation. Communicates effectively and efficiently among peer groups and support staff.
- Promotes open communication among peers
- Attention to detail and forward thinking ability
- Perform a variety of duties to support team objectives.
Bachelor’s Degree in Engineering (Packaging/Mechanical preferred). Certified Packaging Engineer desired.
- 5-10 years engineering experience, including experience with FDA regulations, medical, drug and device products.
- Supply chain or other operational experience desirable
- Cold Chain experience required
- Experience in packaging Blood or Cells preferred
- Experience in cryogenic preferred
Competencies (Describe the knowledge, skills and behaviours needed)
- Understanding and familiarity in pharmaceutical or medical diagnostic industry.
- Experience with LN2 Packaging/Dry Shippers/ Dewars, Blood Packaging
- Technical packaging technology knowledge relating to materials, equipment, design, and material specification writing.
- Excellent technical written and verbal communication skills. Experience negotiating Contracts, SLA’s and QAA.
- Computer expertise in application programs such as word processing, spreadsheets, relational databases, project management, and power point.
- Good judgment and decision skills.
- Problem solving and multi-tasking.
- Project supervision and project management skills.
- Ability to work independently.
- Proficient with Oracle
- Ability to adapt and handle change
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.