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Sr. Manager/Associate Director, CMC Development - South San Francisco, United States - Frontier Medicines
Description
Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at our South San Francisco office.
As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role in advancing our small molecule pipeline.
Your responsibilities will include driving the development and manufacturing of drug substances, overseeing both internal and external resources, and collaborating closely with CDMOs to ensure the successful progression of our innovative compounds.
Frontier Medicines offers a dynamic environment with the opportunity to impact the lives of patients while conducting cutting-edge science.There are short communication lines across the company, and we encourage and support the professional development of our team members.
This individual will play an essential role in Frontier's to support both the Boston and the South San Francisco offices.
RequirementsWhat will you be doing?
Lead and oversee all aspects of process chemistry, ensuring the development, optimization, and scale-up of robust chemical processes for the manufacture of drug substance
Managing daily pre-formulation/material assessments of API and preclinical formulations
Fostering collaboration with CMC and Discovery R&D teams
Conducting development studies, interpreting results, and suggesting follow-up actions independently
Overseeing drug substance process development and manufacturing
Coordinating drug substance program management
Engaging with CROs/CDMOs and identifying new technologies
Ensuring comparability assessments and cultivating vendor relationships
Supervising third-party activities and delivering project updates with recommendations
Traits we believe make a strong candidate:
PhD. in Pharmaceutical Chemistry, Materials Science, Medicinal Chemistry with 5+ years, MSc. with 8+ years, or BS with 10+ years of experience in small molecule drug substances and drug products
Project Management experience considered advantageous
Proven ability to work independently, multitask effectively, and manage a diverse range of projects simultaneously.
Experience with quality by design (QbD), process validations and statistical design of experiments (DOE) is preferred
Experience with early through late-stage process development is strongly preferred
Team player who will be able to collaborate effectively in a cross-functional matrix team environment including Safety Assessment and DMPK groups
Exceptional oral communication and writing skills
A thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required
Ability to travel domestically and/or internationally to achieve goals, when required
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Family Leave (Maternity, Paternity)
Short Term & Long Term Disability
Training & Development
Free Food & Snacks
Wellness Resources
Stock Option Plan
At Frontier we strive to build a diverse and equitable workplace. The salary range for this role is $140,000 - $185,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.
This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.
