- Use data and risk-based approaches to commercial route and process innovation and selection by incorporating principles of green chemistry and process safety in concert with regulatory requirements.
- Develop clinical supply manufacturing strategy, integrated with phase and regulatory appropriate route and process improvements.
- Manage and coordinate outsourcing efforts at external CROs and CDMOs to ensure high quality and on-time execution.
- Serve as technology lead for process technology transfers.
- Collaborate with Drug Product and Analytical colleagues to ensure the Drug Substance physical attributes are understood, controlled, and are appropriate for Drug Product manufacturing.
- Prepare for and execute process characterization with cross-functional colleagues, utilizing Quality by Design principles.
- Ensure stage appropriate data is generated and documented, serve as lead author of Drug Substance sections of regulatory filings.
- Collaborate effectively with internal and external stakeholders to deliver on program objectives.
- Ph.
- Experience with:
- Deep understanding of small molecule drug development; understand how CMC disciplines integrate and partners with associated functional areas such as Risk Management and Quality, Drug Safety, Clinical, Regulatory, Intellectual Property Protection, and Contracts.
- In-depth familiarity with phase based GMPs and manufacturing compliance requirements, regulatory guidelines and expectations.
- Willingness and ability to work hands-on and with a sense of urgency in a fast-paced, agile environment.
- Ability to manage ambiguity, think critically, and make sound, risk-based scientific and business decisions when there is limited information.
- Ability to conduct, manage, and communicate risk assessments.
- Passion about learning and development to help build a dynamic company at the cutting edge of Targeted Protein Degradation.
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Director, Drug Substance Development - Watertown, United States - Kymera Therapeutics, Inc.
1 week ago
Description
Who we are:
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives.
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer.
Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years.For more information about our science, pipeline and people, please visit or follow us on X (formerly Twitter) or LinkedIn.
How we work:
*PIONEER: We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines.
*COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
*BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you'll contribute:
As a Director of Drug Substance development, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the process chemistry representative on our integrated CMC team for late-stage (post Phase 1) development and manufacturing.
What skills and experience you'll bring:
o Serving as the Drug Substance lead on fully integrated Chemistry, Manufacturing, and Control (CMC) teams.
o Late-stage optimization, process characterization, registration, and validation.
o Building the Drug Substance data package for, and composition of a New Drug Application (NDA).
o Directing and managing CRO and CDMO partners.
Skills and experience not an exact match?:
Go ahead and submit your resume (and a cover letter, if you'd like). If this role isn't right for you, we can keep you in mind for future opportunities.
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.
All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
