Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative,
Intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.
Job Duties/Responsibilities
- Learn and execute Cell Therapy Manufacturing operations compliantly
- Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)
- Executes transactions and process in all electronic systems and adheres to business continuity processes
- Prioritizes safety of self and others
- Reports safety events within 24 hours
- Immediately escalates any/all issues that may impact compliance or safety of self and/or others.
- Complete documentation required by Source Governing Documents contemporaneously
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA
- Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge.
- Train for proficiency in process systems and some supporting business systems
- Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts
- Work within a control cleanroom environment and execute aseptic processing procedures (as assigned)
- Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications)
- by performing area disinfection regiment as required to meet global Health Authority requirements
- Continues to refine and improve manufacturing process technique to improve individual operational times.
- Verifies training completion prior to performing any GxP tasks
- Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements
Qualification: Education:
- Associate or bachelor's degree in related field is preferred; Life science degree (Biology, Chemistry, and Environmental) or someone with experienced in controlled industries like Pharma, Biotech, or Food Science.
Experience
- years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
- Proven experience working on teams where collaboration and results were expected.
- Proficiency in common computer tools such as word processing, spreadsheet and web-based applications
- Meticulous attention to detail and personal accountability is critical to success
- Possess excellent interpersonal skills, is attentive and approachable
- Maintain a professional and productive relationship with area management and co-workers
- Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred
Top Skills
- Bachelor's degree in Life Sciences Degree is preferred
- Experience in regulatory controlled environments
Working Conditions
- Must be able to stand/walk for extended periods of time.
- Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
- Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
- Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
- Work in areas that may have strong magnets
- Must be able to work in a BSL2 / ML1 work environment handling human blood components
- Work in areas with exposure to vapor phase liquid nitrogen
- Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)
100% Onsite
Schedule: Shift Timing- This will be 12-hour shifts: Sun, Mon, Tues, and alternate Wednesdays. 5:00am ? 5:30pm.
Number of Positions- 1
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 ($18- $21.95/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.
To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice andCCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.
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.
