Join Impel

Responsibilities include the following.  Other duties may be assigned.

• Lead scientific, technical, and business-related risk assessments to assist in CRO selection and evaluations, including leading and managing the Request for Proposal process
• Perform CRO on-site assessments of CROs for pharmacokinetics, toxicology, safety pharmacology, and developmental and reproductive toxicity studies

• Design, supervise, analyze, interpret, and report in vivo non-GLP and GLP studies conducted at CROs including PK, toxicology and safety pharmacology studies in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation and record keeping are compatible with global regulatory submission requirements.

• Work collaboratively with CROs and internally across-disciplines to coordinate study timelines and deliverables
• Accountable for critical documents including study protocols, reports, nonclinical sections of regulatory documents. May contribute to manuscripts and regulatory submissions.
• Candidate should have strong critical thinking and research skills and a desire to conduct early development /mechanistic studies as well as GLP-compliant IND enabling toxicity studies.
• Develop and maintain cross-departmental collaborations and shared work practices across functional groups and participate in project teams.
• Contribute to departmental processes such as SOPs and templates.

Qualifications

• Ph.D. in Pharmacokinetics/Pharmacology/ Toxicology/ Biological Sciences or related discipline with 2+ years of biotech, pharmaceutical industry or CRO experience; MS +5 years experience or BS with +8 years experience.
• Demonstrated comprehensive knowledge of designing, conducting and interpreting nonclinical PK, PD and toxicology studies.
• Strong knowledge of nonclinical drug development, FDA and ICH guidances, and GLP regulations.
• Direct experience working on multidisciplinary drug development project teams and comprehensive knowledge of drug development strategy.
• Outstanding organization and planning skills, and the ability to multi-task and understand project team deliverables.
• Proficient at critically reading and applying relevant scientific literature.
• Excellent analytical and soft skills to interact effectively and harmoniously with vendors and stakeholders.
• Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit.
• Demonstrates a sense of urgency, proactive and creative thinking, and productivity in a fast-paced, innovative and team-oriented environment.
• Travel required up to 30% per year to monitor outsourced studies (domestic and international.)

As a member of the Analytical Sciences team, this role will support early and late stage 505(b)(2) small molecule drug development programs at Impel. Specifically, the individual will lead all outsourced analytical chemistry efforts on designated projects in alignment with the cross-functional development team. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are critical for success.

Responsibilities include the following.  Other duties may be assigned.

• Serve as the lead scientific and technical expert to assist in evaluations of GMP testing facilities, including leading and managing Request for Proposal process for the Analytical Sciences group
• Perform on-site assessments of CROs for GMP testing capabilities of drug substance, drug product and drug-device combination products
• Guide testing laboratories to develop, validate and transfer analytical methods suitable for progressive stages of pharmaceutical development
• Work with internal Analytical Sciences team to leverage in-house capabilities to reduce time and cost spent on outsourced development and non-GMP activities
• Design validation protocols that are in compliance with ICH and FDA guidelines, and identify critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
• Together with the CMC cross-functional team, set and justify drug substance and drug product specifications with the understanding of clinical study design and CMC processes
• Justify and set retest period, storage, and shipping conditions
• Understand chemical development, solid state development, and formulation development to identify and document critical factors that impact method performance and/or analytical development activities
• Work alongside Drug Development & Manufacturing team to identify critical in-process-control issues and develop appropriate IPC methods
• Design, oversee, analyze and interpret stability study results for drug substance and drug product
• Timely monitor and evaluate release and stability data from CMOs and CROs for GMP compliance, potential out of specification, out of trend, and method performance issues and supervise or conduct investigations and implement corrective actions as needed
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions
• Develop, review, and approve source documents for regulatory submissions

Qualifications

• Ph.D. in Analytical Chemistry, Organic Chemistry or related field with 5+ years of relevant analytical development experience; MS with 8-10+ years of experience; supervisory experience a plus
• Broad understanding of the drug development process, including clinical design, toxicology, regulatory filings, chemical development, solid state development, and formulation development, and the interrelationship with analytical development is essential
• Demonstrated knowledge of ICH, FDA, and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
• Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, and broad knowledge of other techniques used in pharmaceutical analysis; experience with nasal spray or MDI/DPI product testing a plus
• Outstanding organization and planning skills, and the ability to multi-task and understand project team deliverables
• Proficient at critically reading and applying relevant scientific literature
• Excellent analytical and soft skills to interact effectively and harmoniously with vendors and stakeholders
• Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit
• Demonstrated leadership skills, a sense of urgency, proactive and creative thinking, and productivity in a fast-paced, innovative and team-oriented environment
• Travel up to 30% (domestic and international)

ACCOUNTABILITY OBJECTIVE:

The primary responsibility for this position will be managing/directing the Clinical QA activities to support GCP and Clinical Trial obligations.

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

• • Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
  • Lead investigations and write CAPAs on GCP issues as they arise.
  • Ensure proper maintenance of the Quality systems.
  • Directly interface with Clinical Operations to provide support for vendor, site, and internal GCP audits.
  • Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
  • Responsible for ensuring submission data and documentation meets GCP guidelines.
  • Perform and/or support audits of clinical sites, CROs and other clinical vendors.
  • Assist in authoring clinical operation SOPs and processes as needed.
  • Develop and support established records management procedures.
  • Provide input and change management for quality improvements affecting CQA systems.
  • Assist with writing and editing documents needed for the clinical quality management system.
  • Update and maintain CQA SOPs that support the quality systems.
  • Manage and update electronic libraries.
  • Facilitate meetings with CRO’s and other clinical entities as appropriate.
  • Ensure Trial Master Files are maintained within standards.
  • Other duties as assumed or assigned.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• • Bachelor’s degree
  • Education and experience in an FDA-regulated environment.
  • Ten (10) years of related quality or clinical experience in a similar environment.
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
  • Demonstrates initiative and proactively provides collaborative support to the clinical teams.
  • Ability to plan and organize work in an efficient manner and work well under time constraints.
  • Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
  • Must have experience using MS Office
  • Experience in MasterControl or a similar ECM system is a plus.
  • Willing to travel 20-30%.

PHYSICAL DEMANDS

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

WORKING CONDITIONS

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. Ability to use computer, telephone, and other office machines

ACCOUNTABILITY OBJECTIVE:

The PK Scientist – Modeling & Simulation will be a key team member of the Translational Sciences team and will work closely with the Regulatory and Clinical Operations teams. This individual will independently and creatively use modeling and simulation tools to enhance quantitative decision making. The modeling and simulation activities include non-clinical and clinical modeling and simulation, including but not limited to, population PK/PD models, translational models, clinical trial simulations, literature meta-analysis, and other innovative, state-of-the-art modeling and simulation techniques.

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

• Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
• In depth, hands-on knowledge and experience with modeling and simulation software and applications in the area of PKPD modeling, simulation and statistics (Phoenix WinNonlin, Phoenix NLME, NONMEM or comparable applications)
• Lead all modeling and simulation efforts at Impel and bring a solid understanding of the principles of pharmacokinetics (non-compartmental, compartmental, PBPK) and biopharmaceutics to the team
• Build on solid foundation of quantitative skills to develop mechanistically-relevant PK-PD models
• Drive to the understanding of the covariates that contribute to variability in PK and/or PD
• Translate/condense/summarize outcomes of modeling and simulation analyses into information that can be used by project teams, presented internally or externally
• Support comparative BA and BE clinical study design through PK modeling and statistical assessments
• Conduct clinical trial simulations
• Conduct simulations to characterize PK/PD in special populations (pediatrics) and translational models
• Contribute to pre-INDs, INDs, NDAs and work closely with the Regulatory team on submissions

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Ph.D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biostatistics or similar disciplines where modeling and simulation is emphasized
• 5+ years of industrial experience in practical applications of modeling and simulation is required
• Independent, self-starter, positive attitude
• Creative problem-solver and ability to efficiently and effectively implement models at Impel
• Highly organize and outstanding written and oral communication skills
• Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of PK-PD modeling and simulation
• Advanced understanding of the global drug development process and collaborations among multiple functions from discovery to commercialization

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. Ability to use computer, telephone, and other office machines.

WORKING CONDITIONS

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

Up to 10% travel may be required.

Impel Neuropharma seeks to address unmet needs for people managing CNS disorders. We are developing medications that achieve improved outcomes via our intranasal delivery platform – Precision Olfactory Delivery or POD™. Our proprietary nasal drug delivery device ensures consistent and predictable drug delivery in an easy to use device for patients. We have active development programs to address patient needs in migraine, Schizophrenia, Parkinson’s disease and other CNS disorders. We strive to create life-changing, innovative therapies for CNS diseases.

ACCOUNTABILITY OBJECTIVE:

Impel is a virtual manufacturing company — all manufacture and supply is outsourced to suppliers. This position provides outstanding customer service to Impel’s combination product development programs by ensuring timely and technically rigorous implementation of new designs into manufacture at Impel’s Contract Manufacturing Organization(s) (CMO) and component suppliers. The Sr Manufacturing Engineer leads the technical coordination, development, and review of manufacturing related activities. This role is responsible for the manufacturing technical transfer of design into clinical and commercial manufacture as well as supporting existing manufacturing capabilities. Specific focus on injection molding, semi-automated, and automated assembly lines.

The ideal candidate has a positive attitude, is flexible, organized, multi-tasks, collaborative, can deal with ever changing priorities, and enjoys learning new ways to provide value to the organization. The Sr Manufacturing Engineer delivers high quality processes and products to program deadlines.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

·       Owns technical manufacturing development within Impel’s project team

·       Acts as point of contact for manufacturing related issues. Leads internal and external team efforts to resolve manufacturing issues through application of experience, technical knowledge and skill.

·       Defines and manages Impel’s approach to manufacture and scale up including appropriate use of resources to achieve product target timeline and cost

·       Manages supplier development of manufacturing tooling and equipment ranging from low volume manual manufacture to high volume automated manufacture and packaging

·       Owns manufacturing improvement process – track metrics, propose improvements, execute or manage implementation

·       Acts as conduit between Impel and virtual contract manufacturing lines – provides internal reporting to Impel teams

·       Develop Impel’s metric tracking tools to focus efforts where they bring the most value

·       Evaluates technical capability and contributes to the CMO selection process.

·       Develops Impel’s manufacturing capacity to support manufacture of Impel product, clinical through commercialization.

·       Supports project teams by participating in the planning, maintenance, and development of new, modified and/or existing manufacturing activities conducted at CMOs.

·       Maintains adherence to medical device quality standards and regulations, with emphasis on CMC activities.

·       Works closely with the Quality Assurance group to ensure that manufacturing operations at Impel’s CMOs are in control and are appropriately monitored.

·       Ensures thorough and adequate PFMEAs are developed for all respective processes

·       Identifies and mitigates risks associated with manufacturing processes

·       Plans and defines design transfer requirements in accordance with 21 CFR 820 for combination products

·       Supports manufacturing process validations

·       Keep key stakeholders apprised of impending manufacturing activities and challenges

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Bachelor’s degree is required.
• Minimum 5 years of experience as a Manufacturing Engineer, Assembly Process Engineer, and/or Plastics Tooling Engineer in a fast paced, multi-project, progressive environment
• Must be proficient in Microsoft Office products, Proficiency with Microsoft Project or Smartsheet is a plus.
• Outstanding communication skills
• Working knowledge of standard manufacturing metrics and methodologies – SPC, OEE, lean, six sigma, etc.
• Positive team player, willing to step in and fill identified project team gaps
• Must be capable of continuous learning and have a desire to take on an ever-changing list of tasks.

PREFERRED SKILLS

• Thorough grasp of tool qualification, process validation, process control and FDA 21 CFR 820 manufacturing requirements.
• Previous experience with contract manufacturing
• Experience in regulated environment – medical, aerospace, nuclear
• History of both implementing new manufacturing lines and supporting legacy lines
• Lean manufacturing implementation
• Solidworks or other parametric solid modeling capability

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 environment with moderate noise level.

TRAVEL

Up to 25% travel is anticipated.

 ACCOUNTABILITY OBJECTIVE:

This position will research regulatory strategies, draft, edit, format, and finalize in coordination with Regulatory and other disciplines as required, regulatory feasibility reports, FDA meeting request letters, meeting packages, package inserts instructions for use, and sections of IND or NDA submission documents. Other documents may include publications, “White Papers”, position statements, abstracts/presentations and other regulatory materials as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide research to support regulatory documents including data output
• Incorporate internal and external data into strategic regulatory documentation
• Perform literature searches related to documents and presentations in development; and in support of other departments
• Support the generation of Meeting Request Letters, Meeting Packages, and other regulatory documentation such as Fast Track or Orphan drug submissions
• Support the preparation of Target Product Profiles and transition to Package Inserts and Instructions for Use
• Support the generation of sections of IND or NDA dossiers for submission to the Regulatory authorities
• Perform other duties as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Advanced degree (MS, MD or PhD) in a relevant scientific field
• 5+ years documented medical or scientific writing experience in academia, pharma, biotech or a CRO setting
• In-depth knowledge of Good Clinical Practices, FDA regulations, MHRA regulations, ICH guidelines and the drug development process
• Familiar with principles of Good Documentation Practice
• Strong computer skills (Word, Excel, PowerPoint, and Adobe Acrobat) and the use of templates
• Excellent written and verbal communication skills, with the ability to clearly present clinical data
• Strong organizational skills with the ability to effectively multi-task and prioritize
• Flexibility/adaptability to working in a fast-paced and dynamic environment and to changing business needs and deadlines
• Strong attention to detail and ability to complete writing assignments in a timely manner
• Ability to work independently and collectively in teams

PHYSICAL DEMANDS 

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

WORKING CONDITIONS

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. Ability to use computer, telephone, and other office machines