Job Description Summary: The Scientist II, Formulation Development actively contributes to drug discovery and drug product development by designing, manufacturing, and characterizing phase-appropriate formulations and process; ensuring a timely supply of formulations or drug product for discovery, preclinical, and clinical studies. This involves performing lab activities, analyzing the data, planning studies and communicating lab results to cross-functional team members and line management, and presenting results to stakeholders as required.
The incumbent works cross-functionally with internal departments and external partners on formulation development related issues.
The Scientist II, Formulation Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:ESSENTIAL FUNCTIONSPrimary duties/responsibilities:
- Designs and develops robust formulations and manufacturing processes for small molecule compounds from drug discovery and/or development programs for preclinical and clinical studies.
- Prepares experimental designs, evaluates data, coordinates and executes pre-formulation, formulation, and process development studies and identifies pharmaceutical development challenges, and recommends potential solutions.
- Conducts pre-formulation and formulation studies using various techniques (TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH, etc.).
- Works with internal and external partners as necessary to meet formulations needs.
- Develops safe, viable and robust formulations using pharmaceutically acceptable inactive ingredients that enable the delivery of water insoluble compounds by multiple routes of administration.
- Conducts formulation and process technology transfers to external partner sites and monitors activities at CDMOs to meet PTC's project timelines.
- Designs studies and conducts phase-appropriate risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
- Conducts formulation & process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools.
- Provides pre-formulation, formulation, and manufacturing support for drug product formulation development; and for the transfer of formulation development to contract manufacturing organizations, as necessary.
- Independently oversees the maintenance and calibration of laboratory instrumentation within the group (TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH, etc.).
- Maintains safe laboratory working conditions and maintains a steady uninterrupted supply of raw materials, reagents, supplies, and any required tools as necessary.
- Summarizes experimental work in reports, presents the study plans and results to broader teams in a timely manner.
- Authors the drug product sections of regulatory submissions such as Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), or their amendments, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) as necessary.
- Maintains appropriate experimental records in laboratory notebooks.
- Mentors and coaches junior team members.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIREDMinimum level of education and years of relevant work experience:
- PhD degree in pharmaceutical science, material science, chemistry or other related scientific discipline with minimum 2 years of relevant experience OR Master's degree in these same disciplines with min 4 years of relevant experience OR a Bachelor's degree in these same disciplines and a minimum of 6 years of relevant experience in discovery formulation, pre-formulation or formulation development in a pharmaceutical, biotechnology or other related environment.
Special knowledge or skills needed and/or licenses or certificates required:
- Hands-on experience and demonstrated proficiency with basic laboratory skills, design, development, and characterization of liquid and solid dosage forms using formulation equipment such as blenders, granulators, roller compactors, tablet presses, coaters, fluid-bed dryers etc.
- Proven understanding of physical pharmacy & engineering concepts in formulation and process development and related scale-up principles.
- Proficiency in working with and overseeing CMOs for formulation development and manufacture for PTC projects is desirable.
- Proficiency with Microsoft Office applications.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Special knowledge or skills and/or licenses or certificates preferred:
- Familiarity with the preparation of formulations for drug discovery and clinical support by both oral and parental routes of administration.
- Understanding of physical chemistry and physical pharmacy as they relate to concepts in preformulation and formulation.
- Experience using electronic lab notebook.
- Hands-on experience using and troubleshooting analytical instruments (e.g., High Pressure Liquid Chromatography (HPLC), differential scanning calorimetry (DSC), light microscopy, Karl Fisher (KF), X-ray diffractometer), hot stage microscopy, thermogravimetric analyzer (TGA), etc.
- Working knowledge of US and international Chemistry, Manufacturing and Control (CMC) regulations and guidance, including Good Manufacturing Practice (GMP), the US Code of Federal Regulations (21CFR) and International Conference of Harmonization (ICH) guidelines is desired.
Travel requirements:
Expected Base Salary Range:
- $133,100- $158,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
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