Friday, August 13, 2021 9:40:16 AM
Director of Drug Product Development to lead drug product development with a focus on lipid based formulations. The individual will play an essential role in cross-functional teams and will be responsible for driving activities related to drug product process & manufacturing development. The primary responsibility will be for a mid/late-stage product development and NDA preparation. The responsibilities include process development and optimization of the technical operations associated with lipid based suspension and oral drug products and process characterization. This position will report to the Vice President, Manufacturing & Supply Chain.
Responsibilities
Ensures all drug process development and manufacturing development activities for drug products are aligned with Matinas BioPharma's project goals and timelines.
Design and execute various studies to support process selection and manufacturing unit operations including stability and excipient selection, freeze/thaw, mixing, filtration, bottle filling and spray drying,
Lead/manage DOE and risk assessments to finalize the DP formulation and manufacturing processes.
Works collaboratively with internal stakeholder functions such as Clinical Manufacturing, Project Management, Clinical, and Regulatory to meet program goals. Coordinates seamlessly with colleagues overseeing formulation and analytical development activities.
Oversee activities related to drug product/clinical supply at external vendors/CMO’s, including oversight of scale up, process optimization & prototyping.
Reviews all drug product related technical documents, including process research & development reports, master batch record documentation, campaign reports, and validation protocols & reports.
Takes an active role and applies subject matter expertise in establishing phase-appropriate process development and manufacturing strategies,
Implements Quality by Design (QbD) and applies risk-based principles to drug product development programs, including technical & quality risk assessments, Design of Experiments, and identification of critical quality attributes, critical process parameters, and manufacturing control strategies.
Supports production deviation & event investigations.
Provide technical support for IND and BLA filings.
Assists in the responses to health authority questions.
Leads process optimization efforts for improving functional processes and technical operations within CMC.
Participates in technical audits during vendor selection.
Qualifications and Experience
BS/MS with at least fifteen (15) years of experience or a Ph.D. with at least ten (10) years of experience in a bio-pharmaceutical area with appropriate therapeutic product development experience.
Experience in the development of lipid based drugs is a plus.
Successful leadership of drug product development.
Excellent awareness & understanding of other stakeholder roles and drug product development's relationship to them.
Excellent working knowledge of CGMP, regulatory guidance, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF and EP.
Demonstrable experience as a primary author of CMC sections in regulatory filings, such as IND, IMPD, and NDA.
Excellent technical writing, oral, presentation, and interpersonal communication skills.
Excellent data presentation & analysis skills, including the creation of publication quality tables & graphs.
Fluent in the Microsoft ecosystem, including Office & SharePoint, and PDF publication & editing software such as Adobe Acrobat. Comfortable with electronic records & digital workflows.
Detail-oriented and organized.
Possesses high integrity and exceptional work ethic.
Must be flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. Exceptional problem-solving skills.
Team oriented; ability to work collaboratively with internal colleagues and vendors.
Understands and anticipates the impact of business and commercial needs on advanced-stage drug development.
Some travel required, including both domestic and international (10%).
BACK TO CAREERS
Recent MTNB News
- Matinas BioPharma to Webcast Conference Call to Discuss First Quarter 2024 Financial Results and Provide a Business Update on May 9, 2024 • GlobeNewswire Inc. • 05/02/2024 11:00:00 AM
- In Vivo Efficacy of Matinas BioPharma’s Oral MAT2203 in Pulmonary Mucormycosis Published in Journal of Antimicrobial Agents and Chemotherapy • GlobeNewswire Inc. • 04/30/2024 12:00:00 PM
- Matinas BioPharma Prices $10 Million Registered Direct Offering • GlobeNewswire Inc. • 04/03/2024 12:30:00 PM
- Matinas BioPharma Reports 2023 Financial Results and Provides a Business Update • GlobeNewswire Inc. • 03/27/2024 08:05:00 PM
- Matinas BioPharma Announces Positive in vivo Safety Data with its Oral LNC-Docetaxel Formulation • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response • GlobeNewswire Inc. • 03/22/2024 01:15:00 PM
- Matinas BioPharma Regains Compliance with NYSE American Continued Listing Standards • GlobeNewswire Inc. • 03/22/2024 10:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/26/2024 01:05:14 PM
- Matinas BioPharma Provides Positive Outcomes Update on the MAT2203 Compassionate/Expanded Use Access Program, Including Multiple Patients with Complete Clinical Resolution • GlobeNewswire Inc. • 02/26/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 12:35:32 PM
- Matinas BioPharma Successfully Reaches Agreement with FDA for a Single Phase 3 Registration Trial to Support an NDA for MAT2203 for the Treatment of Invasive Aspergillosis • GlobeNewswire Inc. • 02/20/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/09/2024 12:30:25 PM
- Matinas BioPharma to Present at Biotech Showcase 2024 • GlobeNewswire Inc. • 01/03/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 12:40:40 PM
- Matinas BioPharma Demonstrates in vivo Biological Activity and Disease Improvement in Two Inflammatory Disease Models with Oral LNC-Delivered Small Oligonucleotides • GlobeNewswire Inc. • 12/27/2023 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/21/2023 12:40:46 PM
- Matinas BioPharma Provides Update to MAT2203 Regulatory and Development Pathway Following Feedback from FDA • GlobeNewswire Inc. • 12/21/2023 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/16/2023 02:46:31 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/16/2023 02:46:29 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM