Engineering / Facilities

Sr. Director, Packaging Development Direct Hire MA

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Job ID: 16375 Direct Hire MA

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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.

Responsibilities: 

  • 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.

Requirements:

  • 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.

Packaging Manager - Combination Devices Direct Hire MA

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Job ID: 16356 Direct Hire MA

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Our global pharma client is looking to add onto to their elite Device Development team in the Waltham, MA area and bring on-board a Packaging Manager!  This is a role that will have both site and global insight and be a critical influencer on the development and selection of Container Closure Systems for their drug combination devices.  This role will manage cross functional teams and develop innovative new primary packaging concepts (CCS), qualify and implement optimal and cost-effective primary packaging solutions that offer best in class process efficiency to operations in the different Operation Sites.  In addition, will work very closely with the device development, packaging engineers and drug product groups to coordinate all aspects for primary packaging.  Manager will be highly involved with the development and launch of primary packaging components; assess, develop, design, specify, test and implement primary packaging solutions at external and/or internal manufacturing sites. Additional responsibilities include CCIT deliverables and resolving manufacturing issues.  Other responsibilities include but not limited to:

  • Develop innovative new concepts for primary packaging, qualify and implement CCS solutions
  • Manage primary packaging activities including developing, qualifying and implementing of CCS
  • Provide guidance to the laboratory for the testing of CCS and development of CCIT methods
  • Lead, manage and execute all CCS aspects of a project. Accountable for delivering on specific performance indicators
  • Will work with internal stakeholder to create or enhance primary packaging capabilities to deliver the needed quality required by our patients
  • Will partner with packaging engineering group to ensure quality in product packaging and drive elimination of customer complaints relating to packaging
  • Serve as a Point of contact for Primary Packaging aspects to the Product Technical Teams
  • Support protocols development for the feasibility testing
  • Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects.
  • Represents device development and external manufacturing on
  • Investigate new sources and make recommendations on primary packaging materials and support material change and implementation.

Requirements:

  • Bachelor’s degree in a scientific/technical discipline with a minimum of 8 years related experience. Applies expert knowledge of scientific/technical principles and concepts in managing technical programs such as Package design development for primary packaging systems
  • Familiar with CCIT methods such as dye ingress, head space analysis, vacuum decay, and high voltage leak detection
  • 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.

Packaging Engineering, Cell & Gene Therapy Direct Hire MA

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Job ID: 16315 Direct Hire MA

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Are you an expert in Packaging Engineering for biotech, pharmaceutical, gene therapy or medical device products?  Do you have experience with shipping qualifications, defining suitable label stocks, defining specifications for labels, etc.?  If so, this is an opportunity you can't pass up!   

Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This role is with a mid-size company and they have a culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

The main function of this role is to lead efforts to align and optimize primary and secondary packaging solutions based on operational requirements for cell & gene therapy products and define and implement robust processes and procedures for developing and managing labeling processes.

Responsibilities include but are not limited to;
•  Lead the design, development, implementation, and maintenance of primary, secondary and tertiary packaging for viral and cell therapy products and intermediates
•  Manage relationship with Cold Chain and Packaging vendors and provide oversight of packaging and labeling activities at internal and external manufacturers/CMOs
•  Lead qualification activities for all shipping systems for Cold Chain materials
•  Development of packaging User Requirement Specification (URS) documents 
•  Integrate regulatory, technical, and branding requirements into the design of compliant Cell Collection, Drug Product labels used for domestic and international clinical trials and commercial markets
•  Support product traceability system at clinical and commercial collection centers and external manufacturers
•  Lead change management processes for labeling, including the development or revision of Label Specifications & Label Proofs
•  Support activities related to selection and implementation of labeling stock at CMO’s 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in in Engineering or Packaging Science and 5-10+ years of experience in a GMP environment.  Title will be commensurate with experience and the Hiring Manager is open to individual contributors and those with previous management experience.  Excellent interpersonal, verbal and written communication skills are required for this role.  Qualified candidates must be able to demonstrate a history of working cross-functionally with internal groups (Regulatory Affairs, Artwork, etc.) and with external vendors, partners or CMOs.     

Must be authorized to work in the US indefinitely to be considered. This role is based in Cambridge.  Unfortunately, remote-based employees can not be considered at this time.  Relocation assistance may be available for qualified candidates.   

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.