Kikiktagruk Inupiat Corporation, LLC
Process Chemistry Consultant
Closing Date: Until Filled
Department: Midnight Sun Professional Solutions
Location: USA
Employment Type: Part Time
Title: Process Chemistry Consultant
Location: Remote
Status: Part-Time
Travel: Limited Travel (anticipated 8 hours annually)
Salary Range: $100 - $150 per hour
Position Summary:
The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by contract research organizations (CRO).
Duties/Responsibilities:
- Support process chemistry efforts of preclinical and clinical programs of the small molecules under development. Consultants may be tasked with providing guidance on process endpoints, recommending assays and milestones to be incorporated into a testing funnel or development plan, and interpreting data delivered by research service contractors.
- In partnership with other Consultants, Contractors and NIH staff, advise, strategically plan, and manage process chemistry to support development of efficient and scalable manufacturing processes.
- Provide expertise in process, scale up and implementation of innovative technologies, in support of IND-enabling and clinical studies.
- Serve as the process chemistry expert in identifying potential developmental challenges and suggesting strategies to address these challenges on realistic timelines.
- Lead the chemical development activities including scale-up and process development from pilot-scale to commercial scale and technology transfer to commercial plants.
- Manage the process development technology transfer of projects at contractors' manufacturing sites.
- Oversee the writing of protocols for manufacturing scale-up batches and writing of associated process development reports.
- Lead the process chemistry activities for compounds in development in accordance with guidelines of the Federal Drug Administration and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
- Evaluate manufacturing processes and changes, and provide assessment of regulatory implications.
- Accompany NIH staff on visits or independently visit CROs under contract to NINDS. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN and/or HEAL program staff.
- Maintain current knowledge of the relevant guidelines and regulations.
- Work in a cross-functional team environment and manage competing priorities.
- Educate and build trust with LDT members of many disciplines to build consensus and maintain focus of team on milestone achievement.
- Must participate actively in LDT discussions.
- All other duties assigned.
Requirements:
- Advanced degree in chemistry or medicinal chemistry – required.
- 15+ years of process and chemical development experience; small molecules experience is required; biologics experience is a plus.
- Extensive experience in managing drug discovery and early development (e.g., Phase 1 clinical) process development efforts as evidenced by employment as an executive (senior scientific)-leader in drug discovery projects in the biopharmaceutical industry or as an experienced consultant providing the same services. Experience with drug discovery for nervous system conditions is preferred. Biologics experience is a plus.
- Experience in executing and managing drug development tasks, preferably with experience in developing drugs for nervous system conditions. Experience in Pain therapeutics is a plus.
- A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market.
- Experiences in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered indicators of a strong track record in drug development.
- Expertise leading process chemistry efforts performed by contract research organizations and managing drug project portfolios.
- Experience in the preparation and submission of the CMC components of IND [Investigational New Drug], CTA [Clinical Trial Authorization], NDA [New Drug Application], and MAAs [Marketing Authorization Application].
- Biologics experience will be considered a plus.
- Strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.
- Experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.
Apply online at our website: https://kikiktagruk.applicantpool.com/
Disclaimer:
This is not to be an exclusive list of all responsibilities, duties, and skills required of the person in this job. ?KIC is an Equal Opportunity Employer as to all protected groups, including protected veterans and individuals with disabilities.
Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders, and their Descendants.
Successful candidates must adhere to KIC's Drug and Alcohol policy/testing requirements and may be required to pass a background and/or Motor Vehicle Records check.
The salary range for this position is based on several factors, including relevant experience, education, skills, and current market conditions.??
Equal employment opportunity, including veterans and individuals with disabilities.
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