Analytical Method Development Scientist

Analytical Method Development Scientist - Permanent - Onsite

Proclinical is seeking an Analytical Method Development Scientist to join a cutting-edge manufacturing company. This is a permanent role located in Bristol, PA.

Skills & Requirements:

• PhD degree with at least 1-3 years of relevant laboratory experience.
• No industry experience required
• Experience in method development/optimization, qualification and validation of analytical methods.
• Knowledge and experienced application of analytical technologies involving primarily HPLC separations, HPLC-MS, Capillary Electrophoresis, Western blots, Immunoassays (ELISA, bioassay) other analytical protein characterization methods.
• Knowledge of qualification design and implementation.
• Knowledge and experience in cGMP, ICH guidelines, USP, EP following STM's.
• Proven ability to work both independently and collaboratively.
• Must be eligible to work in the US.

The Analytical Method Development Scientist will:

• Develop and conduct independently and/or collaboratively all aspects of analytical methods to support process development, product pre-formulation studies, in-process monitoring, drug substance, and drug product testing.
• Provide expertise in some or all of the following methods: Separation based techniques such as: HPLC-MS, Capillary Electrophoresis, UHPLC- ELSD, and cell based assays such as ELISA Immunoassays, Western blots, Protein Titer (HPLC, ELISA and SPR), SoloVPE and other analytical protein characterization methods.
• Perform method development and pre-qualification, Draft test methods and protocol, design and execute phase appropriate qualification, review analytical documents such as test methods and protocols, lead method transfer to Quality Control laboratory.
• Adhere to good documentation practices.
• Act as an intellectual resource for his/her area of expertise by supporting assay troubleshooting and improve analytical methods as needed. Data interpretation and statistical analysis.
• Participate in strategic thinking, planning and communicates scientific data and concepts effectively.
• Maintain and demonstrates knowledge of the drug development process from development through commercial manufacturing including regulatory requirements and guidelines.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.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.

INDSCIC