Supervisor Packaging & Labeling (Onsite)

Purpose and Scope

The position will provide supervision and direction to the Engineering Coordinators on the Packaging and Labeling team. In addition, this individual will function as a subject matter expert (SME) in the product life cycle management (LCM) of device, packaging, and labeling constituents as part of combination product programs. Lead and facilitate the resolution of highly complex technical issues to ensure the on-time delivery of high quality, safe and regulatory compliant products.

Responsible for developing and implementing best practices to achieve artwork process and product development efficiencies that result in reduced product development cycle times.

Accountable with the technical robustness of product designs in development and lifecycle management of on-market combination products. Manage change controls, manufacturing process validations, device product complaints, regular review of Design History Files (DHFs), and support of post-market surveillance activities for on-market products.

This individual will interface with multiple functional teams including Manufacturing, Marketing, Program Management, Quality, Regulatory, and Supply Chain, from Stage Gate 5 (submission/approval) through commercial LCM. The role will supervise the team responsible for commercial labeling and manage technical development of device/packaging constituents of Combination Products in collaboration with external partners and suppliers.

Essential Duties & Responsibilities

• Supervise the cross-functional Labeling team as a Labeling Strategy subject matter expert for the creation and update of labeling - for alignment and communication of labeling text at product launch.
• Hands-on device development technical lead/contributor and SME, provide project and technical leadership from "Concept" to "Design Transfer" in accordance with Tolmar's Product Development Process.

• Raise and manage change requests for labelling updates (instructions for use and product/packaging labels) and coordinate with relevant stakeholders and action item owners, driving changes from planning phase to closure in an effective manner.
• Coordinate with other departments involved, such as regulatory affairs, production/ operations, logistics, Marketing Partners, and others for artwork and labeling.

• Supervise the development of Design Assurance documentation to ensure compliance with 21CFR 820.30, Tolmar Operating Standard for Device Design Control (PS-00012), and Risk Management for Medical Devices (ISO 14971) regulations.
• Responsible for device/packaging verification work packages including functional and performance evaluations, simulated transit studies, container closure integrity, material characterization and sterility compatibility in support of Combination Product development efforts.
• Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to user needs and value creation.
• Supports the continuous improvement of initiatives across the End-to-End labeling process.
• Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.
• Assess and recommend instruments and equipment to acquire to enhance device, packaging, and labeling capabilities.
• Communicate effectively on project status, risks, issues, and accomplishments at multiple organizational levels.
• Influence and educate cross-functional stakeholders and leaders on combination product development and commercialization best practices.

Knowledge, Skills & Abilities

• Working knowledge of the following standards and regulations:




• Quality System Regulations for Medical Devices - 21CFR820 and ISO 13485
• Risk Management for Medical Devices - ISO 14971
• Physical test method development, qualification, and validation
• Other industry standards applicable to device constituents of combination products

• Ability to align and manage multiple projects simultaneously and achieve scheduled milestones; demonstrate risk project management including contingency planning.

• Strong understanding and experience in design controls, risk management and failure investigations.

• Laboratory equipment and techniques for drug delivery device development and testing
• Experience in leading continuous improvement and LCM activities by driving the implementation of process and product quality improvement initiatives.
• Knowledge in developing and maintaining Design History Files (DHFs).
• Working knowledge of Combination Product Development processes and requirements.

• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Strong oral and written communication skills, decision making, presentation, and organization skills.
• Capable to collaborate and converse technically with diverse partners such as SMEs from Formulation Development, Clinical, Analytical Development, Manufacturing, Marketing, Program Management, Quality and others.
• Capability to prioritize and advance multiple projects in a fast-paced environment.
• Able to navigate ambiguity and provide a structured problem-solving approach.
• Organizational savvy and presence to form effective relationships across functions.
• Working knowledge of MS Office tools (i.e. MS Project, etc.)

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor, Master's or PhD Degree in Engineering or technical degree (Biomedical, Chemical or Materials Science and Engineering).
• At least four (4) years of medical device or combination product development experience.
• In depth understanding of Risk Management methodologies for medical device development.
• Knowledge of pharmaceutical labeling is a plus.
• Proficient with statistical techniques.
• Experience with navigating regulations for medical device or combination products.
• Understanding of the requirements (GMP, Validation, CFR, etc.) applicable to working within a regulated industry.

Compensation and Benefits

• Annual pay range $105,000 - $115,000
• Bonus eligible
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment.
• Occasional weekend and/or evening work may be required.
• Must be capable of lifting up to 35 lbs.
• Must possess a valid driver's license and an acceptable MVR.
• International & Domestic travel up to 5% of time may be required.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.