Director, Formulation Development, Drug Product

Harmony Biosciences Holding, Inc.

Reference #: 1360
Harmony Biosciences is recruiting for a Director, Formulation Development, Drug Product in our Plymouth Meeting, PA location. In this role you will support the Manufacturing Development Operations organization for Harmony Biosciences. These duties include direct oversight of multiple drug product development programs of diverse dosage forms for adult and pediatric indications. The position will serve as a scientific technical expert for CMC activities for early and late-stage programs leading to the manufacture of clinical trial material to support life cycle management and new programs.
Responsibilities include but are not limited to:
Define the quality target product profile and design project plans for pre-formulation, formulation, and process development/optimization, and scale-up, in a phase-appropriate manner and execute them via contract service providers/partners.
Direct and review drug product development activities to ensure that a quality product is produced, and its manufacturing process delivers the intended performance of the product and is compliant with regulatory guidelines for Harmonys early and late-stage programs.
Direct technical oversight of multiple Contract Organizations (COs), with the following responsibilities:
Participate in the evaluation and selection of CDMO(s) to effectively develop, test and manufacture drug products of diverse dosage forms such as, but not limited to: oral solid, oral solution/suspension and topical.
Design experiments to evaluate the impact of raw materials, container closure, process parameters to identify the critical formulation/process parameters and control strategies.
Serve as technical expert on drug product aspects with particular emphasis on safety, strength, purity, quality, and product performance and associated methodologies.
Ensure that CDMOs activities and process development activities address drug product needs for pre-clinical testing, stability, and clinical trials.
Oversee and co-manage release testing and stability programs for drug product with Quality Assurance.
Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility.
Compile, review, and archive data files related to drug product activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, engineering and cGMP records, stability, and supportive documentation, etc.
Collaborate with other Harmony departments as required to:
Achieve corporate goals and mission for uninterrupted clinical and commercial supply to patients.
Monitor and manage operational budget and scope of work of CDMOs.
Work closely with teams to define process development strategy.
Develop and maintain technical aspects of Quality Agreements.
Lead the execution of drug product technology transfers, support method implementation, qualification/validation.
Work closely with Regulatory CMC to write / review drug product sections for regulatory filings.
Qualifications:
Bachelors degree required within scientifically relevant field (Engineering, Chemistry, etc.), MS / PhD preferred.
10 years of relevant pharmaceutical industry experience
Familiarity with FDA/EU and ICH guidelines for INDs/NDAs/MAAs and cGMPs.
Experience in managing CDMOs, scientific collaborations, and contracted R&D is a plus.
Technical proficiency in the manufacturing, packaging and interpretation of analytical and formulation testing of drug products at pilot and commercial scales, with particular emphasis on physical chemical characterization techniques to include solution and solid state stability.
Experienced with state-of-the-art technical and compliance guidance to drive the manufacturing and data interpretation of drug products to ensure the highest quality.
Excellent verbal, written and interpersonal communication skills, with the ability to communicate to colleagues, business partners, stakeh lders and upper management and influence and coach positive behaviors across multiple contractors.
Proficient in the use of Microsoft Office products.
Physical demands and work environment:
Travel (both domestic and international) is estimated to be 20% 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 (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.
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

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/CVs submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Harmony Biosciences, LLC 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.

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