Director, Analytical Development
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
The Director, Analytical Development will report to the Senior Director, Analytical Development and Quality Control. This role is part of the Technical Operations team collaborating with external CROs and CDMOs to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. This position operates in a small company environment in San Diego’s biotechnology community, contributing to a fast-paced drug discovery and development effort. Responsibilities
Establish, direct, and monitor implementation of appropriate Tech Ops testing methodology and specifications for raw materials, intermediates, excipients, active pharmaceutical ingredients (APIs) and drug products (DPs), with focus on oral dosage Lead analytical development activities of the assigned projects and deliver business results for CMC/Tech Ops Analytical Develop departmental processes to achieve department and corporate goals. Focus on immediate and short-term ( Work closely with external CRO/CDMOs collaborators to advance method development, qualification, transfer, and validation for API and DP for advanced programs Provide detailed review and approval for protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification Review and approve analytical methods, specifications, change controls, deviations, investigations, out-of-trend and/or out-of-specification reports Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories Work in close collaboration with and supports other members of the Tech Ops team responsible for API and DP development and support to management, as necessary Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts Author and review CMC sections of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers) Author and/or review departmental related Standard Operating Procedures and guidelines, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMPs and company standards Effectively work with RA and QA on quality system to ensure up-to-date procedures, adherence, and compliance of vendors with cGXP regulations Participate as CMC/Tech Ops subject matter expert in quality audits Identify and promote opportunities to streamline in-house CMC analytical development activities Provide leadership, career management and personal development to direct reports Recruit and develop top talent. Align team to needs of the business Other projects (impurity identification and characterization, etc.) as deemed appropriate Qualifications
Bachelor’s degree in Analytical Chemistry or related field with 12+ years of progressively responsible experience in analytical development in biopharmaceutical development, or an advanced degree (MS or PhD) with a minimum of 10 years of relevant technical and industry experience A minimum of 8+ years in a supervisory role Work experience in a biotech or pharma company (with a focus on small molecules in late phase of development) and extensive experience in oral solid dosage forms is desired Experience in relationship management of Contract Research Organization and contract laboratories Extensive technical experience in analytical testing, method development and phase appropriate qualification/validation, characterization, and support of stability programs for small molecule API and oral DPs Proficient with techniques that include but are not limited to HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial Proficient in at least two other areas of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution) Successful record of managing analytical activities and overcoming challenges Experience in reviewing and analyzing release and stability data for trending, shelf-life and specification setting Solid understanding of CGLP and CGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with a focus on product development and manufacture, including stability requirements Extensive knowledge of CGMP, quality systems and industry standards and thorough understanding of requirements for products in late phase of development Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities Ability and interest in mentoring and/or managing others Flexibility within a rapidly changing environment and high attention to detail Well-developed organizational skills and detail oriented Additional Requirements
Travel up to 20% may be required Physical demands include sitting for long periods, occasional walking, and lifting up to 25 lbs
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The Director, Analytical Development will report to the Senior Director, Analytical Development and Quality Control. This role is part of the Technical Operations team collaborating with external CROs and CDMOs to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. This position operates in a small company environment in San Diego’s biotechnology community, contributing to a fast-paced drug discovery and development effort. Responsibilities
Establish, direct, and monitor implementation of appropriate Tech Ops testing methodology and specifications for raw materials, intermediates, excipients, active pharmaceutical ingredients (APIs) and drug products (DPs), with focus on oral dosage Lead analytical development activities of the assigned projects and deliver business results for CMC/Tech Ops Analytical Develop departmental processes to achieve department and corporate goals. Focus on immediate and short-term ( Work closely with external CRO/CDMOs collaborators to advance method development, qualification, transfer, and validation for API and DP for advanced programs Provide detailed review and approval for protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification Review and approve analytical methods, specifications, change controls, deviations, investigations, out-of-trend and/or out-of-specification reports Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories Work in close collaboration with and supports other members of the Tech Ops team responsible for API and DP development and support to management, as necessary Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts Author and review CMC sections of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers) Author and/or review departmental related Standard Operating Procedures and guidelines, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMPs and company standards Effectively work with RA and QA on quality system to ensure up-to-date procedures, adherence, and compliance of vendors with cGXP regulations Participate as CMC/Tech Ops subject matter expert in quality audits Identify and promote opportunities to streamline in-house CMC analytical development activities Provide leadership, career management and personal development to direct reports Recruit and develop top talent. Align team to needs of the business Other projects (impurity identification and characterization, etc.) as deemed appropriate Qualifications
Bachelor’s degree in Analytical Chemistry or related field with 12+ years of progressively responsible experience in analytical development in biopharmaceutical development, or an advanced degree (MS or PhD) with a minimum of 10 years of relevant technical and industry experience A minimum of 8+ years in a supervisory role Work experience in a biotech or pharma company (with a focus on small molecules in late phase of development) and extensive experience in oral solid dosage forms is desired Experience in relationship management of Contract Research Organization and contract laboratories Extensive technical experience in analytical testing, method development and phase appropriate qualification/validation, characterization, and support of stability programs for small molecule API and oral DPs Proficient with techniques that include but are not limited to HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial Proficient in at least two other areas of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution) Successful record of managing analytical activities and overcoming challenges Experience in reviewing and analyzing release and stability data for trending, shelf-life and specification setting Solid understanding of CGLP and CGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with a focus on product development and manufacture, including stability requirements Extensive knowledge of CGMP, quality systems and industry standards and thorough understanding of requirements for products in late phase of development Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities Ability and interest in mentoring and/or managing others Flexibility within a rapidly changing environment and high attention to detail Well-developed organizational skills and detail oriented Additional Requirements
Travel up to 20% may be required Physical demands include sitting for long periods, occasional walking, and lifting up to 25 lbs
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