Senior Vice President, CMC and Technical Operations

Harmony Biosciences is recruiting for a Senior Vice President, CMC and Technical Operations in our Plymouth Meeting, PA location. In this role you will provide leadership and strategic direction for all of Harmony Biosciences global manufacturing operations and supply chain activities to achieve corporate objectives and milestones. The scope of activities includes oversight of formulation development work for early-stage investigational products, timely delivery of clinical trial material for multiple late-stage development programs as part of Harmony's robust pipeline, and supply chain management of commercial products to ensure uninterrupted supply of quality products to serve the market. Additional responsibilities include careful oversight of the multiple contract manufacturing facilities that make up the network of suppliers in Harmony's global manufacturing operations and providing the CMC due diligence of potential new product opportunities identified by Harmony's Business Development team.

Responsibilities include but are not limited to:

• Lead the CMC and Technical Operations teams and provide strategic guidance to optimize global manufacturing operations.
• Design and implement business/operations strategies, plans and procedures to ensure availability of commercial products and clinical trial material supply.
• Lead the establishment and implementation of the complete road map to IND strategy to move compounds from discovery, through the pre-IND phase and into development through the different clinical phases, relative to the clinical program plan.
• Apply strong technical scientific skills and expertise to ensure design/creation of robust processes and formulations in a stage appropriate manner for drug product.
• Lead development of the formulation and packaging strategy for molecules in the pre-IND, post IND/Phase 1. Responsible for overseeing all clinical manufacturing of GMP batches for clinical, as well as scaling and optimizing all drug product activities through clinical development, registrational studies and NDA, and eventual transition to commercial supply.
• Ensure that stage-appropriate pre-formulation activities and characterization are performed on new molecules through the life cycle. Partner with discovery to perform solid state. characterization and support early animal vehicle formulation experiments in the pre-clinical phase. Work collaboratively to lead problem solving for compounds with poor solubility and/or poor stability during early development by partnering with both discovery and non-clinical.
• As the senior technical leader for the pre-formulation and drug product function, lead the team in integrating Drug Substance and other internal and external team members' activities into the pharmaceutical development plan.
• Develop and implement strategy for identification, selection and management of Contract Development Manufacturing Organizations (CDMOs) for process/formulation development, cGMP manufacture and supply of Clinical trial materials (CTMs) for clinical development programs.
• Work closely with the QA team to ensure comprehensive third-party vendor oversight for delivery of cGMP products is of the highest quality standards and in compliance with regulatory requirements.
• Manage internal experts within the organization to provide scientific and technical guidance to the CMOs while incorporating quality by design to ensure scalable and robust product and process development.
• Provide strategic and tactical input on preparation of CMC parts of the regulatory IND and NDA submissions.
• Support product development and pipeline progression by providing resources, facilities and technical support as needed.
• Negotiate favorable supply and technical/quality agreements with key vendors and partners and manage ongoing business relationships.
• Provide support for animal formulations development as needed and design appropriate formulations relative to the BCS classification of the compound taking into account any solubility limited challenges.
• Participate in due diligence activities (acquisitions, partnerships and strategic alliances, etc.). Lead the team in the development of annual department budgets and be accountable for operating to budget.
• Set comprehensive goals for performance and growth. Evaluate operational performance by analyzing and interpreting data and metrics.
• Develop and maintain annual operating budgets.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• This position has direct and indirect line management / supervisory responsibilities of Harmony CMC and Technical Operations teams.

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

• B.S. / M.S. in Engineering, Pharmacy, Chemistry or related scientific discipline; PhD desirable.
• 20+ years of experience in manufacturing and development operations or related areas in the pharmaceutical industry; 5+ years in a leadership role.
• Demonstrated technical proficiency and creativity, collaboration with others and independent thought in suggesting new methods, processes, etc.
• 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.

• High ethical & quality standards and demonstrates them through actions and communication
• Functions independently with minimal guidance while simultaneously covering multi-varied project responsibilities.
• Identifies opportunities for continual improvement with a proven track record as a proficient solver of complex problems.
• Demonstrated critical thinking and creativity to determine appropriate resources for resolution of problems and must have strong organizational and planning skills.

• Team orientated and ability to work collaboratively towards common objectives in a matrix organization.
• Decisive and demonstrated ability to make tough decisions, articulate the rationale for making the decision, and be able to defend one's position with poise and professionalism.
• Excellent verbal and written communication skills with experience interacting with multiple senior level internal and external stakeholders.
• Computer skills required: Microsoft Office Suite; Project Management Software.

Physical demands and work environment:

• Approximately 20-40% domestic and international travel; Candidate must hold or be able to obtain a US Passport.
• Occasionally work around fumes, airborne particles, or toxic chemicals.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• The employee must occasionally lift and /or move more than 50 pounds.
• 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 six 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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