Director, CMC Lead

Harmony Biosciences LLC • Plymouth Meeting, PA

6d • Hybrid

About The Position

Harmony Biosciences is recruiting for a Director, CMC Lead in our Plymouth Meeting, PA location. In this role you will be accountable for – and provide leadership to – interdisciplinary, matrix teams responsible for developing and executing product-specific integrated CMC strategies.  The position is responsible for creating and formalizing the CMC strategy for multiple programs at various stages of lifecycle, to drive R&D / Commercial Franchise Team objectives and incorporate all CMC elements across drug substance, drug product, analytical, quality, regulatory CMC, and clinical/commercial supply. The CMC Lead will have a strong technical background and is expected to communicate and collaborate with the technical SMEs and lead the team in problem solving issues across the CMC functions.

Requirements

• 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
• Technical expertise in a relevant pharmaceutical development discipline; experience with small molecules preferred
• 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

Nice To Haves

• Advanced degree MS / PhD / MBA is strongly preferred

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level