Job Description
Job Description
Our client is searching for a dynamic Contractor Process Chemist to join the growing Process Research and Development team.
The Senior Scientist / Principal Scientist will be able to follow programs as they proceed through development as supporting the overall drug substance development and manufacturing activities.
The successful candidate needs to demonstrate a proven track record of solving technical challenges while supporting GMP manufacturing.
Key Responsibilities
- Solve technical issues related to drug substance manufacturing by providing hands-on laboratory support within the chemical development group including process design, optimization, scale-up, process intensification, process characterization, and spike-and-purge studies to bring a clinical phase program to commercial readiness.
- Work with external CMO / CRO teams to enhance / support their laboratory experimentation
- Author internal technical reports based on in-house laboratory research and provide critical review of similar reports generated at external CMO / CROs
- Identify key knowledge gaps and execute plans to ensure process understanding is commensurate with a given program’s stage of clinical development
Minimum Requirements
- In-depth knowledge of synthetic organic chemistry
- MS or PhD in organic chemistry with 5+ years (MS) or 3+ years (PhD) of industry experience
- Demonstrated laboratory experience developing processes to produce small molecule pharmaceuticals from early to late-stage development
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- Effective verbal and written communication skills
- Demonstrated experience with organic chemistry instrumentation and interpretation including HPLC, LCMS, GC, NMR and applicable software (ChemDraw, Excel, Word, Powerpoint).
- Demonstrated proficiency to manage timelines by effective prioritization to meet project goals
Preferred Qualifications
- Working knowledge with DSC, TGA, and XRPD instrumentation and familiarity with Mettler Toledo equipment are preferred.
- Demonstrated scientific contribution to the synthetic community evidenced by presentations and publications
- Regulatory writing experience including IND / IMPD / NDA / MAA drug substance quality modules.
Company Description
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser : https : / / jobs.
beaconhillstaffing.com / eeoc /
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment.
This form will be used for reporting purposes only and will be kept separate from all other records.
Company Description
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
r n r nIf you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser : https : / / jobs.
beaconhillstaffing.com / eeoc / r n r nCompletion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment.
This form will be used for reporting purposes only and will be kept separate from all other records.