Scientist - Method Development
Proclinical is currently recruiting for a Scientist of Method Development with a leading biopharmaceutical company located in Boston, MA. As the Method Development Scientist, you will write and develop method validation protocols, reports and test methods.
- Performs method validation protocol activities in the laboratory.
- Review of method validation protocol data.
- Performs routine and stability testing in the laboratory.
- Review of release, stability and characterization data, including technical review of change control documentation and reports, deviations, and OOS;
- Assist in outsourcing of release and stability test methods, including test method transfer, assay qualification and troubleshooting;
- Collaborate with Analytical Development on identifying, developing and qualifying test methods to support phase-appropriate product release and stability testing.
- Work collaboratively with Upstream PD, Downstream PD, Analytics, and Research groups to develop an increased depth of knowledge of processes and identify improvement opportunities.
- Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
- Generate complete, accurate, and concise laboratory documentation.
- At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.
Skills and Requirements:
- BS and/or MS degree in biochemistry, cell biology and/or molecular biology discipline;
- At least 6 years work experience in a GMP environment;
- Background in analytical method development, analytical support of manufacturing campaigns, quality control, and method transfer;
- Background in methodologies supporting both biologics and small molecules;
- Direct experience in authoring and review of SOPs, assay qualification protocols and reports;
- Strong knowledge of cGMP/ICH/FDA/EU regulations;
- Work with minimal supervision, demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments leading to innovative solutions;
- Strong work ethic, strives to learn new things, and capable of working independently and in a collaborative environment;
- Excellent communication, project management, and presentation skills (oral and written);
- Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.