Associate Director, Process Development

Harmony Biosciences is recruiting for a, Associate Director, Process Development in our Plymouth Meeting, PA location. In this role you will support the Process Development and Clinical Supply organization for Harmony. Responsibilities include technical and operational oversight of Harmony's late-stage development programs, direct oversight of multiple drug product CDMOs, as well as coordination of IMP manufacturing in support of Harmony's Clinical programs. This role is pivotal in ensuring successful technology transfer, scale-up, process validation, and regulatory submissions across a portfolio of pharmaceutical products, with a strong emphasis on solid oral dosage forms and familiarity with multiple dosage forms.

Responsibilities include but are not limited to:

• Ensure seamless transfer of knowledge and responsibilities from Manufacturing Development technical leads as programs progress to later stages of development
• Lead tech transfer, scale-up and validation activities from development to clinical and commercial manufacturing for multiple dosage forms (e.g., tablets, solutions, semi-solids).
• 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.
• Lead the design, execution, and analysis of process validation studies and clinical supply campaigns.
• Manage the production and packaging of clinical drug and placebo product in support of multiple clinical studies.
• Collaborate cross-functionally with Manufacturing Development, Regulatory Affairs, Quality, Supply Chain, and Clinical teams to ensure robust end-to-end process support.
• Work with Supply Chain and Clinical Supply to coordinate the manufacturing of clinical drug product in support of various clinical trial timelines.
• Serve as Process Development lead on cross-functional teams, providing subject matter expertise (SME) for manufacturing processes and troubleshooting technical issues.
• Ensure COs meet Harmony business objectives and all quality and compliance standards.
• Author and review CMC regulatory submissions (INDs, NDAs, IMPDs, etc.), including process descriptions, validation strategies, and control strategies
• Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility.
• Provide technical support in transferring complex manufacturing processes from Manufacturing Development to Commercial Manufacturing as well as between commercial sites.
• Provide technical support as needed specific to drug product manufacturing, packaging and testing.
• Interpret process and quality data to support continuous improvement and enhance manufacturing robustness.
• Provide technical support in the manufacturing, packaging and testing of drug substances and drug products at pilot and commercial scales.
• Travel to CMOs and internal/external manufacturing sites to support on-site technical activities, audits, investigations, and process performance verification.

Qualifications:

• Bachelor's degree required in pharmaceutical Sciences, Chemical Engineering, or related field, Master's, or PhD preferred
• 8+ years of relevant experience in pharmaceutical development and manufacturing, process characterization, technical transfer, and process validation is required
• Highly experienced in solid oral dose manufacturing (granulation, blending, compression, coating), with exposure to other dosage forms (e.g., liquids, semi-solids, or injectables) considered is required
• Demonstrated success in technology transfer, clinical and commercial scale-up, and process validation.
• Experience working with or managing Contract Manufacturing Organizations (CMOs), including remote and on-site 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.
• 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 25% 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.

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