Reference #: 1320Harmony Biosciences is recruiting for an Director, Manufacturing Development (Drug Substance)in our Plymouth Meeting, PA location. In this role you will support the operations of the Manufacturing Development Operations organization for Harmony. These duties will include directing the development of small molecules, drug substance outsourced programs, enabling cGMP manufacturing for commercial or clinical use. This position will lead, manage the development of chemical process for active pharmaceutical ingredients (APIs), process scale-up, technology transfer, and validation activities that are outsourced (domestic and international contract organizations) by Harmony to support uninterrupted supply of pharmaceutical drug substance of the highest quality for our patients.Responsibilities include but are not limited to:Devise detailed plans for API process development/optimization, scale-up, and validation in a phase-appropriate manner and execute them via contract service providers/partnersLead and support API development activities to ensure that the chemical processes are robust and compliant with regulatory guidelines for Harmony's early and late-stage programsDirect technical oversight of multiple Contract Organizations (COs), with the following responsibilities:Evaluation and selection of CDMO(s) to effectively develop and manufacture required starting materials, intermediates, and drug substancesServe as technical expert on drug substance with particular emphasis in process chemistry and associated methodologiesProvide oversight and serve as technical lead for chemical steps, manufacturing process, criticality of API processing parameters, establishing specifications, and quality controlEnsure that COs activities and process development activities address drug substance needs for formulation development, pre-clinical testing, clinical trials and commercial launchA working knowledge of manufacturers and suppliers of chemical raw materials, intermediates, and reagents that meet quality and compliance standards to support drug substance developmentOversee and co-manage release testing and stability programs for drug substance with Quality AssuranceDrive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibilityExtract and review data files related to drug substance activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, certificates, Drug Master Files (DMF's) etc.Collaborate with other Harmony departments as required to:Achieve corporate goals and mission for uninterrupted clinical and commercial supply to patientsWork with Legal team in the evaluation of patent criteriaWork with Clinical/Medical teams to integrate preclinical and clinical DS needs and timelines into developmentWork closely with teams to define process development strategyDevelop and maintain technical aspects of quality agreementsLead the execution of drug substance technology transfers, qualification/validationWork closely with Regulatory CMC to write / review drug substance sections for regulatory filingsQualifications:Bachelor of Science or medicinal chemistry and/or organic chemistry required with a minimum of 13+ years of experience; Master's Degree or PhD preferred in organic chemistry with 10+ years of experience13+ years' experience managing API process development, process validation, and manufacturing in support of NDA marketing applications and commercial production5+ years' experience within project leadershipDemonstrated track record of delivering candidate(s) into chemical development, manufacturing, and commercializationDemonstrated chemical process development at laboratory and industrial scale process validationStrong aptitude and demonstrated experience in synthetic organic chemistryWorking knowledge of modern analytical techniques on the s paration/purification/analysis of organic compoundsFamiliarity with FDA/EU and ICH guidelines for INDs/NDAs/MAAs /cGMPs and QSAR Quantitative structure active relationshipExperience in managing CMOs, scientific collaborations, and contracted R&D is a plus.Proficient in the use of Microsoft Office productsPhysical demands and work environment:Travel (both domestic and international) is estimated to be 30% of the time for this position.Must be able to maintain / obtain a valid US Passport.While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (office) to moderate (laboratory/manufacturing). Hearing protection will be required at times.Specific vision abilities required by this job include: close vision.Manual dexterity required to use computers, tablets, and cell phone.Continuous sitting for prolonged periods.What can Harmony offer you?Medical, Vision and Dental benefits the first of the month following start dateGenerous paid time off and Company designated HolidaysCompany paid Disability benefits and Life Insurance coverage401(k) Retirement Savings PlanPaid Parental leaveEmployee Stock Purchase Plan (ESPP)Company sponsored wellness programsProfessional development initiatives and continuous learning opportunitiesA certified Great Place to Work for five consecutive years based on our positive, values-based company culture

　　Want to see our latest job opportunities? Follow us on !Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit

　　Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

　　Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.