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The Director, Drug Product Development will support development and manufacturing activities at various CDMO partners and ensures that drug product supplies are available in a timely manner at various stages of clinical development.

Responsibilities & Duties

• Manage formulation and process development activities for solid oral drug products at CDMO partners and collaborate with internal stakeholders in the development and manufacturing of drug products to ensure program timelines are met.
• Develop and implement comprehensive strategies for early-stage formulation and process development including solid form characterization, pre-formulation, interpretation of data from preclinical studies, evaluation of multiple formulation options, process design and optimization, scale-up, and manufacturing of drug product under both non-GMP and cGMP.
• Lead high throughput screening of excipients, selection of primary drug container closure systems, identification of degradation pathways, and development of stable formulations.
• Support development of immediate release and extended-release formulations for various compounds including compounds with solubility and stability challenges.
• Demonstrate a thorough understanding of relevant technical/scientific literature, standard procedures, and pharmaceutical regulations relevant to the programs.
• Identify and mitigate technical risks associated with formulation development and manufacturing. Anticipate manufacturability challenges associated with drug product development.
• Write and review manufacturing batch records, deviations, change controls, reports, IND, and NDA module documents for drug products.
• Work closely with Quality team to support quality related events such as change controls, deviations, etc. to ensure timely review and implementation.
• Review and provide guidance on quality aspects across regulatory filings related to specifications, acceptance criteria, and stability protocols.
• Write and review study protocols and reports (both formal and informal) to support product development studies and regulatory filings.
• Maintain scientific records in clear required form.

Qualifications & Skills

• PhD. in Pharmaceutics or scientifically related field or M.S. with additional professional experience.
• 10+ years of related formulation development experience focused on solid oral dosage forms for small molecules.
• Oversight of CDMOs for development and cGMP activities from preclinical through Phase 3.
• Knowledge and proficiency using experimental design and statistical analysis software. (e.g., JMP, DesignExpert, etc.)
• Experience with IND and NDA-related filing activities is desired.
• Thorough understanding on pharmacokinetic data interpretation from preclinical and clinical is a plus; Familiarity with various modeling methods (e.g., GastroPlus®, etc.)
• Familiarity with regulatory requirements for pharmaceutical development.
• Subject matter expert with exceptional command of scientific literature in the field and related disciplines.
• General and scientific computer and software application proficiency.

Company benefits include:

• Medical, dental, vision, and life insurance
• 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• New hire stock options
• Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
• Leave of Absence: Paid family leave, paid short- and long-term disability
• Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $203,304- $219,402