Description: Job Details: Bachelors' degree & 2 YOE. As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.
Responsibilities include: 1. Monitor or follow established experimental design and protocols and perform routine tasks and studies to obtain reproducible and reliable results with limited supervision 2. Plan, monitor or conduct, analyze and records experiments, and provide interpretation of data 3. Effectively transfer experimental methods from literature to the lab and make modifications as necessary 4. Develop and implement new protocols with moderate review 5. Engage coworkers in scientific discussions 6. Communicate data and interpretation to work group 7. Effectively trouble-shoot equipment and experimental difficulties 8. Contribute to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents 9. Participate in department-wide support efforts such as safety, recruiting and committees 10. Coordinate and organizes resources needed to complete the task.
Day to Day Responsibilities: • Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations • Develop solutions to technical problems during process characterization and aseptic manufacturing • Support one or more clinical and commercial process introductions or process transfers into manufacturing network • Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions • Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements • Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
Skills: Firm knowledge of Engineering and Scientific concepts Communications and writing skills Biopharmaceutical experience Willingness to learn
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.
