Biochemist

Job Description

Responsibilities (include but are not limited to):

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.

• Work with internal and external resources to maintain lab in an optimal state.

• Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.

• Maintains laboratory instruments for calibration and routine maintenance

• Author or revise SOPs, qualification/validation protocols and reports.

• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.

• Provide updates at daily and weekly meetings.

• Monitor the GMP systems currently in place to ensure compliance with documented policies.

Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.

• Gather metric information for use in continuous improvement of areas of responsibility.

• Perform other duties as required.

Basic Qualifications:

• Bachelor’s Degree OR

• AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR

• High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience

Preferred Qualifications:

• Strong knowledge of GMP, SOPs and quality control processes.

• Identifying, writing, evaluating, and closing OOS’s and investigations.

• Proficient in MS Word, Excel, Power Point and other applications.

• Strong written and verbal communication skills.

• Ability to communicate and work independently with scientific/technical personnel.

• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.

• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

• Preferred: Experience in the biotech and/or pharmaceutical industry.