Reference #: 1375 Harmony Biosciences is recruiting for an Associate Director, Process Development in our Plymouth Meeting, PA location. In this role you will be part of the Technical Operations organization at Harmony Biosciences and will be responsible for operational and technical oversight of multiple drug product contractors. This position will coordinate and execute Clinical Supply and Development activities for Harmony to result in uninterrupted supply of pharmaceutical drug products of the highest quality for our patients. Responsibilities include but are not limited to: Direct operational and technical oversight of multiple Contract Organizations (COs) that comprise Harmony's global supply chain, with the following responsibilities: Support the successful production of clinical drug product in a timely manner to maintain inventories and avoidance of stockouts Provide technical support for the execution of the development and clinical production plan Execute successful product scale up, technology transfer, and process change activities Demonstrate technical proficiency in the manufacturing, packaging and testing of drug substances and drug products at pilot and commercial scales Manage process and lab deviations to successful closure in a timely manner as product SME in close and seamless collaboration with Harmony's Quality function Work closely with analytical and manufacturing development teams 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; Maintain lifecycle product documentation and trend data files to support annual product reviews and annual reporting procedures; Transfer complex manufacturing processes from R&D to Commercial Manufacturing as evidenced by successful PPQ and CPV experiences Collaborate with other Harmony departments as required to: Achieve corporate goals and mission for uninterrupted supply to patients; Develop and maintain supply and technical aspects of quality agreements; Implement process improvement or other product lifecycle programs; Support the launch and technical stewardship of commercial products; Prepare and review dossiers for regulatory filings Drive fiscal responsibility with the operational budget and cost savings initiatives; Qualifications: Bachelor's Degree within a scientific discipline required, Master's degree preferred 8+ years of relevant technical experience in pharmaceutical development and manufacturing, process characterization, technical transfer, and process validation Preferred to have experience with CMO management and oversight Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development Proven track record of transferring complex manufacturing processes from R&D to Commercial Manufacturing as evidenced by successful PPQ and CPV experiences In-depth knowledge and application of Pharmaceutical Development and Manufacturing principles, concepts, industry practices, and standards to benefit Harmony's interests In-depth knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated Quality Guidance's and principles Experienced with state-of-the-art technical and compliance guidance to drive the manufacturing and testing of drug substances and drug products of the highest quality Working knowledge of supply chain planning, management and operations Proficient in the use of Microsoft Office Suite, with a focus on MS Project, and Excel, other internal systems Physical demands and work environment: Global and domestic travel 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 (off ce) to moderate (manufacturing).  Hearing protection will be required at times. The employee must occasionally lift and /or move more than 20 pounds. 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.