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Crinetics Pharmaceuticals · 10 hours ago

Associate Director, Drug Product Development

San Diego, CA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$154K/yr - $192K/yr

7+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. The Associate Director of Drug Product Development will manage activities related to preformulation, biopharmaceutics, and formulation development from Phase 1 to commercial launch, playing a crucial role in the development of therapeutics for rare endocrine disorders.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Integrate biopharmaceutics principles to guide drug product design and development, ensuring clinically meaningful formulation strategies

Design and develop formulation and processes to enable clinical studies with the desired performance

In collaboration with DMPK and Clinical Pharmacology, develop and apply advanced modeling-informed strategies (e.g., PBPK) to predict drug dissolution, absorption, bioavailability, enabling formulation optimization, bridging decisions, and risk mitigation

Design and execute experiments for development of rational, scientifically sound, phase appropriate formulations and manufacturing processes including biorelevant conditions to simulate in vivo performance

Utilize software tools such as GastroPlus to model gastrointestinal physiology and inform formulation decisions

Apply deep understanding of physiological factors (e.g., GI pH, transit times, regional absorption) to interpret human and animal clinical data, linking dissolution behavior to in vivo drug performance and guiding formulation refinement

Contribute biopharmaceutics expertise to regulatory submissions, including IVIVC (In Vitro–In Vivo Correlation) and MIDD (Model-Informed Drug Development)

Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements

Plan, direct, and oversee formulation, process development, manufacturing, and packaging activities at contract development and manufacturing organizations (CMOs)

Evaluate and select external partners for drug product development and manufacturing

Prepare Drug Product development and manufacturing timelines and set clear deliverables for projects

Prepare and review request of proposal (RFPs), statements of work (SOWs), and associated budgets

Prepare and review regulatory filings (IBs, INDs, IMPDs, NDAs, briefing packages)

Author and review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure compliance with cGMP and company standards

Qualification

PhD in PharmacokineticsPBPK modeling expertiseGastroPlus proficiencyRegulatory submissions experienceDissolution testing methodologiesCGMP knowledgeAnalytical skillsProblem-solving skillsCommunication skills

Required

A PhD in Pharmacokinetics, Pharmaceutical Science, or a related field with at least 7 years of related technical experience in the small molecule biopharmaceutical industry

Experience supporting regulatory submissions with biopharmaceutics expertise

Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp

Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions

Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization

Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling

Lead work experience in drug product development and clinical manufacturing for small molecules

Excellent analytical, problem-solving, and communication skills