Senior MSAT Specialist - 2nd Shift
Senior MSAT Specialist - 2nd Shift
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1 Vacancy
Job Description
Overview
The Senior MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Senior Specialist reports to the Director MSAT and is responsible for manufacturing data analysis contributing to deviation root cause analysis and owning steps of the manufacturing process tech transfer. The Senior MSAT Specialist is also responsible for protocol and report authoring technical oversight of manufacturing operation and of MSAT laboratory activities.
Shift: Monday to Friday from 3:00pm 11:30pm
Essential Functions and Responsibilities
- Serve as a manufacturing processes technical SME representing MSAT during cross functional meetings.
- Serve as primary MSAT POC for study clinical and commercial manufacturing escalations for multiple cell and gene therapy GMP Processes. Perform PersonInPlant (PIP) responsibilities at CMOs managing production at external manufacturing facilities. Ensure alignment of manufacturing practices at all manufacturing facilities.
- Provide MSAT oversight training and support within the manufacturing cleanroom environment as well as assist with onboard training of new MSAT specialists.
- Manage and own Technology Transfer campaigns of new product introduction and process improvements to internal and external manufacturing facilities. Provide handson manufacturing process training to manufacturing personnel as part of process tech transfer as needed.
- Senior MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation:
- Quality Systems Change Control (tech transfer process improvement emergency etc. Deviations (complex manufacturing investigations) CAPAs (complete ownership) Action Items (management and
- Study or investigational protocols and corresponding reports
- Process Characterization Validation Qualification protocols and reports
- Product Impact and Risk Assessments Failure Modes Risk Analysis
- SOPs COPs MSAT MBRs
- Senior Specialists will be responsible for managing MSAT department Quality System metrics and managing complex investigations (CAPA Deviation etc. related to the manufacturing process. Investigation activities may include of studies GEMBA Kaizen Risk Analysis etc. through to completion.
- Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Will assist manufacturing and quality when authoring Master Batch Records and implementing process improvements.
- Analyze and interpret manufacturing process data and ensure process trends are addressed appropriately. Emphasize operational excellence and continuously identify process improvements i.e. efficiencies within the manufacturing operations environment.
- Execute hands on experiments in the MSAT lab (as applicable).
- Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
- Comply with Safety SOPs SDS sheets and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Required Education Skills and Knowledge
- B.S degree in a relevant discipline or equivalent industry experience.
- A minimum of 5 years of relevant handson operations experience for clinical or commercial production and/or process development experience in the life sciences industry.
- Expertise in cell culture and aseptic technique.
- Knowledge and understanding of GMP systems within a manufacturing facility.
- Ability to organize analyze manufacturing process data and provide potential process improvements.
- Knowledge and expertise in manufacturing process tech transfer. Involvement in prior manufacturing process tech transfer is required.
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to work cross functionally within the organization as part of a project team.
- Selfmotivated and willing to accept temporary responsibilities outside of initial job description.
- Must be comfortable in a fastpaced small company environment and able to adjust workload based upon changing priorities.
Preferred Education Skills and Knowledge
- Prior cell therapy experience is highly preferred.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)
- Must be able to move to and from the office to the lab located on separate floors and move about the office and lab as needed.
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to grasp with both hands perform repetitious actions such as pinch with thumb and forefinger turn with hand/ arm and reach above shoulder height.
- Must be able to use several types of laboratory equipment and pipettes for extended periods.
- Must be able to work on a tablet or computer typing for 50 of a typical working day.
- Must be able to move and lift 20 pounds multiple times daily.
- Must be able to use near vision to view samples at close range.
- Wear proper personal protective equipment when in a laboratory setting i.e. safety glasses lab coats and closedtoed shoes.
Mental: Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
Work Environment
This position will work in both an office and a laboratory setting. When in the lab there may be a risk of exposure to hazardous or biological waste within the environment through receipt transport storage preparation dispensing administration cleaning and/or disposal of contaminated areas and waste.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equalopportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact .
By voluntarily providing information and clicking Submit Application you explicitly consent to the collection and use of your personal information for the purposes described above and in ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Full-Time
