Analytical Scientist III

SKpharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California, Texas, and Virginia specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities. We are looking for enthusiastic Scientists to join our Analytical Teams! We have opportunities at our Rancho Cordova, CA - (Greater Sacramento, CA) area location. Benefits and 401k enrollments starts the first of the month following date of hire.

Job Summary:

In this role you will apply your expertise in a range of small and large molecule analytical techniques to provide technical design, leadership and execution of method development and validation activities for various drug substances and drug products. As an Analytical Scientist III, you will ensure analytical tasks and methods are suitably qualified/validated for use in GxP laboratories, support filing activities, as well as being heavily involved in the company's overall commercial strategy.

Job Responsibilities:

• Method implementation for raw materials, in-process, final product, and stability samples for the pharmaceutical industry. Development of analytical techniques able to accurately quantify and/or identify various purities and impurities related to a certain drug substance and/or drug product.

• Research and development of analytical techniques related to manufacturing of drug substances or intermediates in various stages (R&D, pilot, and plant scale). Compiles data obtained from analytical tests, analyze the data, and report the final result to appropriate department.

• Perform training in techniques and/or computer systems used for analysis of pharmaceutical chemicals to newer or lower level scientists.

• May perform general housekeeping including maintaining general cleanliness of laboratories and restocking reagents and laboratory consumables.

• Provide imaginative, thorough, and practicable solutions to a wide range of technical problems involving the conventional utilization of chemical analysis techniques

Educational Requirements:

• PhD, Master's or Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences or related science degree required.

Experience Requirements:

• PhD (2+years), MS degree (5+years), BS degree (8+years) in a GxP biopharmaceutical environment, primarily focused on analytical method development and validation. The successful candidate will have in-depth knowledge and experience of a range of analytical techniques (LC-MS/MS, immunoassay, flow cytometry & qPCR) acquired in pharma or CRO/CMO industries. Experience with gene therapy & oncology programs is a plus.

• Experience in mass spectrometry, including ESI,EI, and MALDI ionization with a range of mass spectrometer designs (Q-TOF, Orbitrap, QQQ etc.), and standard chromatographic techniques (HPLC/UHPLC/IEC) and detectors.

• Experience in method development, optimization, and validation for pharmaceuticals

• Strong background in GxP laboratory environment and regulations

• The successful candidate will have in-depth knowledge and experience of a range of analytical techniques acquired in pharma or CRO/CMO industries for small molecules. Experience with other platforms including oligonucelotides, peptides and gene therapy is advantageous.

• Good judgement and an understanding of chemistry theories and concepts.

• Must have a high consciousness for personal and laboratory safety.

• Strong attention to detail.

• Strong interpersonal and verbal communication skills.

• Team oriented.

This position may be filled at a higher or lower level, based upon the candidates experience per the Company's Job Families.

SKPT is an Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender expression or identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics, both state and federal.