Head, Pharmaceutical Manufacturing Science& Technology
: Job Details :

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.Head, Pharmaceutical Manufacturing Science & TechnologyFull-time Regular, Parsippany, NJ, US7 days ago, Requisition ID: 1329HEAD, PHARMACEUTICAL MANUFACTURING SCIENCE & TECHNOLOGYMelinta Therapeutics is a biopharmaceutical company with strong commercial and medical capabilities dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. Melinta's current portfolio includes seven commercial stage products and one investigational product under review by FDA. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.Position SummaryThe Head, Manufacturing Science & Technology (MS&T) is a key member of the Melinta team reporting to the Chief Technology Officer. This position requires strategic direction and technical leadership for development, characterization, and commercialization of drug substance and drug product, as well as manufacturing. Experience in troubleshooting and understanding analytical issues and methods is also a plus.The successful candidate will have proven experience in leading internal CMC teams and managing external teams consisting of licensed partners, CROs, and CMOs. This leader will possess a deep understanding of formulation development to lead the efforts on new and existing products. This is a leadership position with management responsibility for a team of two.Strong leadership skills including people management and executive presence.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.Help 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.QualificationsMinimum 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.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.Strong interpersonal skills and 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.EducationMS or PhD in Pharmaceutical Sciences, Physical Sciences, Engineering or related Life Sciences is required. PhD preferred.Position TypeFull TimePosition Location and TravelPreference for up to 3 in office days per week in Parsippany, NJ location. Ability to travel up to 25%.#J-18808-Ljbffr