Specialist II, Biomanufacturing

Position Summary & Role This position will prepare cGMP manufacturing documentations (e.g. process batch records, Bill of Materials, sampling plans, label specifications, standard operating procedures, etc.) for the Manufacturing Department at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida). Essential Position Responsibilities: Serve as a partner to PD and MS&T in the successful development of process manufacturing batch records and bill of materials based on the tech transfer protocol Training manufacturing operators on batch records Draft Standard Operation Procedures, Work Instructions, Change Controls, and Deviations, and other controlled documentation as needed Assist in critical manufacturing deviations Adhere to safe working practices *All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role Preferred Educational Requirements for Competency: (Please attach the copy of any degree, certificate, training as necessary) Bachelor’s level degree in Chemistry, Biochemistry, or Biotechnology with a minimum of 3 years of manufacturing, engineering, or laboratory work experience, an A.S (Science or Engineering) and a minimum of six years of manufacturing, engineering, or lab work experience, or a combination of education and work experience that aligns Experience in upstream, downstream, fill finished, packaging and labeling operations, process/tech transfer to internal and/or external GMP manufacturing organizations Experience in developing manufacturing batch records and standard operating procedures Excellent technical writing skills Experience in writing deviations, investigations, and change controls. Must have intermediate to advanced computer skills and be proficient with Word and Excel. Previous work experience in a GMP environment Self-motivated and hard working Detailed-oriented Physical Demands: Sedentary work- Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary wok involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Light work- Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work. Medium work- Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Heavy work- Exerting up to 100 pounds of force occasionally, and/or up to 50 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects. Very heavy work- Exerting more than 100 pounds of force occasionally, and/or more than 50 pounds of force frequently, and/or excess of 20 pounds of force constantly to move objects. This job requires the employee to perform the following physical activities: Climbing Balancing Use of fingers Stooping Kneeling Repetitive motion Crouching Crawling Feeling Reaching Standing Grasping Walking Pushing Hearing Pulling Lifting Talking Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $33.00 - $41.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites

Salary : $33 - $42