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Research Associate - III*
Location:
Vista, CA
Description:
Innova Solutions is immediately hiring Research Associate - III . Position type: Fulltime - Contract Duration: 6 Months Location: Oceanside, CA As Research Associate - III , you will: Job Description: Role: Senior Research Associate - Biologics Drug Product Development (BDPD). BDPD is responsible to develop and characterize formulations and processes for all biologic drug products in pivotal (P3) and commercial stages; also responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use and compatibility to support clinical studies.Seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics. Essential Duties and Job Functions: Perform experiments pertaining to: o Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods o Scale-down/-up of biologics drug product processes o In-use stability and administration Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites Be an effective communicator of ideas, project goals and results at departments/meetings in both written and presentation format. Be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature. Knowledge, Experience and Skills: Degree in Chemical/Biochemical Engineering (or a related engineering discipline) or Pharmaceutical Sciences, and relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals. Excellent communication (both verbal and technical) and interpersonal skills are required. Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy. Minimum Qualifications: A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline. A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc.). Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus. Must Have Requirements/Skills: Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) and UF/DF is a plus Nice to Have Requirements/Skills Presentation and Documentations (ELNs, technical reports, MEMO, etc) good understanding / experience in biologics drug product process (freeze-thaw, filtration, mixing, filling, lyophilization) some understanding of in-use stability and drug administration process and associated challenges (IV bags, subcutaneous injections) Thank you! Pradip Joshi Senior Associate, Recruitment Phone: 213-401-XXXX PAY RANGE AND BENEFITS: Pay Range*: $45-$46/Hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-XXXX. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. * 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.PDN-9c35f1aa-b0d5-48bc-ab01-a6349d22ef2c
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