HEAD, PHARMACEUTICAL MANUFACTURING SCIENCE & TECHNOLOGY 

 

Melinta 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: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate), VABOMERE® (meropenem and vaborbactam), and cefepime-taniborbactam. With an unsurpassed commitment to providers and patients, Melinta is dedicated to saving lives threatened by the global public health crisis of infections. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.

 

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 Summary

The Head, Manufacturing Science & Technology (MS&T) is key member of the Melinta team reporting to the Chief Technology Officer. The Head, 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 activitiesHelps with quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observations, and all processing issuesMaintain knowledge of regulatory environment, specifically including requirements for drug substance sections of clinical and registration submissionsAbility to guide dose presentation strategy development and responsible for understanding and applying data generated from experiments used to modify/optimize formulations

 

Qualifications

Minimum 15 years of experience in an FDA regulated environmentMinimum 10 years of experience in Manufacturing, Science, and Technology within the Pharmaceutical industryProven technical expertise with solids and injectables; development of multiple dosage forms including immediate and controlled release products and pediatric dosage formsDevelopment and tech transfer experience to internal and CDMO sitesMust have hands on experience with drug manufacturing scale up, technical transfer, product process optimization and improvementsGlobal CMC Regulatory experience with filing INDs/IMPDs/NDAs/MAAs, responding to Health Authority queries, and product approval/launchPost-approval life cycle management experience is a mustThorough understanding of commercialization processDemonstrated leadership and teamwork skillsExcellent 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 partnersExcellent 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.

 

Position Type

Full Time

 

Position Location and Travel

Preference for up to 3 in office days per week in Parsippany, NJ location

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.