The Scientist role is a technical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in designing and conducting experiments at the laboratory bench, analyzing data, and interpreting results in molecular biology methods. This role will perform hands-on laboratory experiments in support of QC analytical methods.
Duties/Responsibilities
- Provide molecular biology analytical expertise in support of QC lab investigations and method optimizations. This encompasses supporting technical investigations to identify root cause and provide corrective and preventive actions, including method remediations and experimental studies at the bench.
- In accordance with established protocols and research objectives, independently execute experimental work with a high degree of technical proficiency, contribute to data analysis and documentation, and collaborate within cross-functional teams. Contribute to the development and optimization of new and existing laboratory methods and protocols.
- Present experimental findings and progress updates to immediate team. Support the preparation of internal technical reports and presentations as appropriate.
- Support transfer of commercial methods and method validation in compliance with global regulatory requirements.
- Responsible for the stewardship of molecular methods in the Cell Therapy Quality organization.
- Implement method lifecycle and method maintenance programs to support molecular biology methods in support of cell therapy drug products.
- Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.
- May lead project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.
- May provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and functioning as the method validation and method transfer expert during inspections as required
- May partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
- Perform other tasks as assigned.
Reporting Relationship
- This position will report to Cell Therapy Global Quality Analytical Sciences and Technology (ASAT) management.
Qualifications
- Bachelor?s degree in relevant scientific discipline or equivalent is required. Advanced degree preferred.
- 6 years of relevant analytical experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy.
- Strong scientific background and expertise, encompassing various cell-therapy relevant methodologies. Molecular Biology: Molecular methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms. Specifically expertise in DNA extraction and qPCR.
- Hands-on laboratory experience and demonstrated proficiency with standard laboratory techniques relevant to the role.
- Experience in analytical method lifecycle including method transfer, validation, critical reagents and maintenance. Experience providing training in method execution as well as instrument operation and standardization.
- Experience in cGMP regulations and application within the Quality Control environment.
- Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell therapies, vaccines and/or biological products.
- Must possess effective time management skills, demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team.
- Strong technical writing skills are required (SOPs, Method Validation Protocols and Reports).
- Ability to communicate effectively with peers, department management, cross-functional peers and to work collaboratively in a team-oriented setting.
- Ability to travel to other BMS sites or Partner sites is required.
Onsite/Hybrid- 100% Onsite
Work Schedule- M-F; Standard Hours!
This posting is for a contract assignment with
ASK Staffing DBA ASK Consulting to provide services to
Bristol Myer-Squibb.
The starting hourly compensation for this assignment is the following range ($50- $52.45/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.
About ASK Consulting
ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.
Benefits
ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.
Equal Opportunity Employer
ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.
California Applicant Notice
ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contactingHR@askconsulting.com.
Fair Chance Employment Notice
If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.
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This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration.
