Scientific Director, Analytical Development

Neurocrine Biosciences Inc.-posted about 1 month ago

Full-time • Mid Level

San Diego, CA

1,001-5,000 employees

Chemical Manufacturing

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Recognized as a scientific expert and leader in advanced analytical technologies for Chemistry, Manufacturing and Controls (CMC) development. Serve as an analytical lead leading multiple projects and/or lead a sub-team in analytical development to guide analytical activities. Develops strategy and driving execution for analytical activities internally and externally associated with process and formulation development in support of clinical manufacturing of drug substance and drug product for small molecule and peptides drug candidates to support preclinical studies, clinical development, registration, and commercialization. Provides scientific leadership for junior scientific staff. Serves on cross functional CMC teams responsible for analytical related CMC strategy and deliveries, including regulatory submissions. Responsible for development and implementation of analytical control strategies including specification setting and method development, with special emphasis on innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

Leads analytical development activities for small molecules and peptides and serves as the analytical representative for cross-functional technical development teams which will include representatives from pre-formulation, formulation development, synthetic process development, manufacturing, regulatory CMC and quality assurance organizations
Oversees analytical method development, validation and transfer, specification strategy, GMP testing, and stability studies for drug substance and drug product internally and externally
Directs the use of established and new techniques including HPLC/UPLC, LC-MS, GC, spectroscopy, NMR, dissolution, wet chemistry, physical characterization techniques (e.g., PXRD) to generate and interpret data
Solves complex problems and devises control strategies to ensure drug substance and drug product quality
Effectively interacts with multiple functions across the organization and effectively communicates results and strategies to staff and company executives
Key contributor to and a resource for CMC sections in regulatory dossiers
Leads external relationships with contract development and manufacturing organizations (CDMO) to drive analytical activities, including method transfer, batch release, and stability studies
Manages physicochemical characterization of drug substance and related compounds
Coaches team members and establishes a high performing team environment
Overseeing analytical method development and characterization for small molecules and peptides
Other duties as assigned

BS/BA degree in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 12+ years' experience the pharmaceutical industry, including managing pharmaceutical analytical method testing, qualification, and troubleshooting. Experience in assessing technical data to provide technical reviews of analytical data, documents, and regulatory submissions. Extensive previous managerial experience also required OR
Masters in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 10+ years of similar experience noted above OR
PhD in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 7+ years of similar experience noted above
Ability to oversee and manage multiple programs/projects and being more independent on daily interactions with internal functional teams and external analytical CDMOs
Proven success managing internal/external lab personnel
Expert knowledge of analytical method development, method validation, and characterization of drug substances, drug products, and related substances
Demonstrated expertise in key technologies such as HPLC/UPLC, LC-MS, GC, spectroscopy, solid state characterization, and dissolution
Strong knowledge of ICH, FDA and EMA guidance for analytical method validation, stability, CTD, and submission of analytical data
Ability to assess technical data to provide oversight of technical reviews of analytical data, documents, and regulatory submissions
Broad knowledge of formulation development for drug products with various dosage forms
Strong knowledge of cGMPs, including CMC regulatory information required for INDs/NDAs/ANDAs with respect to drug substance, pre-formulation, formulation, analytical methods, and dosage form manufacturing processes
Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
Applies in-depth knowledge of technical expertise and pharmaceutical development to solve critical issues having cross-functional impact
Ability to effectively interact with multiple functions across the organization, and effectively communicate results and strategies to staff and company executives
Strong attention to detail, excellent written and oral communication skills
Strong leadership, coaching, employee development skills
Ability to work in a cross functional team and matrix environment and influence others with or without authority at all levels of the organization
Proactive, innovative, with good problem-solving skills
Excellent written, presentation, and verbal communication skills

Knowledge in analytical methodologies for characterizations of large molecules including peptides, proteins, and antibodies is a plus

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.

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