Director of Drug Product Development
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.
- 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%).
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