Associate Director - Packaging Development Vial Products
This position ensures that vial and non-combination products are developed and manufactured in accordance with regulatory and customer requirements. They will be responsible for Packaging Design & Development by developing, maintaining, and improving the design controls for new drug products and lifecycle management of commercial products.
Experience / Knowledge Desired:
- Collaborate with drug development, primary container development marketing, supply chain, procurement, logistics, internal and external manufacturing sites, to successfully develop, tech transfer and launch packaged products for US and export markets that are in compliance with departmental SOPs, follow Design Controls best practices, and relevant elements of the Quality System Regulations
- Provides leadership and direction to a team of packaging engineers. Recruits and develops people to build a high performing team that model BMS behaviors.
- Sets department strategy to develop and maintain secondary packaging platforms and custom solutions for vial products
- Lead large scale commercial projects/programs in technology transfers from design center / launch site to internal BMS manufacturing sites as well as Contract Manufacturing Organizations (CMO's)
- Lead end-to-end packaging development activities from concept, development and commercialization by developing requirements based specifications through human factors engineering, conduct user studies, design of experiments (DOE's), and analysis of data using statistical tools and in-depth evaluation of variable factors.
- Implement Anti-Counterfeiting/Tamper Evidence (ACTE) platforms and custom solutions, provide input to ACTE network strategy, core team, and review board for vial products
- Provides guidance to team on development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle.
- Participate in design reviews and provide SME input. Review supporting documentation, approving documents as part of tech transfer, and ensure those documents are suitable to minimize risk to commercial manufacturing, supply, and patients.
- Participate as needed on Quality Council, Management Reviews, Packaging Technical Forum and other teams for commercially approved vial products. Compiling and developing content cross-functionally and from stakeholders as needed.
- Post-market assessment leading to identification and implementation of product design improvements. This includes component specifications, test methods, and assembly processes
- Collaborate cross-functionally to promote awareness and ensure compliance to new regulatory policies, regulations, directives, and other issues that affect vial products.
- Support root cause analysis activities for major manufacturing investigations and product complaint trends across groups in MS&T, leading investigations related to vial products. This includes forensic analysis of complaints, Design of Experiments, and application of other engineering tools.
- Support Manufacturing sites, Global Quality and Compliance in supplier, customer, internal, and/or regulatory agency audits.
- Responsible for development and maintenance of change control, document control and training systems related to packaging within finished Drug Product MS&T.
- Evaluate changes (component, product, process) post design transfer impact on manufacturing process, documentation and design control elements. Work with manufacturing site and quality, to assess risk/impact in accordance with SOPs and Design Control best practices
- Support vial product related regulatory filings pre and post approval
- Apply design controls best practices in activities in Primary Packaging, Packaging Development, Packaging Systems, and Process Engineering, with ability to flex into these adjacent areas with changing priorities.
- Responsibilities also include mentoring and developing other members of the Device & Packaging Technology team in packaging development as well as cross training to expand knowledge in other disciplines within the group.
- BS degree in Packaging Engineering or relevant engineering discipline. Advanced degree a plus.
Experience / Knowledge Desired:
- Minimum of 15 years of engineering experience in the Pharmaceutical or Biotechnology industry
- Strong analytical, technical writing, interpersonal, and communication skills with ability to present internally/ externally to suppliers, sites, health authorities, and Sr. Management.
- Thorough knowledge of quality systems regulations (21 CFR 211), validation principles for product and manufacturing processes, design transfer, engineering design fundamentals for vial products, and packaging testing (ASTM, ISTA)
- Leadership, communication and influencing skills in order to work effectively across organizational boundaries and across multiple sites/regions/levels of manufacturing sophistication.
- Demonstrated ability to:
- influence areas not under direct control to achieve objectives
- work strategically, manage multiple programs and create a high performance work environment
- work in a matrix environment and effectively support internal & external manufacturers and suppliers
- build alignment with business partners and key stakeholders
- manage risk and make rapid decisions
- budget, plan and manage resources efficiently
- Working competency of statistical programs (i.e., Minitab, SAS, etc.)
- Certified Six Sigma Green/Black belt or equivalent preferred
- Product Development Experience required
- Human Factors Engineering experience preferred
- Manufacturing Experience a plus