Manager MSAT and EM
Manager MSAT and EM
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
The Manager MSAT and External Manufacturing is a Manufacturing Operations cell therapy subject matter expert that will actively collaborate with Quality Regulatory Manufacturing Operations Process Development and our Contract Manufacturing Organizations (CMO). The Manager MSAT and External Manufacturing will lead a team of MSAT Specialists providing support and oversight of internal and external manufacturing of Iovance therapies. The position is responsible for the transfer and implementation of projects processes and technology from process development to manufacturing sites for Iovance cell therapy products.
This position will assist the Senior Director of MSAT and External Manufacturing in planning coordinating and overseeing manufacturing and manufacturing related activities through the product life cycle which includes development stability and product validation batches across manufacturing sites. This position will support manufacturing activities at the various manufacturing sites as a PersoninPlant (PIP). The PIP will be critical in the ongoing training of manufacturing staff drive/own deviation investigations provide product quality impact assessments and assist in qualification and validation activities at the manufacturing site. The Manager MSAT and External Manufacturing will own and delegate change controls and CAPAs pertinent to manufacturing operations across multiple manufacturing sites.
Essential Functions and Responsibilities
- Leads a team of MSAT Specialists providing internal and external oversight and support of manufacturing activities.
- Effectively delegates and manages the workload across a team of MSAT specialists to meet company goals.
- Leads complex manufacturing investigations and provides product impact assessments for manufacturing deviations.
- Serves as PIP overseeing manufacturing operations at CMOs.
- Provides training to new manufacturingoperators at CMOs.
- Conducts process audits of manufacturing operations across manufacturing sites ensuring continuity and reproducibility in of Iovance cell therapy processes.
- Drives complex change controls and tech transfers at manufacturing sites.
- Own Stage 2 (PPQ) of Process Validation and assist in the development implementation and maintenance of Stage 3 (CPV).
- Utilizes technical writing strategies to ensure change control content is clear concise and complete.
- Ensures timely progression of change controls through the various phases of the change management process.
- Ensures operational readiness for process transfers and change controls including; the facility equipment documentation and staff.
- Executes process transfers into the existing manufacturing structure including SOPs batch records work instructions and training curricula.
- Initiates revises and approves manufacturing procedures. Ensures all procedures reflect current operations. Serves as a document reviewer owner and approver as appropriate.
- Prepares for and participates in regulatory inspections.
- Utilizes strong operational excellence / lean principles business acumen qualitymindedness and exceptional communication skills to develop streamlined efficient and robust systems and to affect positive change.
- Contributes to the development of manufacturing strategies for resolving complex issues related to new process transfers to manufacturing sites.
- Authors reviews and approves risk assessments protocols manufacturing batch records and supporting documentation for regulatory submissions.
Required Education Skills and Knowledge
- Bachelors in relevant discipline plus 6 years of related industry experience
- Must possess a thorough understanding of cell therapy manufacturing.
- Must be able to translate biotech processing into documentation such as batch records protocols and SOPs.
- Must possess strong verbal and written communication skills.
- Ability to prepare high quality presentations and speak present data and defend approaches in front of audiences including management or inspectors.
- Technical writing must be at an advanced level with proficient spelling grammar and typing skills. Ability to understand and teach technical writing skills and minimize risk of misinterpretation.
- Exhibits leadership behaviors including collaborating for results and developing/executing strategy.
- Strong ability to influence in a team environment and collaborate with peers.
- Must be able to create an environment that encourages continuous improvement best practices and appropriate risk taking.
- Must have experience working in various Quality Systems understanding of facility technology system troubleshooting CAPAs and change controls.
- Ability to perform gowning activities and enter the manufacturing plant.
- Project Management experience with prior experience managing multiple assignments and processes while developing practical and thorough solutions for complex issues.
- Ability to meet objectives and perform with a high degree of accuracy. Expert in Microsoft Office programs
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
- 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
Key Skills
- Compliance Management
- Administrative Functions
- Oversight
- Administrative Activities
- Administrative Tasks
- Budget Preparation
- Facilities Management
- Daily Operations
- Account Management
- General Ledger Accounts
- Personnel Files
- Administrative Management
- Financial Statements
- Administrative Operations
- Annual Budget
