Our Global pharma client is looking to bring on board a Sr. Director, Packaging Development for their medical devices and combination products. This role is accountable for leading a team responsible for the development of packaging across product presentations. The team will be developing innovative and creative packaging solutions which meet the needs and requirements of our patients, manufacturing teams, and quality teams. Group is responsible for developing the specifications for all medical devices packaging components, along with finished combination products packaging. The team's overall focus will be on innovative packaging to enhance patient experience, reducing defect rates, and improving product safety. This position will be leading team of packaging engineers and requires extensive knowledge in pharmaceutical packaging development. Will work closely with packaging engineers to develop innovative packaging while managing due dates and project timelines. Solid understanding of packaging materials, manufacturing processes and experience in global packaging standard for the medical devices and combination products is required. The team will use a combination of principles of packaging technology, design engineering, innovation and human interface engineering. This position will provide guidance to the team for novel conceptual and innovative new packaging designs, be involved in the concept development of secondary packaging for devices to regulatory submission, and will be working very closely with the device engineering team, the human factors engineering team, device product team and product strategy partners to develop and tests design concepts. The team will work closely with the packaging engineering group(s) in Global Manufacturing & Supply (GMS) to coordinate device packaging and support product and device registration globally. The team will have the ability to explore user interface between product, device and patients, use packaging design and will ensure proper documentation to support DHF.
- Provide technical and strategic leadership and management for the development of packaging / labeling processes.
- Lead and manage functional teams, including resource management, prioritization, critical assessment of technical work, support of project teams, and developing relationships with functional partners
- Provide leadership and create strategies to evolve the capabilities of the organization in alignment with corporate’s strategies, growing health authority expectations, and changing external medical device product competitive landscape
- Influence regulatory strategies and provide guidance and reviews of regulatory information packages and filings/submissions
- Support the team to develop innovative new packaging concepts, manage packaging design activities by designing and developing, packaging solution to offer to stakeholders.
- Lead, manage and execute all aspects of a packaging project delivering early phase evaluation to stakeholders. Accountable for delivering on specific performance indicators, including but not limited to: (a) successful concept design solutions, (b) visualization of concepts and prototyping as appropriate, (c) successful human factors studies, (d) supporting regulatory submission, and (e) realistic and manufacturable design concepts
- May be the Process Owner and /or the Execution Lead, for one or more processes, including but not limited to: (i) New Device Packaging Technology Acquisition, (ii) New Device Package Introduction, (iii) Combination Product and Device Packaging, (iv) Packaging & Art-Work Specifications process including device instructions for use, (v) Packaging Process Development including demonstration and starter kits
- Ensures proper level of documentation and covers packaging related DHF aspects
- Serve as an early concept Package Engineer to the Device Product Technical Teams
- Represents device development and external manufacturing on development teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.
- BS + 15 years experience, or MS + 13 years experience, or PhD and/or MBA + 10 years experience.
- Chemical Engineering or other relevant Engineering field, Pharmaceutical Sciences, or related field with related experience in the biopharmaceutical industry.
- Strong technical and scientific skills with proven experience in development of drug product manufacturing processes and/or packaging solutions for biologics in primary containers and devices.
- Direct experience in packaging partner / contract packaging development and mfg. is required.
- Proven track record of leading and driving global scale business process transformation and organizational culture change as well as delivering on programs with complex business deliverables is a plus.
- Track record of successful leadership, management, and development of teams is required.
- Proven knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document (e.g., ISPE, PDA, ASTM, ISO, ICH, Pharmacopeias) and Regulatory combination product guidance documents applicable to the role. Strong problem solving skills, excellent communication and cognitive skills, proven capabilities in Computer Aided Designs (CAD) and Product Development rendering skills.
- Good understanding of manufacturing process and packaging constructions methods. Ability to work in team, fulfills commitments and managing multiple stakeholders. Experience in drafting portions of combination product technical content. Proven ability to author user requirement specifications, technical protocols, reports and assessments. Previous project team experience with technology transfer. Hands on experience with the concept development and feasibility testing.
- Experience in global product launches and the associated CMC regulatory requirements.
- Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.