Description
Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or 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.
This is a remarkable opportunity to contribute significantly to the field of drug development while leading a dynamic team. If you're passionate about making a tangible impact in the pharmaceutical industry, we invite you to join us in this exciting endeavor.
Requirements
What will you be doing?
- Managing daily pre-formulation/material assessments of API and preclinical formulations
- Lead the development of appropriate analytical test methods and stability studies for drug product formulationsLead analytical activities for preclinical and early clinical activities.
- Plan and conduct experiments on pre-formulation, characterization of API and the design of formulations such as suspensions, solutions, tablets, capsules, and spray dried dispersions.
- Fostering collaboration with CMC, DMPK, Chemistry and Discovery R&D teams
- Conducting development studies, interpreting results, and suggesting follow-up actions independently
- 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, Analytical 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 analytical cheistry techniques, solubility determination, compatibility studies, formulation screening, dissolution, polymorph screening and physicochemical characterization of API as well as formulations.
- Experience with early through late-stage process development is strongly preferred
- Experience with quality by design (QbD), process validations and statistical design of experiments (DOE) is 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 $165,000 - $200,000. 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.
