Head, Pharmaceutical Manufacturing Science

3 hours ago

Parsippany, New Jersey, United States Melinta Therapeutics Full time
Job Summary

Melinta Therapeutics is seeking a highly experienced and dynamic professional to lead our Manufacturing Science & Technology team as the Head, Pharmaceutical Manufacturing Science & Technology. This key member of our team will report to the Chief Technology Officer and be responsible for providing strategic direction and technical leadership for development, characterization, and commercialization of drug substance and drug product, as well as manufacturing of drug substance and drug product.

Key Responsibilities
  • Provide strategic direction and technical leadership for development, characterization, and commercialization of drug substance and drug product, as well as manufacturing of drug substance and drug product.
  • Collaborate closely with Regulatory, Quality, Clinical, and Supply Chain to guide strategy of products through the lifecycle.
  • Perform due diligence as needed on potential acquisitions for fit and synergies within the current portfolio.
  • Responsible for the design and management of studies, protocol development, data evaluation, preparation, review, and completion of study reports to support drug product and formulation section.
  • Provide strategic oversight for drug substance and drug product manufacturing as well as analytical science.
  • Write and/or review protocols, final development reports, batch records, standard operating procedures, and other technical reports to support regulatory filings.
  • Manage complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Lead the development/optimization of scale-up efforts to support drug manufacturing.
  • Work effectively in a cross-functional matrix environment, with internal and external collaborators and proactively communicate with internal and external stakeholders.
  • Collaborate with internal resources, partners, consultants, and vendors for all technical operations related activities.
  • Helps with quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observations, and all processing issues.
  • Maintain knowledge of regulatory environment, specifically including requirements for drug substance sections of clinical and registration submissions.
  • Ability to guide dose presentation strategy development and responsible for understanding and applying data generated from experiments used to modify/optimize formulations.
Requirements
  • Minimum 15 years of experience in an FDA regulated environment.
  • Minimum 10 years of experience in Manufacturing, Science, and Technology within the Pharmaceutical industry.
  • Proven technical expertise with solids and injectables; development of multiple dosage forms including immediate and controlled release products and pediatric dosage forms.
  • Development and tech transfer experience to internal and CDMO sites.
  • Must have hands-on experience with drug manufacturing scale up, technical transfer, product process optimization, and improvements.
  • Global CMC Regulatory experience with filing INDs/IMPDs/NDAs/MAAs, responding to Health Authority queries, and product approval/launch.
  • Post-approval life cycle management experience is a must.
  • Thorough understanding of commercialization process.
  • Demonstrated leadership and teamwork skills.
  • Excellent analytical and communication abilities.
  • Good understanding of process validation concepts and experience with technical transfer preferred.
  • Must have strong interpersonal skills, strong customer focus given the need to integrate activities with CMOs, cross-functional, and collaborative partners.
  • Excellent presentation skills and the ability to concisely describe complicated issues to leadership team.
  • Other areas of experience would be a plus; Drug Product formulations (Phase I, II, Phase III programs), QbD, Analytical lab/methods, Quality, CMO (contract manufacturing organization), clinical supplies.
Education

MS or PhD in Pharmaceutical Sciences, Physical Sciences, Engineering, or related Life Sciences is required. PhD preferred.

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