Manager Analytical Development Cell Therapy
Manager Analytical Development Cell Therapy
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Job Description
Overview
The Manager Analytical Development will lead projects at CTLs/CDMOs that focus on the development qualification validation verification and comparability of analytical assays and processes for early to late phase clinical products as well as for commercial final drug product (DP) supply. This position will support cellular manufacturing process development and optimization product characterization analytical development technology transfer activities as well as release and stability testing for Tumor Infiltrating Lymphocyte (TIL) products used in clinical trials for the treatment of solid tumors sponsored by Iovance Biotherapeutics.Experience in developing CMC packages for IND /BLA /MAA submissions and other Regulatory engagements for cell and gene therapy products is required.
Essential Functions and Responsibilities
- Lead and provide scientific oversight and technical advisement for bioassays safety assays and bioanalytical studies including qualification validation verification and comparability utilizing a variety of analytical techniques and instrumentation.
- Subject matter expertise in developing and performing analytical methods and data analysis of results for various analytical methodologies including but not limited to genome integrity genotyping for allelic KO WGS NGS gene expression immunophenotyping flow cytometry replication competent lentivirus PCR based methods (Host Cell DNA vector copy number etc. protein expression ligandbinding assays (ELISA MSD etc. cellbased potency assays and cytotoxicity assays
- Expertise in safety assay testing for product release and raw material qualification including but not limited to bioburden sterility endotoxin mycoplasma and bacteriophage.
- Lead study design for analytical runs and investigations data analysis as well as culmination and presentation of data for peer review and in support of Regulatory agency submissions.
- Provide project management oversight of and demonstrate ability to troubleshoot external contracts for analytical method development and validation product release and stability testing raw material and excipient release testing critical reagent qualification and MCB/WCB qualification.
- Strong technical writing ability to author and review SOPs protocols and associated reports quality documents Regulatory submissions per Good Documentation Practices (GDP) and quality standards.
- Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars.
- Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
- Perform miscellaneous duties assigned.
Travel 10 of the time
Required Education Skills and Knowledge:
- PhD with 2 years of industry experience MS 5 years industry experience or BS with 7 years of industry experience with cell and gene therapy products with a focus in Immunology /Molecular Biology / Genetics field.
- Possess a solid understanding of verification and validation of assays supporting clinical and commercial release of drug product as well as comparability release and stability testing per appropriate regulatory guidance and standards.
- Quality control and GMP experience is required.
- Prior experience developing and supporting cell and or gene therapy drug products. Understanding of regulations and guideline documents (cGMP / ICH / USP /EP pharmacopeia) required
- Ability to apply critical thinking skills to evaluate technical requirements and effectively communicate (written and oral) findings.
- Prior experience with project management tools managing external contracts demonstrating effective communication and documentation skills tracking to timelines and milestones in scope and on budget.
- Must be capable of working in a fastpaced collaborative environment and manage multiple concurrent projects with competing priorities with a high degree of independence and agility.
- Strong interpersonal written and oral communication skills are required.
- Must be organized able to multitask and be a team player.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office andexert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures viewing a computer screen and extensive reading.
- This position requires repetitive motion substantial movements (motions) of the wrist hands and/or fingers.
- Must be able to communicate with others to exchange information.
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:
Manager
Employment Type
Full-Time
