13 Drug Formulation jobs in the United States
Principal Pharmaceutical Scientist - Drug Formulation
Posted 2 days ago
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Responsibilities:
- Lead the formulation development of complex drug candidates from pre-clinical through to commercialization stages.
- Design and execute pre-formulation studies, including solubility, stability, and compatibility assessments.
- Develop robust and scalable manufacturing processes for solid oral dosage forms (tablets, capsules).
- Evaluate and select appropriate excipients to achieve desired drug release profiles and bioavailability.
- Conduct hands-on laboratory work, including formulation preparation, analytical testing, and process optimization.
- Troubleshoot formulation challenges and identify root causes for development issues.
- Prepare detailed formulation development reports, protocols, and summaries for regulatory filings (e.g., IND, NDA).
- Collaborate with analytical development, process engineering, and manufacturing teams to ensure successful scale-up and technology transfer.
- Stay current with industry trends, new technologies, and regulatory guidelines related to drug formulation and delivery.
- Mentor and guide junior scientists, fostering their technical and professional growth.
- Contribute to intellectual property strategy by identifying patentable inventions.
- Manage multiple projects simultaneously, prioritizing tasks and ensuring timely project completion.
- Conduct literature reviews and competitive landscaping for formulation strategies.
- Provide technical expertise and support for formulation-related queries from manufacturing and quality assurance.
- Present scientific findings at internal meetings and external conferences.
Qualifications:
- Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, Chemical Engineering, or a related discipline.
- Minimum of 8-10 years of experience in pharmaceutical drug formulation development, with a strong focus on solid oral dosage forms.
- In-depth knowledge of pre-formulation techniques, excipient science, and drug delivery principles.
- Hands-on experience with various formulation development equipment and analytical techniques (e.g., HPLC, dissolution testing, DSC, TGA).
- Proven experience in developing formulations for challenging molecules (e.g., low solubility, low permeability).
- Strong understanding of cGMP requirements and regulatory guidelines (FDA, EMA).
- Excellent scientific judgment, problem-solving skills, and attention to detail.
- Demonstrated leadership capabilities and the ability to mentor junior staff.
- Strong written and verbal communication skills, with the ability to effectively present complex scientific information.
- Experience with bioavailability enhancement technologies and controlled release systems is highly desirable.
- Ability to manage multiple projects and priorities effectively in a fast-paced environment.
Senior Pharmaceutical Scientist - Drug Formulation
Posted 3 days ago
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Senior Formulation Scientist - Drug Development
Posted today
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Job Description
Responsibilities:
- Design and execute experiments for the formulation development of various dosage forms (e.g., oral solids, injectables, topical).
- Evaluate and select appropriate excipients and drug delivery technologies.
- Perform pre-formulation studies, including solubility, stability, and compatibility assessments.
- Develop and optimize manufacturing processes for drug products.
- Conduct analytical testing to characterize formulated products (e.g., HPLC, dissolution, particle size analysis).
- Prepare formulation development reports, protocols, and regulatory submission documents.
- Collaborate with cross-functional teams, including analytical development, process development, and clinical operations.
- Troubleshoot formulation challenges and identify solutions to optimize product performance.
- Stay current with scientific literature, industry trends, and regulatory guidelines in pharmaceutical formulation.
- Mentor junior scientists and contribute to the scientific growth of the R&D department.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical formulation development.
- Proven expertise in developing various dosage forms and understanding drug delivery principles.
- Hands-on experience with formulation characterization techniques and analytical instrumentation.
- Knowledge of regulatory requirements (e.g., FDA, EMA) for drug product development.
- Strong understanding of GMP principles.
- Excellent experimental design, problem-solving, and data analysis skills.
- Effective communication and interpersonal skills, with the ability to collaborate effectively.
- Experience with solid-state characterization and stability studies.
- A proactive approach and a commitment to innovation in drug development.
Senior Formulation Scientist, Drug Discovery
Posted 1 day ago
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Job Description
- Designing and executing studies for the development of various dosage forms (e.g., oral solid dosage, injectables, topical formulations).
- Investigating and selecting appropriate excipients and drug delivery technologies to optimize drug performance and bioavailability.
- Developing robust and scalable formulation processes.
- Characterizing formulated drug products using various analytical techniques (e.g., HPLC, dissolution testing, particle size analysis).
- Conducting stability studies and analyzing results to determine shelf-life and storage conditions.
- Troubleshooting formulation challenges and identifying potential solutions.
- Collaborating with analytical development, biology, and chemistry teams to achieve project goals.
- Preparing comprehensive formulation development reports and contributing to regulatory filings.
- Staying abreast of the latest advancements in pharmaceutical formulation and drug delivery.
- Mentoring junior scientists and contributing to the scientific advancement of the department.
- Ensuring all research activities are conducted in compliance with GxP guidelines.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical formulation development.
- Proven experience with the development of multiple dosage forms, including solid dosage and/or parenteral formulations.
- Strong understanding of physical chemistry, material science, and drug delivery principles.
- Proficiency with analytical techniques relevant to formulation characterization and quality control.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong written and verbal communication abilities, with experience in report writing.
- Ability to work independently and manage multiple projects simultaneously in a remote setting.
- Experience with regulatory requirements for drug development is a plus.
- A collaborative spirit and a commitment to scientific rigor.
Senior Formulation Scientist, Drug Development
Posted 3 days ago
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Job Description
Senior Formulation Scientist, Drug Development
Posted 4 days ago
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Job Description
Responsibilities:
- Design, develop, and optimize novel drug formulations for various dosage forms (e.g., oral solids, injectables, topicals).
- Conduct pre-formulation studies to characterize active pharmaceutical ingredients (APIs) and excipients.
- Develop and validate analytical methods for drug product testing and stability studies.
- Scale up formulations from laboratory bench to pilot and commercial manufacturing.
- Prepare comprehensive formulation development reports, protocols, and CMC (Chemistry, Manufacturing, and Controls) documentation.
- Collaborate closely with process development, analytical development, regulatory affairs, and project management teams.
- Troubleshoot formulation and manufacturing challenges.
- Stay current with scientific literature, industry trends, and new technologies in pharmaceutical formulation.
- Conduct literature reviews and feasibility studies for new drug candidates.
- Ensure all activities comply with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
- Present scientific findings and project updates to internal teams and external stakeholders.
- Mentor junior scientists and provide technical guidance.
- Contribute to intellectual property generation through patent applications.
- Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- Minimum of 5-7 years of experience in pharmaceutical formulation development, with a proven track record of bringing drug products through development stages.
- Extensive knowledge of various dosage forms and drug delivery technologies.
- Experience with GMP manufacturing environments and regulatory submission processes (IND, NDA).
- Proficiency in common laboratory equipment and analytical techniques (e.g., HPLC, dissolution testing).
- Strong understanding of material science, physical chemistry, and biopharmaceutics.
- Excellent problem-solving, analytical, and critical thinking skills.
- Exceptional written and oral communication skills.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Experience with sterile product formulation and aseptic processing is a plus.
Senior Formulation Scientist - Drug Development
Posted 4 days ago
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Senior Formulation Scientist (Drug Delivery)
Posted 7 days ago
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Associate Director, Formulation Development, Drug Product
Posted 24 days ago
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Job Description
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.
- Lead and review drug product development activities with line management 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.
- Lead 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.
- Ensure seamless transfer of knowledge and responsibilities to late-stage Process Development leads as programs progress to later stages of development
- 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.
- Bachelor's degree required within scientifically relevant field (Engineering, Chemistry, etc.), (MS / PhD is strongly preferred)
- 8+ years of relevant pharmaceutical industry experience in small molecule formulation development, process development, and product characterization across various dosage forms, including oral solids, oral liquids, or topical gels.
- 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 required
- 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.
- 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.
- 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 seven 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
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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Senior Formulation Scientist - Novel Drug Delivery
Posted today
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We require a Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a closely related field. Significant experience (5+ years) in pharmaceutical formulation development, particularly with parenteral or oral solid dosage forms, is mandatory. Expertise in techniques such as lyophilization, microencapsulation, nano-suspensions, and solid dispersion technologies is highly desirable. Strong knowledge of drug degradation pathways, excipient compatibility, and analytical methods for characterization (HPLC, DSC, XRPD) is essential. Excellent leadership, communication, and project management skills are required to guide formulation projects and collaborate with R&D, manufacturing, and regulatory affairs teams. This role offers a chance to contribute to the development of life-changing therapies in a collaborative and innovative environment, with a competitive compensation and benefits package.