Sanaria is currently expanding its activities and is accepting inquiries and resumes for the positions listed below. If you are interested in furthering your career with us please send the following information to firstname.lastname@example.org:
Sanaria is an equal opportunity employer.
AVAILABLE POSITIONS: Medical Writer Quality Engineer Assistant Controller Research Associate - Mosquito Production Team
Sanaria is now embarking on an ambitious program designed to lead to licensure, and will be conducting clinical trials at multiple sites in Africa, Europe, and the United States. Sanaria is currently recruiting for a Medical Writer experienced with Clinical Protocols, Amendments, Reports, and Manuscripts, ideally with background in vaccine (or drug) development.
The Quality Engineer will work closely with Facilities and Manufacturing departments to review, approve and support utility and equipment deviations, validation studies, change controls, work orders and calibration. The Quality Engineer will ensure that testing performed is consistent with approved protocols, policies, guidelines and SOPs. The incumbent will write, review, analyze and revise written SOPs and submit procedural changes necessary to meet regulatory requirements. The Quality Engineer will also schedule, oversee and approve contractors' work on equipment calibrations, preventive maintenance, cleaning of cleanrooms and laboratories, and repairs. The Engineer will create Quality documents and reports including protocols, qualifications, and regulatory submissions. This position will support the manufacturing process with timely closure of observations/audit items.
Qualified candidates must have a BA/BS degree in engineering or science (chemistry, biology preferred) with 2-5 years of relevant experience in a GMP manufacturing environment. The successful candidate will have a good understanding of the Code of Federal Regulations, GxPs, FDA regulations governing validated applications including (21 CFR Parts 11, 210, 211, 820). Experience in equipment, utilities, computer systems, and facility validations is essential. The position also requires excellent communications skills and demonstrated experience writing SOPs and validation protocols. U.S. citizenship or permanent eligibility to work legally in the U.S. is required.
Reporting to the Vice President, Administration, the Assistant Controller will maintain compliant records of all grants, contracts, sales and support agreements; track receipt and disbursement of funds in accordance with GAAP and agreement terms; monitor revenue and expenditures against approved budgets; support budget development and the grants and contracts application process; analyze the company financial position and present reports to management; and prepare required external financial reports.
The Assistant Controller will support the VP of Administration, CEO, General Counsel and Executive team by tracking and analyzing companies' financial performance against the annual budgets and short and long-term business strategies as developed by management. The incumbent will also maintain compliant policies and procedures and assist with external audits.
Qualified candidates must have a BA/BS degree in accounting or business, with 3-5 years of experience, including experience in an accounting or finance position with full responsibility for day-to-day financial transactions, accounts payable/receivable, GL entries and monthly close. Strong experience in budget development, monitoring of revenue and expense against budgets, financial analysis and development of advanced financial reports.
Strong grants and/or contracts management experience, including grant proposal submission and reporting processes, and expense allocations across multiple simultaneous grants or contracts. Experience with external audit process and responding to auditor data requests. Strong collaboration and communication skills.
Excellent computer-based analytical skills, knowledge of accounting and financial management systems and expert Quick Books and Excel user.
Research Associate - Mosquito Production Team
The Research Associate will perform key operations during manufacture of Sanaria's PfSPZ Vaccine and other products that may include mosquito production; mosquito dissection; formulation, revision and development of SOPs and batch records for the aseptic mosquito production and vaccine manufacture; review of batch records; monitoring the sporogonic development of the malaria parasites in mosquitoes; transfer of aseptic mosquitoes for vaccine manufacture, oocyst assessments vialing or cryopreservation of final product, or other component procedures. The Research Associate will also work on in vitro production of sporozoites, quantifying transmission blocking activity using fluorescent microscopy and standard membrane feeding assays.
Qualified candidates must have a Bachelor's or Master's degree in Biology or a related scientific field with some practical experience in sterile technique, microscopy, and cell/tissue culture. Experience with GMP manufacturing is a plus. The successful candidate must have excellent communication, writing, team work and organization skills. Flexibility and the willingness to learn new experimental and operational techniques are essential. U.S. citizenship or permanent eligibility to work legally in the U.S. is required.
copyright(c) 2003-2015, Sanaria Inc., all rights reserved