Senior research associate, research and development job description

A client of Sharp Decisions Inc. is looking to bring on a Senior Research Associate to be based in Santa Monica, CA.

The candidate will be assisting in deep analytical characterization of cell therapy product. You will also be assisting in planning and executing laboratory studies, analyze experimental data and carefully document resultant information. You will participate in laboratory activities to support analytical and process development as well as the characterization of Kites T cell products.

* Support process analytical testing and execute cell based assays to advance process and product understanding of cell therapy products Assist in data verification to ensure data integrity

* Perform data analysis, data reporting, and further statistical analysis with advanced analysis software
* Maintain, calibrate and operate analytical equipment
* Assist in developing standard operating procedures and analytical test methods
* Write, review and edit accurate technical documents
* Provide user training on instruments, sample analysis, and cross-train analysts on analytical methods
* Coordinates activities for members of project teams in the initiation and execution of laboratory experimentation
* Other duties as assigned

Qualifications

Bachelors degree in biotechnology or related field required (or relevant experience) with 2+ years of experience in similar role in a laboratory, preferably at least 1 year of lab experience within the industry

This position requires at least 1 year of experience with aseptic technique, cell culture, PCR, and ELISA Experience with other techniques in molecular biology is a plus Experience with other immunoassay technologies such as MSD or Luminex is a plus Previous experience with cell therapy products is a plus

Ability to follow laboratory procedures with attention to detail and successfully execute experiments at the bench. Ability to think critically and demonstrate troubleshooting and problem solving skills Strong organizational and record keeping skills Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description While most of the schedule will be during a standard work-week, occasional weekend work will be required Excellent interpersonal, verbal, and written communication skills Excellent skill in Microsoft Word, Excel, and data analysis

The Senior Research Associate will report to the Scientist II, Drug Product Development. The position will focus mainly on internal development and support external activities for performing sterile injectable drug product development activities for Sarepta's Gene Therapy, PMO, and PPMO programs. This position will work closely with Drug Product Operations, QA/QC, and Process Development teams to support ongoing and new programs within the Sarepta pipeline.
Primary Responsibilities Include:
Performs product characterization and formulation development experiments internally and supports external contract testing laboratories for development and scale-down activities throughout the drug product development process Experience with AAV gene therapy products, sterile injectables, and particle characterization is preferred Works closely with QC and Analytical Development to develop appropriate, well-characterized formulations, identify impurities, perform method development, and establish specifications Works across the organization to support internal drug product development laboratory capabilities at Sarepta's Burlington and Andover, MA sites Facilitates drug product development activities including formulation development, characterization, filtration, container closure qualification, and extractable and leachable testing Participates in Tech Transfer of new processes to CMOs including change controls, manufacturing batch record development, troubleshooting, and process validation Performs feasibility assessments of new laboratory techniques and technology concepts Documents all experiments in lab notebooks and reports

Desired Education and Skills:
This role requires expertise in biophysical characterization and analytical tools for small molecules and biologics, understanding of sterile drug product development, as well as experience working with external contract development organizations. Experience working with and characterizing gene therapies is a plus Ability and willingness to work in a laboratory setting are a must BS degree in Chemistry, Chemical Engineering, Biochemical Engineering or related science field. MA/MS degree preferred. 5+ years of related experience Understanding of formulation approaches to stabilizing against degradation in liquid or lyophilized dosage forms Experience developing and utilizing analytical methods for drug product characterization Knowledge and experience using biochemical or biophysical methods to characterize AAV-based viral vectors is desired but not required Ability to work cross-functionally and communicate effectively across CMC functional areas Experience with regulations and requirements such as cGMP, ICH, USPWillingness to learn new techniques and strategies to support drug product development capabilities Position may require some travel (expected to be minimal)

This position requires work on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

#LI-JL1

ArsenalBio's mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.

We are seeking a talented and motivated Senior Research Associate to join the ArsenalBio Technical Operations team. The individual will work closely with team members to develop analytical test methods and characterization tools in support of our cell therapy products. The individual will also interact cross-functionally across the organization to enable the success of ArsenalBio.

What You Will Do:Design, test, and implement fit-for-purpose analytical assays to support the characterization and release of cell therapy products.Independently develop ELISA and cell-based assay and qualify assays Plan and execute assays, and analyze data and timely deliver reports Provide technical expertise and leadership within project teams and in a matrix environment.Establish tracking and trending analyses of process development and cGMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve process standardization.Good understanding of cGMP environment, for process and assay development, qualification and validation preferred.Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges Organize, communicate, and present complex data sets to key stakeholders and senior management

What You Will Bring:Degree in Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry, or a related discipline Years of relevant experience in biopharmaceutical setting, and successful performance track record in establishing and applying analytical assays for cell therapy products as stated: Sr. Research Associate - Bachelor degree with 2+ years of hands-on experience in flow cytometry is preferred Expertise in ELISA and cell-based assay development Prior experience in T cell biology, cell therapy, industry, analytical development preferred Expertise in multi-color flow cytometry including panel design and data analysis, T cell functional assays (proliferation, cytotoxicity, cytokine/chemokine release), ELISA, and qPCR highly preferred Understanding of ICH guidelines, Quality by Design (QBD) principles, method qualification and validation preferred Ability to work in a highly adaptive environment and learn new skills for changing priorities Flexible and creative, with ability to think outside the box in order to problem solve Excellent communications and presentation skills, written and verbal Demonstrated ability to work in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines Willingness to expand scope of responsibilities outside of initial job description, with time
What We Will Offer You:
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.

We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (including candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.

We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.