Melinta Therapeutics LLC
Senior Director, Manufacturing Science & Technology
Melinta Therapeutics LLC, Chicago, Illinois, United States,
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.Senior Director, Manufacturing Science & Technology
Full-time Regular Lincolnshire, IL, US15 days ago Requisition ID: 1304Senior Director, Pharmaceutical Manufacturing Science & TechnologyIf you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then Melinta Therapeutics might be the right place for you. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge, and flexibility are valued.Melinta provides innovative therapies for acute and life-threatening illnesses, with commercial and medical capabilities, specializing in infectious diseases and acute care. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.Position SummaryThe Senior Director, Manufacturing Science & Technology (MS&T) is a key member of the Melinta team reporting to the Vice President of Quality and Technical Ops. The Senior Director, MS&T is an experienced and dynamic professional with capabilities to 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. 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.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.QualificationsMinimum 10 years of experience in an FDA regulated environment.Minimum 7 years of experience in Manufacturing, Science, and Technology within the Pharmaceutical industry.Demonstrated project management skills.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.Must have hands-on experience with drug manufacturing scale-up, technical transfer, product process optimization, and improvements.Thorough understanding of commercialization process.Other areas of experience would be a plus; Drug Product formulations (Phase I, II, Phase III programs), QbD, Analytical lab/methods, Quality, Regulatory, FDA meetings, CMO (contract manufacturing organization), clinical supplies.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 Lincolnshire, IL or Parsippany, NJ locations.Ability to travel up to 25%.Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.
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Full-time Regular Lincolnshire, IL, US15 days ago Requisition ID: 1304Senior Director, Pharmaceutical Manufacturing Science & TechnologyIf you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then Melinta Therapeutics might be the right place for you. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge, and flexibility are valued.Melinta provides innovative therapies for acute and life-threatening illnesses, with commercial and medical capabilities, specializing in infectious diseases and acute care. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.Position SummaryThe Senior Director, Manufacturing Science & Technology (MS&T) is a key member of the Melinta team reporting to the Vice President of Quality and Technical Ops. The Senior Director, MS&T is an experienced and dynamic professional with capabilities to 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. 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.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.QualificationsMinimum 10 years of experience in an FDA regulated environment.Minimum 7 years of experience in Manufacturing, Science, and Technology within the Pharmaceutical industry.Demonstrated project management skills.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.Must have hands-on experience with drug manufacturing scale-up, technical transfer, product process optimization, and improvements.Thorough understanding of commercialization process.Other areas of experience would be a plus; Drug Product formulations (Phase I, II, Phase III programs), QbD, Analytical lab/methods, Quality, Regulatory, FDA meetings, CMO (contract manufacturing organization), clinical supplies.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 Lincolnshire, IL or Parsippany, NJ locations.Ability to travel up to 25%.Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.
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