Description
Senior Process Development Engineer
Location: Concord, Ohio (Relocation Available)
Salary: $100,000 - $130,000 per year
POSITION SUMMARY
Seeking a highly experienced Senior Process Development Engineer with deep expertise in pharmaceutical API manufacturing through chemical synthesis. This role focuses on the scale-up of processes from R&D to commercial production, including multi-kilogram batch sizes and validation activities. The ideal candidate will have at least 10 years of experience in pharma/API manufacturing and a strong background in process optimization and technology transfer within cGMP environments.
KEY RESPONSIBILITIES
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Lead scale-up activities for API chemical synthesis from lab scale to pilot and commercial production.
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Develop, author, and execute batch records, protocols, and validation documents for commercial manufacturing.
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Collaborate cross-functionally with manufacturing, QA/QC, and other departments to ensure seamless process implementation.
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Mentor and lead a team of engineers, including junior staff, providing technical guidance and support.
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Drive continuous improvement initiatives to optimize yields, throughput, and process robustness.
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Ensure compliance with regulatory standards such as cGMP, ISO, and FDA guidelines.
REQUIREMENTS
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Minimum 10 years of experience in pharmaceutical API manufacturing, specifically chemical synthesis.
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Hands-on experience with scale-up from R&D to commercial production batches (multi-kilogram scale).
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Strong knowledge of process development, technology transfer, and reaction calorimetry.
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Proficiency with analytical instrumentation (e.g., HPLC, GC, NMR, TGA, DSC) is highly desirable.
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Experience writing and managing validation and batch records in a regulated environment.
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Ability to lead and mentor engineering teams effectively.
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Excellent communication skills and ability to work cross-functionally.
ADDITIONAL INFORMATION
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Monday to Friday, 8 am to 5 pm work schedule.
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Opportunity for relocation assistance.
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Competitive salary range between $100,000 and $130,000 annually.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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