About the Role:
Represent Preformulation and Pharmaceutical Development within Technical Operations by collaborating on project teams from early discovery through development, predominately focusing on pre-FIH molecules in a fast-paced non-GMP environment. The candidate will develop phase appropriate fit-for-purpose analytical methods, design and execute preformulation studies for multiple preclinical/clinical programs, identify developability risks for potential development candidates. Additionally, this role is responsible for authoring and reviewing technical documentation including regulatory submissions and scientific reports. Success in this role will require sound technical judgment, the ability to identify development risks, implementation of innovative analytical technologies, and effectively communicate complex scientific findings to multidisciplinary teams to support R&D decision-making.

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Your Contributions (include, but are not limited to):

• Collaborate with Research/Discovery, Preclinical & Clinical Pharmacology, and Technical Operations to facilitate communication, ensuring emerging and updated pharmaceutical development data is shared widely and used effectively by the broader R&D Team

• Design and develop phase appropriate analytical methods (HPLC-UV, LC-MS, MS-MS, SEC-HPLC, etc.) studies in support of early pharmaceutical development activities

• Design and execute studies in support of developability assessments (i.e. thermodynamic & kinetic solubility, chemical & physical stability, excipient compatibility, etc.), preclinical formulation development, and support molecule/form selection

• Research new instrumentation and analytical technologies to be implemented when needed for development support

• Scientific review of electronic lab notebooks, technical development reports, stability summaries, DFA memos, regulatory submissions, and other relevant documentation

• Assemble and/or maintain information repository to allow efficient retrieval of early pharmaceutical development data, physiochemical properties, and scientific knowledge regarding molecules in the R&D pipeline

• Present updates at department meetings and deliver scientific talks on current and new techniques/technology in support of early pharmaceutical development

• Lead or participate in weekly or bi-weekly project team meetings and inform both up and down the chain of command as to progress, resource gaps, and timelines

• Other duties as assigned

Requirements:

• BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field AND 4+ years of pharmaceutical industry experience, including experience in a chemistry, analytical, or characterization laboratory setting OR
• MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field AND 2+ years of similar experience noted above OR
• PhD in Chemistry, Biochemistry, Chemical Engineering, or related field AND some relevant experience; may include postdoc experience
• Demonstration of cross-functional understanding related to molecule selection and drug development is strongly preferred
• Must have technical expertise in analytical method development and preformulation sciences
• Technical expertise in LC-MS is strongly preferred
• Working knowledge of Agilent OpenLab software is a plus
• Expertise with fit-for-purpose method development and phase appropriate method qualification/ validation to determine solubility, stability, and other pharmaceutically relevant properties of novel therapeutics (including small molecules, peptides, and other biologic modalities)
• Familiarity with a variety of pharmaceutical dosage forms (parenteral, oral solutions/suspensions, SDD, HME, SEDDS, etc.) to design appropriate developability studies and identify potential development risks
• Strong knowledge of regulatory guidelines in preparing and authoring the drug product sections of INDs/CTAs and NDAs/BLAs
• Strong knowledge and expertise of the following instrumentation and techniques is required; HPLC (SEC, UV, MS, IEX, etc), Open Lab software, solubility analysis, pKa determination, Log P/D, and other preformulation studies
• A working knowledge of the following is required; DSC, TGA, PXRD, NMR, Particle-Size Analysis, GVS, PLM, and SEM
• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
• Strong knowledge of scientific principles, methods and techniques
• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• 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 problem-solving skills and the ability to adapt to changing priorities and deadlines
• Demonstrated ability to complete technical assignments by supporting the design, execution and interpretation of complex experiments
• Ability to deliver results within defined budget, timing, and resources constraints. Awareness of impact(s) on other functional areas
• Self-motivated and comfortable working as part of a cross-functional teams, and an ability to meet timelines efficiently and productively
• Ability to monitor on-going experiments and suggest alternatives or solutions
• Advanced knowledge with Excel, Word, PowerPoint and other associated software used in the scientific field
• Excellent verbal and written communication skills
• Advanced planning, organization and time management skills including the ability to support and prioritize multiple projects

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The annual base salary we reasonably expect to pay is $110,800.00-$151,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.