Join Impel

ACCOUNTABILITY OBJECTIVE:

The Research Associate II will provide analytical chemistry support in Impel’s Analytical & Translational Sciences group. Impel’s product development team is a technical, driven and highly-collaborative group focused on introducing the best products possible into the market. As a Research Associate II, this team member will contribute to product development through the development of methods for analytical testing of drug-device combination products and by carrying out routine stability testing on Impel’s products in development.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

• Hands-on laboratory bench work and sample testing supporting development of pharmaceutical products. This includes but not limited to performing HPLC assay and related substances testing, dose and spray content uniformity, device performance testing, particle size distribution and other tests to characterize and demonstrate product performance.
• Conduct laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing and dilution, sample handling and processing, instrumental analysis using HPLC, UV-visible spectrophotometry, loss on drying, Karl Fischer, DSC, particle size distribution, and other analytical techniques as required.
• Conduct and troubleshoot analytical methods for testing raw materials and products.
• Follow protocols and methods for the transfer and/or qualification/validation of analytical methods as necessary for development of pharmaceutical products. Implement the method qualification/validation. Summarize the results in the lab notebook and reports.
• Maintain a laboratory notebook in high fidelity.
• Contribute to lab maintenance/housekeeping, documentation, and training tasks as necessary.
• Other general laboratory tasks as assigned.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Bachelor’s degree in Chemistry or related field with 2+ years of industry laboratory experience and hands-on experience conducting experiments with HPLC of small molecules
• Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems
• Knowledge of working in a GLP and GMP environment
• Execution of daily activities with extreme attention to detail and ownership
• Outstanding organizational skills, ability to manage and complete tasks on time
• Proven ability to adapt and respond to the needs of a growing organization conducting R&D activities; communication and interpersonal skills are emphasized
• Familiarity with Microsoft Office Suite and Internet based office applications
• Ability to understand complex instructions and carry out procedures complying with instructions
• Ability to record and tabulate data; meticulous record keeping in the laboratory notebook

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• This position will require periods of standing in a fast-paced laboratory area to assist in the completion of testing and maintenance. Periods will range from 15 min to several hours standing to fulfill tasks.
• Must be able to lift 40 lbs. Received shipments of solvents and pharmaceutical products in development will require storage and careful moving in the laboratory to avoid spills.
• The technician must be able to lift 4L bottles of solvent to pour from one vessel to another to prepare solutions. Spills are to be avoided to protect the safety of the technician and the laboratory staff.
• May be responsible to move items to assess inventory in busy laboratory area for potentially prolonged periods of time.
• Ability to use computer, telephone, and other office machines.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Carts and lifts are available to help as needed.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.

TRAVEL

Up to 10% travel is anticipated.

ACCOUNTABILITY OBJECTIVE: 

In this key role, the TMF Specialist is the subject matter expert for activities that ensure contemporary, complete, and accurate Trial Master Files through documentation quality and consistency across clinical trials and programs. The TMF Specialist collaborates closely with the PM or equivalent for all trial master file responsibilities conducted internally as well as externally with Contract Research Organizations (CROs). The TMF Specialist will provide crucial TMF quality support to the Study Team and is expected to establish a proactive quality-focused partner-relationship with the Study Team.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:

• TMF management/vendor management
• Facilitate the creation of study specific TMF management tools
• Develop and maintain TMF Management Plans, TMF Content Lists/File Plans, TMF Comprehensive Review tracker and TMF-related risk assessments in collaboration with study teams
• Participate in the Quality Control process for documents (paper and electronic) submitted to the TMF or eTMF
• Facilitate the review and submission of TMF records to TMF
• Coordinate or support the coordination of the transfer of study-specific trial master files from the CRO per Impel SOP(s)
• Participate in Study Team meetings and provide/present regular TMF metrics updates: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by Impel management
• Maintain awareness of study events and manage the associated documentation requirements, including collection/inclusion, through collaboration with Study Team and 3^rd party vendors
• Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations
• Act as point person for Study Team TMF questions and manage close-out of TMF related issues
• Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
• Identify risk(s) associated with TMF process and any corrective actions which must be addressed and assigned
• Support the submission of documented evidence of the TMF Quality Review to the TMF
• Support the management of TMF documentation issues throughout the lifecycle of an assigned study
• Collaborate with Quality Department to support and carry out processes associated with Records Management
• Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of TMF related activities
• Provide guidance on best practices for TMF record handling, retrieval and archival procedures
• Provide archived Impel records to users (e.g. internal staff and/or Auditors) for review
• Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
• Respond to TMF internal and/or external information inquiries related to Impel TMF records
• Participate in the development, implementation, and maintenance of TMF classification and filing systems per administrative, research, regulatory, and quality requirements
• Manage and oversee contract vendors for off-site storage/archiving of Impel TMFs
• Support the implementation maintenance of Impel’s eTMF system
• Support /oversee daily Trial Master File management activities such as Review, Processing, Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready of Impel’s eTMF system

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Bachelor’s degree preferred
• A minimum of 5 years of experience working within the TMF (includes CRO / Vendor experience)
• 2 plus years Pharma experience (includes CRO / Vendor experience)
• Strong knowledge ICH/GCP documentation requirements
• Experience with eTMF systems, preferably Montrium Connect and Veeva Vault
• Experience with managing clinical study documentation
• High attention to detail
• Excellent organizational skills
• Experience with MS Office
• Excellent verbal and written communication skills
• Able to demonstrate a flexible, proactive, diligent and self-motivated approach to work

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Must have demonstrated ability to multitask in high pressure, changing conditions.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level. Limited travel may be required.

ACCOUNTABILITY OBJECTIVE

As the Director, Supply Chain you will direct and manage the global acquisition, supply, and distribution of commercial products to achieve business objectives.  You will operate at the highest levels of decision making related to combination product component, drug, and packaged product planning, acquisition, inventory management, shipment, and supply to Impel’s 3PL.  The ideal hands-on candidate demonstrates a passion for excellence, is detail oriented, timeline driven, has a positive attitude, can rapidly adapt and pivot, is organized, collaborative across multiple disciplines, multi-tasks, and can deal with ever changing priorities.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned as appropriate.

• Lead the collective supply for all Impel commercial products including
  • Commercial forecasting, demand planning and management of commercial drug and device supplies
  • Management of the commercial supply, including device component suppliers and assemblers, drug manufacturers, co-packaging suppliers, serialization and 3PL distribution of product.
  • Effective function across the continuum of pre-commercial to commercial lifecycle and can create and lead supply chain relationships in consideration of the stage of the program.
• Develops departmental structure, function, and personnel to deliver upon necessary departmental and company Key Performance Indicators.
• Accountable for the S&OP process and the commercial supply chain, directing, driving and facilitating decision making for this process across all Impel programs.
• Assess and communicate risk and opportunity related to the global supply of commercial product.
• Oversee global logistics, product packaging for shipment, and material movement and inventory by CMO.
• Participate on and support product development teams to ensure supplies are provided to achieve key performance indicators.
• Interacts and aligns department function with Impel’s New Product Introduction teams.
• Establish processes to efficiently manage material control at Impel’s suppliers.
• Develops and manages annual departmental budgets for inventory, materials, and logistics within the Commercial Supply function.
• Oversee import/export brokerage relationships and process
• Establish and oversee third party logistics firm(s) for distribution and fulfillment of Impel’s commercial products.
• Establish and oversee implementation and maintenance of serialization compliant with DSCSA at identified CMOs.
• Own and implement the MRP system and process within Impel
• Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained within the approved supply chain.
• Develops and publishes metrics to communicate and manage the effectiveness of the Commercial Supply function leading to increased efficiency, cost reduction and improved customer service.
• Identifies areas for improved efficiency and drives cost reduction for commercial programs through appropriate means.
• Interacts with Finance to ensure alignment of product costing and all financials within the ERP system.
• Assists in developing logistics relationships, plans and procedures.
• Establishes and maintains 3PL relationships, setup, and the ongoing relationship throughout the product lifecycle.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Bachelor’s degree in Business, Finance, Logistics or Engineering.
• Minimum 10 years of related Operations and/or Commercial Supply experience in a fast paced, progressive pharmaceutical, biotech, medical device or other regulated environment. An advanced technical degree or MBA is preferred.
• In-depth, direct experience with the implementation and use of commercially available MRP/ERP systems.
• Deep knowledge of demand planning and experience in participating in, or preferably managing, the S&OP (or SIOP) process.
• Understanding of the end to end Supply Chain and interdependencies across all corporate functions. The ability to collaborate across all levels of the organization and Supply Chain.
• Proven experience in developing and nurturing relationships with critical manufacturing partner in the pre-commercialization and commercialization phase.
• Experience in the successful commercial launch and management of pharmaceuticals, medical devices or combination products.
• Experienced in developing, coaching, guiding and leading a team in the execution and development of strategies to achieve company Key Performance Indicators.
• Experience with best practices related to supply, inventory management and 3PL distribution for commercial products.
• Direct knowledge of import/export regulation as it pertains to FDA regulated products is highly preferred.
• Must be proficient in Microsoft Office and Visio. Proficiency with Business Central, Microsoft Project or Smartsheet is preferred.

CULTURAL COMPETENCIES

• Collaborative: Works together in an intersection of common goals by sharing knowledge, learning and building consensus with others.
• Flexibility: Develops new or diverse strategies to achieve organizational goals. Able to lead in a changing and challenging work environment. Manages competing demands and unexpected events.
• Ownership: Demonstrates full ownership and takes accountability for the actions and execution of both self and the department.
• Leadership: Proven ability to lead diverse project teams without managerial responsibility for them.
• Initiative: Measures self against a standard of excellence. Demonstrates persistence and overcomes obstacles, takes calculated risks to accomplish goals. Ability to work a demanding, primarily self-directed work schedule.
• Professionalism: Works well in a fast-paced environment; treats others with respect and consideration; accepts responsibility for own actions. Understands business implications of decisions, aligns work with strategic goals. Meets deadlines and commitments.
• Communication Skills: Clearly and persuasively communicates verbally and in writing. Listens and seeks clarification; manages difficult situations; maintains confidentiality.
• Problem Solving: Conducts appropriate analysis and makes clear, consistent, and timely decisions.
• Detail minded: Demonstrates accuracy and thoroughness; monitors own work to ensures quality and organization. Strong attention to detail while multitasking.

PHYSICAL DEMANDS

Must be capable of lifting packages under 50 lbs.  Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

WORKING CONDITIONS

This is a fast-paced open office environment with moderate noise level.

TRAVEL

Estimated at up to 30%, domestic and international (Europe) is anticipated