Manufacturing Sciences Expert
6 days ago
We are seeking an experienced Manufacturing Sciences Expert to join our team at Akron Biotechnology, LLC. This role will focus on the development and implementation of upstream and downstream processes at our manufacturing site. The successful candidate will lead the development and execution of cGMP activities in collaboration with Process Development and Manufacturing departments.
Main Responsibilities:
1. Develop and maintain business processes for technology transfer from clients to Akron Biotechnology, LLC and from process development to cGMP manufacturing.
2. Oversee the introduction of new production processes using proper technology transfer approach, perform risk assessments, and analyze new project introduction and existing campaign risks and gaps.
3. Lead the implementation of new processes in process development laboratories and evaluate process maturity for transfer into cGMP production.
4. Collaborate with process development scientist and manufacturing engineers to develop and implement upstream and downstream process development experiments.
5. Troubleshoot Upstream and downstream processes as needed in collaboration with process development scientist and manufacturing engineers.
6. Develop new processes using cGMP compliant raw materials in collaboration with Quality Assurance department.
7. Lead readiness activities for unit operations such as bacteria thaw and incubation, fermentation, centrifugations, depth filtrations, diafiltration/ultrafiltration, chromatography, formulations, cell banking, final fill, aseptic manipulations, etc. and execute at the production floor.
8. Develop, review, and approve Manufacturing Batch Records.
9. Review and approve SOPs and Work Instructions (WI) and Batch records.
10. Review and approve Bill Of Materials (BOM) and BOM templates, and Bill Of Equipment (BOE).
11. Develop Process Performance Qualification (PPQ) and Process Validation guidelines and oversee activities as needed.
12. Own deviation investigations and implementation of change controls, CAPAs, and other QMS-activities.
13. Provide subject matter expert input to support continuous improvement, capital, and corporate initiatives.
14. Responsible for compiling and analyzing trend data, preparing reports, and making recommendations for changes and/or improvements.
Requirements:
1. MS or BS in Biology, Chemistry, Bioengineering, or a related field with at least 5 years' experience working in a life science process development or manufacturing role (biopharmaceutical fermentations and purifications).
2. Must have demonstrated biologics expertise in upstream or downstream processing and operations and have strong knowledge of industry best practices.
3. Expertise with technical transfer and scale up required.
4. Experience with single use technology applicable to technologies such as: fermentation, filtration, chromatography, etc.
5. Prior experience in cGMP manufacturing, operation of process equipment, and aseptic technique required.
6. Proven technical expertise in upstream or downstream biologics required.
7. Data analytics experience with JMP or similar program preferred.
8. Detail-oriented with good time management and organizational skills, ability to prioritize assignments in a multi-task position required.
9. Motivated and able to work both independently and as part of a growing manufacturing team.
10. Excellent verbal communication skills required.
11. Ability to work a flexible schedule in a biomanufacturing environment required.
12. Execute tasks in a timely manner without direct supervision.
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