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- Senior Associate Scientist
Senior Associate ScientistJOB_530#######9405View Saved JobsSave job
- Job type Contract
- Location New Jersey
- Profession Other/tbc
- Industry Technology & Internet Services
- Pay $52.45 - $52.45/hr.
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Senior Associate Scientist - Contract - Summit West, NJ - $52.45 - $52.45/hr.The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.Applicants must be legally authorized to work in the United States. Sponsorship not available.Our client is seeking a Senior Associate Scientist in Summit West, NJ.Role Description•Provides support to maintain the site Statistical Process Control (SPC) program, manufacturing performance trending and reporting.•Provide multivariate 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 BMS standards and participating in best practice forums consistent with function responsibilities•Identify key Opex opportunities, using data driven evaluationsWorking conditions:•The incumbent will be required to adhere to the current BMS policies and procedures.•The incumbent will be required to gown to access classified manufacturing areas when needed.•This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.•This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.Skills & RequirementsQualifications Specific Knowledge, Skills, Abilities:•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 ManufacturingEducation, Experience, Licenses, Certificates:•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•Experience with Operational Excellence and Lean Manufacturing is a plus.Benefits/Other CompensationThis position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).Why Hays?You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.Nervous about an upcoming interview? Unsure how to write a new resume?Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.###.####.Drug testing may be required; please contact a recruiter for more information.#LI-DNI
