Senior Manager, Process Development

Harmony Biosciences is recruiting for a Senior Manager, Process Development in our Plymouth Meeting, PA location. In this role you will support the operations of the Technical Ops organization for Harmony. These duties include operational oversight of multiple drug product contractors as well as coordinating the manufacturing of active and placebo tablets in support of Harmony's Clinical programs. This role will coordinate and execute all clinical packaging and distribution to various clinical depots and/or direct to patient shipments. This position will also support commercial manufacturing, drug product technical transfers and drug product development activities as required.

Responsibilities include but are not limited to:

• Manage operational and technical oversight of multiple Contract Organizations (COs) that comprise Harmony's global supply chain assuring the continued supply of clinical and commercial drug product inventories in a timely manner and avoiding stockouts.
• Manage the production and packaging of clinical drug and placebo product in support of multiple clinical studies.
• Manage clinical drug and placebo inventories at all clinical CO's.
• Work with Supply Chain to coordinate the manufacturing of clinical drug and placebo product in support of various clinical trial timelines.
• Ensure COs meet Harmony business objectives and all quality and compliance standards.
• Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility.
• Provide project management and technical support in transferring complex manufacturing processes from R&D to Commercial Manufacturing as well as between commercial sites.
• Provide technical support as needed specific to drug product manufacturing, packaging and testing.
• Identifies opportunities for continual improvement with a proven track record as a proficient solver of complex problems
• Provide technical support in the manufacturing, packaging and testing of drug substances and drug products at pilot and commercial scales.

Qualifications:

• Bachelor's Degree in Chemistry, Engineering or related field required, Master's Degree or higher preferred
• 5+ years of relevant experience in pharmaceutical development and manufacturing, process characterization, technical transfer, and process validation; Preferred to have experience with CMO management and oversight

• Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
• Technical proficiency and creativity, collaboration with others and independent thought in suggesting new methods, processes, etc.; Demonstrable knowledge of pharmaceutical analytical instrumentation and methodology is preferred
• 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 (office) 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 seven consecutive years based on our positive, values-based company culture

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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

Harmony Biosciences 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.

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.