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Internetwork Expert
South San Francisco, CA, United States
Frontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier’s South San Francisco office. The successful candidate will lead internal and external resources to develop scalable manufacturing processes for Frontier’s small molecule pipeline. The role will include oversight
Job Source: Internetwork ExpertFrontier Medicines
South San Francisco, CA, United States
Frontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier's South San Francisco office. The successful candidate will lead internal and external resources to develop scalable manufacturing processes for Frontier's small molecule pipeline. The role will include oversight
Job Source: Frontier MedicinesExelixis
Alameda, CA, United States
SUMMARY/JOB PURPOSE: The Director, Medicinal Chemistry is a highly skilled and motivated senior-level medicinal chemist who manages our small molecule drug discovery team. The ideal person is an exceptional chemistry team leader, overseeing a team of chemists to design and synthesize novel compounds for portfolio projects. ESSENTIAL DUTIES AND RESP
Job Source: ExelixisExelixis
Alameda, CA, United States
SUMMARY/JOB PURPOSE: The Director, Medicinal Chemistry is a highly skilled and motivated senior-level medicinal chemist who manages our small molecule drug discovery team. The ideal person is an exceptional chemistry team leader, overseeing a team of chemists to design and synthesize novel compounds for portfolio projects. ESSENTIAL DUTIES AND RESP
Job Source: ExelixisExelixis, Inc.
Alameda, CA, United States
Director, Medicinal Chemistry page is loaded Director, Medicinal Chemistry Apply locations Alameda, CA time type Full time posted on Posted 4 Days Ago job requisition id JR5647 SUMMARY/JOB PURPOSE: The Director, Medicinal Chemistry is a highly skilled and motivated senior-level medicinal chemist who manages ou
Job Source: Exelixis, Inc.Alector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorAlector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorEMSL Analytical Inc.
San Leandro, CA, United States
EMSL Analytical Inc. Senior Analyst (Chemistry) San Leandro , California Apply Now EMSL is seeking a Senior Analyst (Chemistry) in San Leandro, CA. This position involves preparing and analyzing metals samples using a variety of chemistry instrumentation. Responsibilities include but are not limited to:Prepare and analyze samples to q
Job Source: EMSL Analytical Inc.San Francisco, CA, United States
Senior Director, Process Chemistry
Technical Operations
The Senior Director, Process Chemistry leads the process scientists and is responsible for the process development and supply of small molecule drug substance (API) for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities. All GMP aspects of the development projects are carried out entirely by outsourcing to various contract research or manufacturing organizations (CRO/CMO). You will be required to mentor scientists and direct experiments conducted in-house to optimize the synthetic routes and the manufacturing processes of various APIs in the pipeline.
MAJOR DUTIES AND RESPONSIBILITIES:
Develop overall API strategy, timelines, budgets, risks & mitigations plans of all process development, starting materials, and manufacturing campaigns
Execute on supply chain strategy for late stage (Phase 2 through NDA stage) clinical supply
Lead process improvement and clinical batch manufacturing for various early to late-stage API projects at the CMO
Manage development activities including scale up and technology transfer at the CMO
Develop a control strategy, process acceptance ranges, operating ranges, and documents in preparation of the validation campaign
Collaborate with multiple groups within the organization to support the development of the API supply chain in preparation for the NDA and commercial launch
Select CMOs for project-specific activities
Work with contract research organizations to optimize the crystallization process for the last synthetic step of the API
Identify source for starting materials and intermediates, and develop plans for consistent and continuous supply
Identify key process parameters and relevant in-process controls
Derive origins of process impurities and steps for their control, mechanistic studies of reactions when needed, and actively work with contract research organizations on synthesis or isolation of process impurities
Represent process chemistry at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
Lead the authorship of appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions
Act as the technical subject matter expert (SME) internally for troubleshooting process chemistry issues
Review and approve batch documents for drug substance manufacturing
Maintain process trend data to understand process changes
Interact with outside patent counsel in helping to draft patent applications for any new chemistry
Work with project teams to identify drug substance requirements, manage and optimize aggressive project timelines, oversee the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered
Other duties as assigned
Travel: Up to 20%
EDUCATION REQUIREMENTS
PhD, Organic Chemistry or Chemical Engineering
EXPERIENCE REQUIREMENTS
Pharma/biotech industry experience in pharmaceutical process development and drug substance manufacturing preferably at a commercial level for small molecules (minimum 15 years with an MS, 10 years with a PhD)
Advanced pharmaceutical organic chemistry skills combined with exceptional project leadership, organization, and communication skills.
A minimum of 3 years’ experience in supervising direct reports
OTHER QUALIFICATIONS
Ability to work independently in a fast-paced environment
Thorough knowledge of process chemistry and scale-up with a proven track record in developing and implementing robust and efficient drug substance manufacturing processes
Experience handling technology transfer and technical support including OOS, deviations, and troubleshooting of drug substance manufacturing processes
Extensive experience collaborating with and overseeing CMOs and third-party manufacturers
Experience handling process capability studies to support process validation in drug substance manufacturing
Ability to validate late-stage or commercial manufacturing drug substance processes and a proven track record in cGMP manufacturing
Broad knowledge of regulatory (ICH) and cGMP requirements for pharmaceutical products
Experience reviewing and/or authoring CMC section for regulatory submissions
Exceptional communication, collaboration, and problem-solving skills ensuring alignment with other functions
PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS
Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally.
Visual Acuity - Perform activities such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
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Email Alert for Senior Director Process Chemistry jobs in San Francisco, CA, United States
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