Senior Bioprocess Scientist
South Miami, FL
Position: Senior Bioprocess Scientist
Location: Miami, FL (Onsite – 40 hours a week)
Length: 6 months (Contract to Hire)
Covid Requirements: N/A
Our client is looking for an experienced Senior Bioprocess Scientist to collaborate with cross-functional teams, to participate in the development and production of novel research use and cGMP grade cell and cell-based materials for cell therapies. The Senior Bioprocess Scientist will ensure that products will be developed and manufactured under GLP and GMP practices, participate in tech transfer from Process and Product Development (PPD) to manufacturing and customers, and support the manufacturing program and Business Development team with technical support.
Essential Duties and Responsibilities:
- Deliver on scientific goals in support of corporate objectives, under the direction of the management team.
- Lead the development and optimization of robust and scalable processes for product manufacture (including multiple adherent and non-adherent cell types) using 3D bioreactors of various scale and progressing from research to commercial-scale bioreactors.
- Lead the development and characterization of novel products that include extracellular vesicles, using translation-ready and scalable production systems.
- Contribute to the development of new, custom, or existing products, with reasonable cost of goods and according to established project timelines.
- Contribute to Scopes of Work and project execution for partner programs.
- Work independently and with a level of functional expertise necessary to influence and execute product technical development.
- Participate in the design and lead the assessment of critical process parameters, including process and product characterization utilizing methods that include but are not limited to, FLOW analysis, ELISA and ELISA-based methods, multi-plex assays, histological assays, etc.
- Collaborate with Quality Control to establish appropriate Critical to Quality (CTQ) metrics and validated assessment methods.
- Analyze accumulated data to streamline process and product development and consistently report out to management team.
- Write and review technical reports and Standard Operating Procedures.
- Manage technology transfer from PPD to manufacturing and lead manufacturing in troubleshooting production issues with standard and specialized products.
- Serve as a subject matter expert and liaison to process development, Manufacturing Science and Technology (MSAT), manufacturing, and business development.
- Supervise and coach scientists and cell processing specialists and help manage routine team operations.
- Work closely with other functional teams in a matrix organization to move projects forward.
- Provide regular production status updates to PD, MSAT, and Manufacturing teams.
- Support external audits and inspections, as required.
- Support daily laboratory operations including cleaning, maintenance, ordering, and inventory management.
- Master’s degree in Bioengineering, Chemical Engineering, Biological, or related scientific field with 5+ years of experience, or 7+ experience in an applicable field.
- Extensive cell culture experience is required.
- Minimum of 5 years of experience in process development and/or GLP/GMP manufacturing of cell and gene therapy products.
- Basic understanding of cell biology, immunology, bioprocess, and engineering principles.
- Minimum of 2 years of experience with primary cell isolation and aseptic techniques.
- Well-honed analytical skills and knowledge of statistical software to conduct data analysis.
- Strong experience in upstream and downstream cell processing and culture technologies in support of the finished materials production.
- Ability to apply scientific and engineering approaches to problem solving and process development.
- Experience in process optimization, process characterization, process and product validation, equipment validation, and SOP authoring.
- Ability to quantify experimental results and relay findings to internal and external teams.
- Robust oral and written communication skills.
- Outstanding interpersonal and conflict resolution skills.
- Extreme attention to detail and thorough record-keeping.
- Excellent organizational and time-management skills with the ability to manage multiple concurrent projects.
- Ability to work independently and collaboratively in a fast-paced and dynamic environment.
- Productive and solution-oriented work ethic.
- Experience with birth tissue-derived cells (MSCs, HSCs, and immune cells) is a plus.
- Experience in a GLP and/or GMP manufacturing setting is a plus.
- Bioreactor process development experience is a plus
- Weekend and late hours may be required at times.
- Ability to have a flexible mindset as this position will initially report into PD, but responsibilities and position within the organization will evolve as the organization grows.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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