Aptask Global Workforce (AGW) is seeking a Technical Development Scientist III for an Onsite position with a Global Biotechnology Company located in San Diego, CA. This is a contract opportunity. We are seeking an experienced and motivated Scientist III to join the Analytical Development team. This position works to develop robust analytical methods for cell product characterization and release. The successful candidate will develop and use state-of-the-art analytical methods to characterize cell therapy products and processes, critically evaluate scientific data, and act as a subject matter expert on cross-functional teams.
Responsibilities: - Develop or adapt analytical methods for cell therapy product release and characterization by designing and executing studies via design of experiment (DoE)
- Design and execute exploratory experiments to better understand and define CQAs and optimize current analytical methods
- Independently research, plan and execute experiments and analyze data to determine next course of action and make recommendations
- Perform risk and gap assessments for analytical methods and aim to enhance compliance and robustness
- Execute routine laboratory experiments in collaboration with more junior technical staff to generate high quality data
- Perform data analysis and document study outcomes and conclusions, summarize and present to key stakeholders
- Design, execute, and approve method development, transfer, and qualification in support of process development, product characterization, product release and stability
- Lead lifecycle management of analytical assays by trending the data assigning appropriate controls
- Author SOPs, assay development and qualification reports and regulatory documents
- Work with a cross-functional team to advance development of cell therapy products
- Support training of junior Research Associates or other team members, as needed
Requirements: - Masters degree with 6-9+ years experience in analytical development, QC, technology transfer and method lifecycle management or Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Molecular Biology Biochemistry, or related field) with 2+ years of industry experience
- Expertise in flow cytometry and immunology analytical method development, method transfer to QC labs is required
- Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation
- Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE)
- Ability to interpret and apply ICH guidances, cGMP, USP, regulatory requirements and industry best practices
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent interpersonal, verbal and written communication skills
- Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description
- Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams
- Ability to think critically and demonstrated troubleshooting and problem-solving skills
- Attention to safety, good laboratory practice, and good documentation practice
Desired skills: - Two plus years of relevant cell therapy industry experience
- Experience with analytical control systems for stem cell and T cell products
- Experience with one or more of the following analytical techniques: ddPCR, qPCR, cell imaging, reporter-based potency, cell engineering, Next-Generation Sequencing, and metabolic analysis
Pay range: up to $73.63 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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