Director, Formulation Development, Drug Product

4 weeks ago

Plymouth Meeting, United States Harmony Biosciences LLC Full time

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 Harmony's 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:

  • Bachelor's 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, stakeholders 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

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.com

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.

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.

  • Director Of Sales

    15 hours ago

    Plymouth Meeting, United States Empirical Consulting Solutions Full time

    Job DescriptionJob DescriptionDirector of SalesCompany and Position OverviewRiley Sales is a very successful and proud 3rd generation family business seeking a trusted sales leader and marketing partner with an entrepreneurial spirit. Are you ready to help innovate growth by partnering with dynamic individuals who share a passion for success?The Director of...

  • Associate Director, Regulatory Affairs

    3 weeks ago

    Plymouth Meeting, United States Organon & Company Full time

    Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead development and execution of global product and project regulatory strategi Regulatory Affairs, Chemistry, Director, Controls, Manufacturing, Regulatory, Technology, Healthcare

  • Senior Director of Software Engineering, New Product Introduction

    1 week ago

    Plymouth, Massachusetts, United States Philips Full time

    Job Title Senior Director of Software Engineering, New Product Introduction Job Description As a key member of the Image Guided Therahy-Devices (IGT-D) R&D management team the Senior Director of Software Engineering, NPI leads a global R&D team and drives full product development lifecycle of clinical application and our SW platform architecture.Your...

  • Senior Director of Software Engineering, New Product Introduction

    1 month ago

    Plymouth, United States Philips Full time

    Job Title Senior Director of Software Engineering, New Product Introduction Job Description As a key member of the Image Guided Therahy-Devices (IGT-D) R&D management team the Senior Director of Software Engineering, NPI leads a global R&D team and drives full product development lifecycle of clinical application and our SW platform architecture. Your role:...

  • Senior Director of Software Engineering, New Product Introduction

    3 weeks ago

    Plymouth, United States Philips Full time

    Job Title Senior Director of Software Engineering, New Product Introduction Job Description As a key member of the Image Guided Therahy-Devices (IGT-D) R&D management team the Senior Director of Software Engineering, NPI leads a global R&D team and drives full product development lifecycle of clinical application and our SW platform architecture. Your role:...

  • Associate Director, Research

    1 month ago

    Plymouth Meeting, United States Harmony Biosciences LLC Full time

    Harmony Biosciences is recruiting for an Associate Director, Research & Development Portfolio Management in our Plymouth Meeting, PA location. In this role you will partner with project teams across the preclinical and clinical development portfolio, integrating drug development across all functions, and translating strategy into execution to deliver...

  • Associate Director, Research

    4 weeks ago

    Plymouth Meeting, United States Harmony Biosciences LLC Full time

    Harmony Biosciences is recruiting for an Associate Director, Research & Development Portfolio Management in our Plymouth Meeting, PA location. In this role you will partner with project teams across the preclinical and clinical development portfolio, integrating drug development across all functions, and translating strategy into execution to deliver...

  • Medical Director, Clinical Development

    1 week ago

    Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

    Harmony Biosciences is recruiting for a Medical Director, Clinical Development & Strategy in our Plymouth Meeting, PA location. In this role you will be responsible for leading and driving input into clinical development strategy for key programs and studies for Harmony Biosciences. This role will serve as the medical lead on Harmony's Epilepsy programs as...

  • External Quality Assurance, Formulation Associate

    2 weeks ago

    Plymouth Meeting, United States Organon Full time

    **The Position** The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved...

  • Business Technology Regulatory Product Owner

    1 week ago

    Plymouth Meeting, United States Organon & Co. Full time

    Job Description The Position The Business / Technical Analyst - Regulatory Technology Products will report directly to the Director of Regulatory Business Technology and will be a key member of the Organon Research and Development (R&D) Business Technology team. This position is responsible for the vision and prioritization (via translated business needs)...

  • Director of Communications

    2 weeks ago

    Plymouth Meeting, United States Eastern Pennsylvania Youth Soccer Full time

    Company DescriptionEastern Pennsylvania Youth Soccer is an organization dedicated to promoting, fostering, and perpetuating the game of soccer on the youth level in the Eastern Pennsylvania territory. Our mission is to foster the mental, physical, and emotional growth of the youth in Eastern Pennsylvania through the sport of soccer.Role DescriptionThis is a...

  • Director of Communications

    1 week ago

    Plymouth Meeting, United States Eastern Pennsylvania Youth Soccer Full time

    Company DescriptionEastern Pennsylvania Youth Soccer is an organization dedicated to promoting, fostering, and perpetuating the game of soccer on the youth level in the Eastern Pennsylvania territory. Our mission is to foster the mental, physical, and emotional growth of the youth in Eastern Pennsylvania through the sport of soccer.Role DescriptionThis is a...

  • Learning & Development Coordinator

    4 weeks ago

    Plymouth Meeting, United States Griswold Home Care Full time

    Job DescriptionJob DescriptionDo you want to join a fun, hard-working, ambitious team that helps support small businesses around the country? The Learning and Development Coordinator will play a key role in the development of learning material and programs, as well as providing support to the Senior Director of Learning & Development. The ideal candidate is...

  • Executive Director, Clinical Research

    2 weeks ago

    Plymouth Meeting, United States Organon Full time

    **The Position** The Executive Director, Asset Development Team (ADT) Leader will have accountability to lead cross-functional Asset Development Teams in the development of key late-stage pipeline assets. She/he will be responsible for the development of an aligned asset development strategy, driving the planning, execution, and delivery of cross-functional...

  • Business Technology Regulatory Product Owner

    1 week ago

    Plymouth Meeting, United States Organon Full time

    Job Description The Position The Business / Technical Analyst - Regulatory Technology Products will report directly to the Director of Regulatory Business Technology and will be a key member of the Organon Research and Development (R&D) Business Technology team. This position is responsible for the vision and prioritization (via translated business needs) of...

  • Creative Director

    3 days ago

    Plymouth Meeting, United States Vault Communications Full time

    We are seeking an experienced, visionary - and most importantly, hands-on - Creative Director. From pitch to launch, you know how to bring campaigns to life, assemble the right teams and deliver results for our clients. You will work alongside the Senior Vice President of Creative Strategy to lead the charge in crafting innovative campaigns that resonate and...

  • Creative Director

    3 weeks ago

    Plymouth Meeting, United States Vault Communications Full time

    Job Description Job Description Salary: We are seeking an experienced, visionary -- and most importantly, hands-on -- Creative Director. From pitch to launch, you know how to bring campaigns to life, assemble the right teams and deliver results for our clients. You will work alongside the Senior Vice President of Creative Strategy to lead the charge in...

  • Associate Director, Regulatory Affairs

    3 weeks ago

    Plymouth Meeting, United States Organon Full time

    Job Description The Position The Associate Principal Scientist is responsible fordeveloping andimplementing Regulatory Chemistry, Manufacturing and Controls (CMC) strategies forassignedsmall molecule products in accordance with global regulations andguidance's, andCompany procedures. The Associate Principal Scientist will lead thepreparation and submission...

  • Production Artist

    2 months ago

    Plymouth Meeting, United States L2 Brands Full time

    Job DescriptionJob DescriptionL2 Brands is a leading designer, manufacturer and marketer of high-quality, custom-logo apparel, headwear and home décor serving the large and growing Collegiate, Resort/Destination, Golf and Corporate markets. For over 30 years, L2 Brands, through its League, Legacy, Ouray and Locale lifestyle brands, has created premium...

  • Production Artist

    4 weeks ago

    Plymouth Meeting, United States L2 Brands Full time

    Job DescriptionJob DescriptionL2 Brands is a leading designer, manufacturer and marketer of high-quality, custom-logo apparel, headwear and home décor serving the large and growing Collegiate, Resort/Destination, Golf and Corporate markets. For over 30 years, L2 Brands, through its League, Legacy, Ouray and Locale lifestyle brands, has created premium...