Associate Director, Formulation Development

Harmony Biosciences is recruiting for an Associate Director, Formulation Development in our Plymouth Meeting, PA location. In this role you will supports the Pharmaceutical Development Sciences organization of 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/partnersDirect 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)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 and oral solution/suspensionDesign experiments to evaluate the impact of raw materials, container closure, process parameters to identify the critical formulation/process parameters and control strategiesServe as technical expert on drug product aspects with particular emphasis on safety, strength, purity, quality, and product performance and associated methodologiesEnsure that CDMOs activities and process development activities address drug product needs for pre-clinical testing, stability, and clinical trialsOversee and co-manage release testing and stability programs for drug product with Quality AssuranceDrive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibilityCompile, 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.

Qualifications:

Bachelors degree required in Pharmaceutical Sciences, Chemical Engineering, or related field, Masters, or PhD preferred7+ years of relevant experience in pharmaceutical development and manufacturing required Understanding of ICH, FDA, and USP guidelines and applying these guidelines in context of the stage of drug development required Experience working with or managing Contract Development and Manufacturing Organizations (CDMOs), including remote and on-site oversight required 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 required In-depth knowledge and application of Pharmaceutical Development and Manufacturing principles, concepts, industry practices, and standards to benefit Harmonys interestsIn-depth knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated Quality Guidances and principlesExcellent verbal, written and interpersonal communication skills, with the ability to communicate with colleagues, business partners and stakeholders, and influence positive behaviors across multiple contractorsProficient in the use of Microsoft Office productsPhysical demands and work environment:

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.

What can Harmony offer you?

Medical, Vision and Dental benefits the first of the month following start dateGenerous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings PlanPaid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunitiesA certified Great Place to Work for eight consecutive years based on our positive, values-based company culture Want to see our latest job opportunities? Follow us on LinkedIn! 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.comHarmony 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. #LI-Remote