Director, CMC Lead

Overview

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.

• 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

• Bachelor's degree required within scientifically relevant field (Chemical Engineering, Chemistry, etc.);
  Advanced degree MS / PhD / MBA is strongly preferred
• 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

• Travel (both domestic and international) is estimated to be 20% of the time for this position;
  Candidate must be able to maintain or obtain valid US Passport within 90 days of hire date. While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (office) to moderate (laboratory/manufacturing). Hearing protection will be required at times.
• 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.

• 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…