Drug Discovery and Development Consultant - Pharmaceutics Formulation/CMC - Military veterans preferred

Kikiktagruk Inupiat Corporation, LLC

Drug Discovery and Development Consultant - Pharmaceutics Formulation/CMC
Closing Date: Until Filled
Department: Midnight Sun Professional Solutions
Location: USA
Employment Type: Part Time

Title: Drug Discovery and Development Consultant - Pharmaceutics Formulation/CMC

Location: Remote

Status: Part-Time

Travel: Yes (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 CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

Pharmaceutics Formulation/CMC Consultant shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

Pharmaceutics Formulation/CMC Consultant is expected to provide support services in a collaborative way. Lead Development Teams the Pharmaceutics Formulation/CMC Consultant is assigned may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

Duties/Responsibilities:

• Evaluate Pharmaceutics / Formulation / CMC activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines.
• Identify and assess regulatory risks for compounds under development and provide CMC guidance to the BPN program and LDTs.
• Develop Pharmaceutics / Formulation / CMC strategies which accord with U.S. and international guidelines.
• Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules.
• Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules.
• Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency (EMA) and other national authorities, to support the conduct of clinical trials and marketing applications.
• Provide expertise in activities related to active pharmaceutical ingredient (API) development.
• Recommend dose form selection and API development strategies for BPN efforts.
• Develop plans to assist BPN staff in strategically managing chemical manufacturing and control pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.
• Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff.
• Assist BPN staff in designing investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed.
• Facilitate Lead Development Team discussions via telephone and email regarding Pharmaceutical formulation / CMC efforts.
• Work in a cross-functional team environment and manage competing priorities.
• Must participate actively in LDT discussions.

Minimum Requirements

• Advanced degree in a life or physical science discipline – required.
• 15+ years of senior scientific level experience in pharmaceutics formulation / CMC activities – required.
• Experience in executing and managing drug development tasks, preferably with experience in developing drugs for nervous system conditions.
• A track record of advancing projects into drug development. Measures of success include Investigational New Drug (IND) applications, publications, and drugs brought to market.
• Experience 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 as signs of a strong track record in drug development.
• Extensive experience leading CMC efforts performed by contract research organizations.
• Experience managing drug project portfolios.
• Experience in small molecules and biologic therapeutics will be considered a plus.
• Extensive experience in managing, or being a senior leader in, drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred.
• Extensive experience in managing drug discovery and early development (e.g. Phase 1 clinical) CMC 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.
• 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.
• Strong interpersonal skills, attention to detail, excellent organizational, writing, communication, presentation, and documentation skills, as well as computer and software literacy.

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.??

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