Bristol Myers Squibb Company

Sr. Manager Clinical Labeling - Cell Therapy

Location
Summit West, NJ, United States
Posted
Sep 03, 2020
Ref
R1529284
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Come, join the BMS Cell Therapy Development and Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Global Manufacturing Science and Technology (GMS&T) Division of CDTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external and internal manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

POSITION SUMMARY:

The Cell Therapy Division and Operations Clinical Label Manager is responsible for establishing the global process for managing investigational medicinal product labeling at BMS.

The successful candidate will support design, development, and implementation of clinical Labeling and Packaging (L&P) for cell therapy programs within BMS. Responsibilities may also include; technical integration of new products/changes at manufacturing sites, artwork management (label proof approval), Material Qualifications, Vendor Management, Change Management (change controls), and Specifications Management of critical L&P materials.

The incumbent is expected to work independently with cross functional teams (Regulatory, Manufacturing Operations, Quality/ QP's, Medical Affairs, Patient Operations, IT, Supply Chain, Validation, and Global Manufacturing, Sciences, and Technologies) to manage various functions of artwork and packaging including; artwork/label proofs, materials of construction, component die-lines, specifications, and technical challenges that occur at the manufacturing site.

Duties/Responsibilities:
  • Establish BMS Clinical Labeling process for cell therapy programs.
  • Manage site and global responsibilities regarding artwork, labeling and packaging.
  • Oversee technical challenges for material, label & packaging selection. Identify 'best practices' for label printing. Coordinate technical investigations when challenges arise at the printing site.
  • Coordinate the end to end label development process and integrate product life cycle management changes. Lead project teams through change management process of proposed changes.
  • Coordinate with label, packaging and distribution vendors to ensure key project milestones are met.
  • Identify gaps in the process, and update policies/procedures as necessary.
  • Provide training to new users across all functional groups using the system
  • Proactively mitigate & communicate issues between; Regulatory, Manufacturing Operations, Quality/ QP's, Medical Affairs, Patient Operations, IT, Supply Chain, Validation, and Global Manufacturing, Sciences, and Technologies.
  • Ensure compliance with SOPs and WPs and external procedures. Update SOP's & WPs as needed.
  • Monitor lead times for creation of approved labels and performance metrics.
  • Oversee IND/IMPD Submissions for Clinical Trial Labeling
  • Establish Cellular Therapeutics Translations Library
  • Integrate CTDO Labeling and Artwork Management philosophy with lean objectives and strategic assets.
  • Support multiple Clinical Drug Product manufacturing facilities inclusive of both internal and external.


QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc.:
  • Demonstrated skills in project management with the ability to independently plan, prioritize, schedule and coordinate multiple projects simultaneously
  • Experience in a cGMP environment with track record of managing multiple quality records.
  • Knowledge of packaging, labeling and printing technologies
  • Experience with Label and artwork design, Thermal Transfer Printers, Labeling Software/Systems, Label Testing, COI/COC preferred
  • Strong verbal/written communication skills and ability to influence at all levels is required
  • Ability to think strategically and to translate strategy into actions
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment
  • Is expected to be flexible in adapting to changing project priorities and work assignments.
  • Ability to work under pressure and demanding deadlines.
  • Experience with new product development including Global Commercial Launches.
  • Must have excellent attention to details with focus on quality.
  • Basic analytical and problem-solving skills, with ability to analyze information / situations.
  • Comfortable in working with Excel, Visio, SharePoint and any other electronic systems used in creation of Label Proof and Artwork (e.g. Adobe Illustrator, BarTender, NiceLabel, etc....).
  • Basic knowledge of functional areas and drug development process.
  • Fluency in written and spoken English, knowledge of at least another language is preferred.


Education/Experience/ Licenses/Certifications:
  • BA / BS degree Required advanced degrees preferred
  • 10+ years in Pharma industry related experience or equivalent experience
  • Relevant regulatory experience in the Pharmaceutical Industry such as cGMP, ICH, requirements with detailed knowledge of clinical trials.
  • Working knowledge of packaging and labeling industry standards such as; ISTA, ASTM, Tappi, ISO, etc....
  • Preferably 3-5-year professional experience working with packaging, labeling, and distribution.
  • Experience in supporting global clinical investigational trials from product labeling perspective.
  • Established track record of supporting IND/IMPD regulatory submissions
  • Experience managing vendors and external service providers to maintain clinical drug supply.
  • Experience managing labeling and packaging vendors.
  • Assertive in implementing industry best practices for clinical labeling of biologics and/or cellular therapeutics.


Physical Demands:
  • Position requires repetitive use of hands and wrist (computer work)
  • Occasional bending, twisting and stooping to allow for gowning into classified environment required


Work Environment:
  • Position is primarily office based with occasional work in a classified GMP manufacturing environment
  • Position is a team & project-based position that will require occasional shift work, weekends, and holidays


Travel:
  • This position may require up to 20% of travel


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.