Associate Director, Formulation Development

Harmony Biosciences Llc • Plymouth Meeting, PA

15h • Remote

About The Position

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/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 Harmony’s 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/suspension 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.

Requirements

• Bachelor’s degree required in Pharmaceutical Sciences, Chemical Engineering, or related field, Master’s, or PhD preferred
• 7+ 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 Harmony’s interests
• In-depth knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated Quality Guidance’s and principles
• Excellent verbal, written and interpersonal communication skills, with the ability to communicate with colleagues, business partners and stakeholders, and influence positive behaviors across multiple contractors
• Proficient in the use of Microsoft Office products
• 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.
• 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.

Nice To Haves

• Master’s, or PhD preferred

Responsibilities

• 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 Harmony’s 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/suspension
• 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.

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
• Number of Employees: 101-250 employees