This is a senior scientific role in chemistry, manufacturing and controls (CMC) and nonclinical product development. The selected candidate will provide regulatory and technical leadership across investigational product manufacturing strategy, nonclinical study design and review, and product risk management for a portfolio of DoD medical products spanning drugs, biologics, vaccines, devices, and combination products. The role includes authoring and reviewing electronic Common Technical Document (eCTD) Modules 2, 3, and 4; conducting compliance site visits at clinical, nonclinical, and manufacturing facilities; and leading, mentoring, and developing a team of junior Product Technical Operations scientists. This position is designated Key Personnel under the contract Performance Work Statement. Key Responsibilities Investigational Product, Chemistry, Manufacturing and Controls Serve as the Product Technical Operations lead at the integrated product team level, providing regulatory and technical support to the development of manufacturing strategies throughout all phases of product development. Develop strategies for and execute investigational product activities, including investigational product storage, shipment, destruction, and accountability. Provide subject matter input on final formulation of the investigational product, including specialized formulation expertise where required (e.g., small molecule formulations). Assist in developing product specifications, including test lists, references to analytical procedures, and acceptance criteria. Interact with manufacturing and quality units and industry partners; attend integrated product team and partner meetings. Conduct GMP audits and provide audit reports with documentation of follow-up for Government review and comment prior to finalization (Deliverable 46) . Write, review, and revise regulatory submission documents relevant to investigational product and nonclinical efforts in eCTD format, specifically Module 2, Module 3, and Module 4 (Deliverable 47) . Review product data discrepancies found in testing records failures, deviations, Out of Specification, Out of Trend, test anomaly reports, and CAPAs and manage them to resolution through the proper Good Manufacturing Practices course of action; communicate discrepancies to ORA leadership through periodic reports (Deliverable 48) . Nonclinical Support Develop and/or review protocols and reports for Good Laboratory Practices (GLP) and non-GLP efforts, including toxicological, pharmacokinetic, and genotoxicity studies, and evaluate compliance with the designated quality system and applicable regulatory requirements (Deliverable 49) . Provide nonclinical subject matter expertise to integrated product teams and working groups across bench performance testing, biocompatibility, in vivo and in vitro studies, toxicology, pharmacokinetics, and genotoxicity; update ORA leadership as needed. Review non-clinical protocols and reports for compliance with Good Laboratory Practices. Product Strategy, Risk, and Team Leadership Create and maintain Target Product Profiles and provide them to the Government. Target Product Profiles shall address indication and usage; dosage and administration; dose forms and strengths; contraindications; warnings and precautions; safety adverse reactions and drug interactions; use in specific populations; drug abuse, dependence and overdose; description of drug; clinical and pharmaceutical characteristics; pre-clinical toxicology; clinical studies; references; storage and handling; patient counseling; risk evaluation and mitigation strategy; and supporting documentation and templates as appropriate. Conduct clinical, nonclinical, and manufacturing site visits for compliance assessment and provide site visit reports. Identify and mitigate product and manufacturing risk through a project Risk Register. Lead a regulatory intelligence working group; monitor regulatory trends and changes and proactively adapt strategies to maintain compliance. Lead, mentor, and train a team of junior Product Technical Operations scientists fostering their development, managing workloads, and ensuring alignment with organizational goals. Lead and/or actively participate in working groups for ORA process improvement, continued learning, regulatory intelligence, and quality review. Collaborate with cross-functional teams to align regulatory strategies with program and organizational objectives. Write, review, and/or revise Standard Operating Procedures. Assist in writing and/or reviewing abstracts, papers, and publications in collaboration with study team members, and support submission to all appropriate approval authorities. Required Qualifications Bachelor's degree in pharmaceutical sciences, chemistry, chemical engineering, biology, or a closely related scientific discipline. Minimum eight (8) years of progressive experience in chemistry, manufacturing and controls (CMC), product technical operations, or nonclinical regulatory support within pharmaceutical, biologic, vaccine, or medical device product development. Demonstrated experience authoring and reviewing eCTD Module 2, Module 3, and/or Module 4 content. Working knowledge of current Good Manufacturing Practices (21 CFR Parts 210/211 and/or Part 820) and Good Laboratory Practices (21 CFR Part 58). Demonstrated experience developing or maintaining Target Product Profiles, product specifications, or equivalent product development documentation. Experience conducting or supporting manufacturing, nonclinical, or clinical site compliance assessments and producing written site visit or audit reports. Experience investigating and resolving product data discrepancies (deviations, OOS/OOT, CAPAs) under a GMP quality system. Demonstrated experience leading, mentoring, or supervising scientific or technical staff. Excellent scientific and regulatory writing skills; demonstrated ability to brief senior military and civilian leadership. U.S. citizenship required; must be able to obtain and maintain the background investigation required for installation access and Common Access Card issuance. Preferred Qualifications Advanced degree (M.S., Ph.D., or Pharm.

D.) in pharmaceutical sciences, chemistry, or a related scientific discipline. Experience supporting DoD medical product development programs DHA, USAMRDC, or Army medical research environments.

Experience across multiple product types:

small molecules, biologics, vaccines, devices, and combination products. Regulatory Affairs Certification (RAC) or equivalent professional credential. Experience leading a regulatory intelligence function or working group. Familiarity with FDA regulatory submission workflows (IND, NDA, BLA, 510(k)) and the regulatory product development lifecycle. Experience with Electronic Document Management Systems (EDMS), Clinical Trial Management Systems, and DoD collaboration platforms. Knowledge of DoD 5000-series acquisition processes and Army Regulation 40-7. Prior service as designated Key Personnel on a federal services contract

Pay:

$130,000.00 - $165,000.00 per year

Benefits:

401(k) Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person