28 days old

Sr. Director Cell Therapy Process Development

Kelly Services
Rockville, MD 20851
**Job Title:** Senior Director Cell Therapy Process Development

**Location** : Rockville, MD

Client is a privately held and clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapies. This platform is designed to utilize the bodys natural biochemistry to develop vaccines that have the potential to generate broad immune responses and have applications in a number of therapeutic areas (infectious diseases, oncology, allergy, and autoimmune diseases).

The Senior Director will be responsible for overseeing the development of manufacturing processes of cell therapy products. This position requires a highly motivated candidate with good laboratory skills, who will work on process development initiatives, process characterization, data recording, management of process technical documents, and technology transfer activities to GMP manufacturing. Prior experience in cell therapy process automation technologies will be preferred. The successful candidate will have competency in the application of statistical methods, tools for data analysis, writing technical reports, and data presentation in internal and external meetings. The candidate will report to VP Cell Therapy.

**Essential Functions:**

+ Support the establishment of the Process Development Laboratory, including identification, evaluation, and installation of equipment.

+ Design and execute process automation and support tech transfer of processes to GMP manufacturing.

+ Critically analyze data from processes and author technical reports and standard operating procedures.

+ Summarize and present data in group meetings and contribute to group discussions.

+ Drive continuous improvement activities. Evaluate new technologies and innovate novel approaches to improve existing methods.

+ Author and review technical and regulatory documents in support of CMC regulatory submissions (IND, BLA, etc.).

+ Engage with both internal and external partners in the support of Process Development, preclinical, and clinical development of cell and gene therapies.

+ Will interact directly with R&D, Quality, Regulatory Affairs and Project Management as an integral part of the product development team.

+ Will interact with external organizations (e.g., Contract Manufacturing, Contract Testing, Contract Development, Equipment vendors)

+ Will have direct supervisory responsibilities.

**Required Education and Experience** :

+ Ph.D. in appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 7-10 years of work experience in cell therapy.

+ Understanding of immunology and cellular biology with application to development of cellular processing methods.

+ Experience and competency with the cell therapy process automation technologies such as Sepax, Lovo, CliniMACS, Prodigy.

+ Experience using transfection techniques.

+ Experience working with human immune cells is preferable.

+ Competency in the application of statistical methods and tools for data analysis.

+ Ability to work independently or as a team member to meet goals and commitments.

+ Strong written and verbal communication skills are required.

+ Experience translating complex scientific concepts and data into reports, presentations and CMC filings is required.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-09-07 Expires: 2022-10-08

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Sr. Director Cell Therapy Process Development

Kelly Services
Rockville, MD 20851

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