Harmony Biosciences · 16 hours ago
Director, CMC Lead
Plymouth Meeting, PA
Full-time
Onsite
Director/Executive
8+ years expHarmony Biosciences is a pharmaceutical company focused on providing treatment options for rare neurological disorders. They are seeking a Director, CMC Lead to lead interdisciplinary teams in developing and executing product-specific integrated CMC strategies across various stages of the product lifecycle.
BiopharmaBiotechnologyHealth Care
Responsibilities
Lead cross-functional CMC teams for late-stage (Ph3 and launch) programs, while supporting programs in earlier (pre-clinical through Ph2) stages of development as necessary
Incorporate forward-thinking development plans, ensuring all necessary CMC activities will support registrational studies and commercial launch
Serve as the CMC “asset owner” with accountability to drive the creation and execution of Integrated 5-year CMC strategies and maintenance of 18-month rolling tactical project plans
Represent CMC on Franchise / Program Teams and actively collaborate with other functions (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company
Engage directly and extensively with operational and technical details across CMC functions, challenge technical SMEs, and lead effective problem-solving
Collaborate with Project Management, Quality, and Technical SMEs to manage key strategic vendor interactions for timelines, deliverables, and key milestones
Communicate and partner effectively with all functional areas within CMC (Technical Operations, Quality, Regulatory CMC), and other stakeholders (Pre-clinical Toxicology, Clinical Operations, Medical Affairs, etc.) to define and execute CMC strategies aligned with Franchise / Program Team Project Plans
Partner with CMC Project Managers to identify and escalate key issues and risks as well as resource allocation needs, as appropriate
Critically review relevant documents, including but not limited to all CMC regulatory submissions, briefing books, agency information requests, etc
Lead or contribute to continuous improvement initiatives across the organization
Partner with the business development group to support or lead due diligence evaluations and activities associated with bringing in new assets in partnership with alliance management, as necessary
Qualification
Required
Bachelor's degree required within scientifically relevant field (Chemical Engineering, Chemistry, etc.)
8+ years experience of relevant pharmaceutical industry experience with a focus on CMC development and matrix management required
Track record of effective matrix leadership experience in the setting of program teams across the full product life cycle, e.g., CMC, Tech Ops line functions, Quality, Regulatory CMC, sub-teams or other cross-functional teams operating in a matrix environment ideally across an organization required
Broad understanding of CMC, supply chain, DS and DP development, or LCM development extending from IND to NDA and global launch & lifecycle including a solid understanding of global registration processes required
Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others
Excellent communication, negotiation, problem solving and decision-making abilities
Demonstrated ability to identify critical program risks and develop mitigation plans – strategic or tactical to mitigate risk, costs, and reputation of Harmony's business
Proficient in the use of Microsoft Office Suite required
Preferred
Advanced degree MS / PhD / MBA is strongly preferred
Technical expertise in a relevant pharmaceutical development discipline; experience with small molecules preferred
Benefits
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 eight consecutive years based on our positive, values-based company culture
Company
Harmony Biosciences
Harmony Biosciences is a pharmaceutical company that develops and commercializes novel therapies for rare neurological disorders.
Founded in 2017Plymouth Meeting, Pennsylvania, USA
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.68BKey Investors
Blackstone Life SciencesBlackstone GroupOrbiMed
2024-10-30Post Ipo Secondary· $248M
2023-07-27Post Ipo Debt· $185M
2021-11-01Post Ipo Equity· $200M
Leadership Team
Jeffrey M. Dayno
President & Chief Executive Officer
Jeffrey Dierks
EVP & Chief Commercial Officer
Recent News
2026-01-13
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-13
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