What are the responsibilities and job description for the Senior Associate Scientist position at ECLARO?
Senior Associate ScientistJob Number : 25-03863Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Senior Associate Scientist for our client in Summit, NJ.ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!Position Overview : The Senior Scientist of Biostatistics is a member of the MSAT team, with focus in CPV (Continued Process Verification) and APQR (Annual Product Quality Review) reporting. The consultant will support the monitoring / trending of production and release testing parameters, in support of product of personalized cell therapy products for both global commercial and clinical trial supply. The consultant will trend CPV parameters, including but not limited to manufacturing process parameters and quality control release attributes for the MSAT organization, to support the Client facility. The purpose of a CPV program is to provide evidence that a process is running under a state of control. The consultant will monitor / trend, alerting stakeholders of any drifts and supporting the data reporting of process parameters to the global MSAT organization, while meeting established timelines. The CPV program includes supporting the APQR, as required by regulatory agencies. The consultant will support the CPV and APQR reports and approvals. The organization being supported is a 24x7x365 manufacturing facility. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Client. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MSAT.Responsibilities : Provides support to maintain the site Statistical Process Control (SPC) program, manufacturing performance trending and reporting. Provide Multi-Variate Analysis (MVA) modeling for improved process understanding and robustness. Continuously monitor CPV parameters, evaluate Statistical Alert Events (SAEs), and take needed actions. Collaborate and support investigations by providing data and analysis. Meet CPV and APQR timelines. Establish and support predictive process monitoring analytics. Supporting any proactive initiatives or investigations related to drift in product performance. Represent the site MSAT CPV team in cross-functional forums. Performing review and approval of site documents within the scope of CPV and APQR. Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; actively supporting regulatory inspections. Interacting with other teams including Operational Excellence, PMO (Project Management Organization), site MSAT, Global MSAT, Quality Assurance, Process Support / Engineering and Manufacturing Support, Manufacturing Operations, Supply Chain Operations. Staying current with industry trends and Client standards and participating in best practice forums consistent with function responsibilities. Identify key Opex opportunities, using data driven evaluations.Qualifications : Excellent knowledge of evaluating data using statistics and statistical tools, to make data driven decisions. Proficiency in major statistical software packages and programming languages (e.g., R, JMP, MINITAB, or SAS), JMP software, preferred. Must be detail oriented and proven track record of impeccable time management, to meet timelines. Possess strong verbal / written communication skills to enable working with internal / external parties and / or collaborating with cross-functional teams. Expert knowledge of cGMP’s and multi-national biopharmaceutical / cell therapy regulations. Experience of facility / clean room design, process, equipment, automation, and validation. Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities. Hands-on experience with single-use technologies, closed systems, and cold chain / cryogenic technologies. Experience with Operational Excellence and Lean Manufacturing, Bachelor’s Degree, required (Science or Engineering is preferred); Graduate or higher-level Degree is preferred. 8 or more years of work experience in the Biopharmaceutical or related industry. 8 or more years of manufacturing support or related experience in the Biopharmaceutical Industry. Experience in CPV and / or APQR reporting, preferred. May be substituted for relevant experience in monitoring / trending performance of quality attributes. Experience in cell Therapy, Biologics, or Vaccine Manufacturing / Support, required.If hired, you will enjoy the following ECLARO Benefits : 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLAROIf interested, you may contact : June Binuyajunethel.binuya@eclaro.com212-804-7476June Binuya | LinkedInEqual Opportunity Employer : ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
