Singota Solutions

Support the technical operations department as a subject matter expert, technical transfer liaison and technical writer on parenteral drug product manufacturing projects.. Author Batch Records and Specification sheets for Formulation, Filling, Inspection and Finishing.. Bachelor's degree in a scientific discipline and 7+ years' experience in pharma industry, formulation and aseptic manufacturing experience preferred. Associates degree in a scientific discipline and 10+ years' experience in a pharma industry, formulation and aseptic manufacturing experience required.. If you need accommodation for any part of the employment process because of a disability, please send an e-mail to mcguire.bahr@singota.com or call 812-369-9770 to let us know the nature of your request.

manufacturing

Job Description JD245 Job title: Manufacturing Sciences & Technology, Scientist/Engineer 3 Department: Operations Reports to: Technical Operations Manager Location: Bloomington, IN (Onsite) Position Type: Full-time, 40 hours/week, 1st shift, Exempt General Responsibilities: <ul><li>Support the technical operations department as a subject matter expert, technical transfer liaison and technical writer on parenteral drug product manufacturing projects.</li><li>Serve as Manufacturing SME on client project teams.</li><li>Stays current with bodies of knowledge, identifying best practices, regulatory requirements, industry standards and trends.</li><li>Share knowledge gained with Singota employees.</li><li>Identify process improvements, support planning and implementation, and track metrics.</li><li>Author, edit, review, and execute procedures and protocols.</li><li>Author Batch Records and Specification sheets for Formulation, Filling, Inspection and Finishing.</li><li>Collaborate in writing and responding to deviations, investigations, and corrective actions.</li><li>Maintains knowledge of and performs functions in compliance with laws and regulations including but not limited to Company's policies and standard operating procedures, FDA and similar regulatory authorities.</li><li>Positive Attitude and willingness to work as part of a diverse team to achieve overall goals of the company.</li><li>Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures. Ensure procedures are followed and changed if no longer applicable.</li><li>General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.</li><li>Aids with regulatory support to review and/or author regulatory documents.</li><li>Operational knowledge of Cytiva/Vanrx SA25 or other robotic filling isolator is a plus.</li></ul> Skills and Physical Activity Requirements: <ul><li>Able to support the client team as a subject matter, in organizing and leading meetings, and driving projects to meet operational deliverables.</li><li>Proficient with electronic systems, including but not limited to enterprise resource planning (ERP), and Microsoft Office applications, particularly Word, Excel, PowerPoint and Project.</li><li>Trustworthiness and personal integrity - able to maintain a high degree of confidentiality</li><li>Strong verbal, listening and written communication skills.</li><li>Good time management and organizational skills.</li><li>Positive attitude and good judgment.</li><li>Customer focused both to internal staff and external clients.</li><li>Proficient math and chemistry skills required including knowledge of manufacturing methods.</li></ul> Requirements Education Requirements: <ul><li>Bachelor's degree in a scientific discipline and 7+ years' experience in pharma industry, formulation and aseptic manufacturing experience preferred</li><li>Or</li><li>Associates degree in a scientific discipline and 10+ years' experience in a pharma industry, formulation and aseptic manufacturing experience required.</li></ul> Benefits <ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Retirement plan</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul> Singota Solutions is an Equal Opportunity Employer Singota is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a disability, please send an e-mail to mcguire.bahr@singota.com or call 812-369-9770 to let us know the nature of your request. Thank you for visiting EMPLOYMENT OPPORTUNITIES at Singota Solutions! Below is a link to the voluntary self-identification forms used by Singota Solutions only to collect and maintain records required of employers doing business with the federal government. YOU DO NOT HAVE TO ANSWER THESE QUESTIONS TO BE CONSIDERED FOR EMPLOYMENT WITH Singota Solutions. If you do choose to answer these questions, any information supplied by you on this voluntary self-identification form will not affect your employment opportunities with Singota Solutions, which is an equal employment opportunity employer. If you choose to complete the forms, please return via email to employment@singota.com Voluntary Self-Identification Form If we need additional information or want to schedule an interview, we will contact you. If your qualifications do not match our current needs, we will keep your resume and/or application on file for one year. Thank you for your interest in Singota Solutions!

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