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1+ months

Associate Director/Director of Drug Process Development

Kelly Services
South San Francisco, CA 94080
**Kelly Services is actively recruiting for a Remote Associate Director/Director of Drug Process Development for a Direct Hire opportunity in Greater South San Francisco area, CA.**


**Overview**


The successful candidate will be accountable for performance and results including: the development and characterization of chemical processes, technical transfer to CMOs, oversight of cGMP manufacture, and representation on CMC teams. As a leader within the process chemistry function, the successful candidate will contribute their technical expertise across multiple projects, maintain expertise by benchmarking current industry trends in process chemistry, and drive the optimization of operational procedures.


**ACCOUNTABILITIES**


Ensure technical deliverables for drug substance projects (process development work captured in technical reports, tech transfer and cGMP productions, process characterization consistent with QbD principals, and process validation as appropriate).


+ Understanding and influencing the development of analytical methods and specifications needed to support process research and development of small molecules


Contributes significantly to develop, drive, and set vision and direction of process chemistry activities, management of resources, time, and financial resources.


Serves as a technical resource to guide in strategic decision making and conducts analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.


+ Selecting and working closely with external CMO's to help set technical expectations and deliver cGMP compliant process development.


Monitors industry trends and recommends and implements new technologies and innovations to deliver upon process chemistry goals as appropriate.


+ Understanding and influencing the CMC regulatory environment to provide a phase appropriate strategy supporting process development along with the authorship of IND's, NDA, and the small molecule Drug Substance section of module 3.


Develops discipline/departmental plans/initiatives and drives strategy and implementation for process chemistry, creating linkages with strategies of other relevant functions. Contributes to cross-departmental strategy and identifies topics for initiatives and leads local/global department and cross-department initiatives with accountability for performance and results. Communicates efforts with senior management of other functions as appropriate.


**EDUCATION, EXPERIENCE AND SKILLS:**


**Required:**


BS or MS degree in chemistry-related science with 8+ years relevant industry experience or PhD in chemistry related science with 5+ years relevant industry experience.


Advanced understanding of results generated from typical process chemistry analytical tools (e.g., HPLC, NMR, GC-MS).


Proficiency with utilizing typical literature searching techniques to solve organic chemistry problems.


Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMPs including a proven track record of scale up API synthesis.


Sound knowledge of current Good Manufacturing Practices (cGMP) including a scale up safety understanding.


Experience in working in a standalone, multi-disciplinary environment with accountability for informing departmental or functional strategy.


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**\#TJP2022_SPEC**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-16 Expires: 2022-07-25

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Associate Director/Director of Drug Process Development

Kelly Services
South San Francisco, CA 94080

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