Reference #: 1361 Harmony Biosciences is recruiting for a Manager, Manufacturing & Packaging in our Plymouth Meeting, PA location. In this role you will support the Technical Operations organization for Harmony Biosciences. These duties will include primarily supporting operational oversight of multiple drug product manufacturing and packaging contractors, producing supplies for commercial finished products. This position will orchestrate and execute activities for Harmony to support uninterrupted supply of pharmaceutical drug products of the highest quality for our patients. Responsibilities include but are not limited to: Support operational oversight of multiple Contract Organizations (COs) that comprise Harmony's global supply chain, with the following responsibilities: Coordinate and support the successful production and packaging of commercial drug product in a timely manner to maintain commercial inventories and avoidance of stockouts. Support development of production plan and drive execution to achieve target inventories throughout each link of the supply chain. Manage manufacturing and packaging deviations and related investigations to successful closure in a timely manner and in close collaboration with Harmony's Quality function. Oversee and co-manage stability programs for intermediates, drug substance and drug product with Quality Assurance Maintenance of lifecycle product documentation to support annual product reviews and annual reporting procedures. Development and maintenance of materials and manufacturing and manufacturing related financial cost models. Collaborate with internal teams to support development of supply chain roadmaps, operational production plans, budgets to support cash flow management, maintaining contract compliance, and articulating management of supply chain risk. Support/develop procedures and consistent ways of working within the scope of work of the Technical Operations team. Support supply chain activities for late-stage development products, on an as needed basis. Ensure COs meet Harmony business objectives while meeting quality and compliance standards. Drive for uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility. Collaborate with other Harmony departments as required to: Achieve corporate goals and mission for uninterrupted commercial supply to patients. Develop and maintain commercial supply and technical aspects of quality agreements. Implement process improvement or other product lifecycle programs. Participate and support the execution of technology transfers. Support the launch and technical stewardship of commercial products. Prepare and review dossiers for regulatory filings. Drive fiscal responsibility with the operational budget. Qualifications: Bachelor's degree in a scientifically related field required 3+ years of pharmaceutical manufacturing experience Technical proficiency in the manufacturing, packaging and analytical testing of drug products. Experience transferring analytical methods from R&D to Commercial Manufacturing is preferred with a demonstrable knowledge of pharmaceutical analytical instrumentation and methodology. Experience with managing CMO's is preferred. Experience with pharmaceutical packaging and knowledge of DSCSA requirements is preferred. Knowledge and application of Pharmaceutical Manufacturing and Packaging principles, concepts, industry practices, and standards to troubleshoot technical problems. Knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated Quality Guidance's and principles. Proficient in the use of Microsoft Office Suite Excellent verbal, written and interpersonal communication skills, with the ability to communicate with colleagues, business partners, stakeholders and upper management and influence and coach positive behaviors across multiple contractors. Physical demands and work nvironment: Domestic travel is estimated to be 25% of the time for this position. While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (office) to moderate (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 date Generous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings Plan Paid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunities A certified Great Place to Work for six consecutive years based on our positive, values-based company culture

Want to see our latest job opportunities? Follow us on LinkedIn! 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 www.harmonybiosciences.com

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.