171 Pharmaceutical jobs

  Pharmaceutical Process/Project Engineer Environment: Our client is seeking a process/project engineer to help augment the existing staff as well as help manage some of their lower scale projects ($200K and less) as well as perform change controls in a running GMP facility. Job Duties/Responsibilities: This individual must come from a Pharmaceutical or Biotechnology background. The client is looking for a process/project engineer that will be brought in to strengthen the existing team and must have experience performing change controls in a fully running GMP facility. In addition, the client would like this person to have some project management experience but from a much smaller scale. This person also should have either a chemical or a mechanical engineering degree. Required: Pharma or Biotech (Biologics) Process/Project Engineer (5-8 years of experience) Small scale Project Management ($200K projects or less) Change Controls Chemical or Mechanical Engineering Degree GMP

Job Description: The Lab Technician analyzes raw material, in-process intermediate, and finished products to meet quality specifications. Performs a variety of laboratory tests on raw materials, intermediates, and finished products. Sets up experiments and tests following detailed instruction and procedures. Maintains detailed documentation and data as a result of tests. Assists in updating operating procedures and batch sheets for various plant trials. Assists in the development of various analytical methods for the lab. Operates and maintains lab equipment and supplies.  Assists in instrument troubleshooting. Performs other duties as needed.

  Pharmaceutical Equipment Validation (Autoclaves) Project Description: Our client is a Pharmaceutical Contract Manufacturer who specializes in API Manufacturing.  Day to Day Responsibilities: Our client is a Pharmaceutical Contract Manufacturer who specializes in API Manufacturing. Our client is looking for an Equipment Validation Engineer who specializes in annual re-qualifications of autoclaves. They need this person to be well versed in pharmaceutical manufacturing equipment and it would be a huge plus if they had experience with API' s as well. They will need this person to come in the week after the New Year and get right to work.  Required Skills: Pharmaceutical Equipment Validation Autoclave Re-qualification Desired:  API Job Type: Contract 

Process Engineer (Product Transfers) Project Description Our client is a contract manufacturing organization that specializes in providing cGMP manufacturing and aseptic fill finish services to pharmaceutical and biotech organizations.  They are seeking a Process Engineer with experience handling product transfers for freeze drying and liquid fills.  Day to Day Responsibilities: Our client is seeking a Lead Process  Engineer who has experience handling product transfers. This individual would be supporting  freeze drying and liquid fill product transfers, and  must have experience working with pre-filled syringes.  Some of the areas the consultant will be working in are engineering assessment studies (cleaning and mixing studies) and risk analysis and risk assessments.   This  person needs to have a strong process engineering  background  and a minimum of 7 years' experience working in pharmaceutical cGMP environments.  This individual will be required to interact with both manufacturing and end client representatives, therefore  strong communication skills are necessary. This person should also be  confident speaking up in group settings.   The ideal consultant will be a self-starter who is comfortable working in a challenging and fast-paced environment.  Required Process Engineering  Product Transfers (freeze drying & liquid fills)  Pre-Filled Syringe Experience  Pharmaceuticals cGMP

Machine Operators-Blending/Weighting needed for Santa Fe Springs. Shift: 1st- 4:00 am-1:00 pm 2nd-1:30 pm-10:00 pm CALL or TEXT 562-402-3432 if you are interested! ASK FOR ERNESTO!  Responsibilities and Duties Machine Operators:  We’re hiring! Apply online today to become full time Blender in the city of Santa Fe Springs, CA.  Operate blender/screener Machine Audit ingredients batch to ensure all required ingredients are presents Set up material to maximize efficiency Load blender with all the ingredients. Follow Batch record instructions. Maintain process at standard speed Disassemble and assemble screens/Blenders Maintain out put consistency Minimize downtime and product waste Discharge powder from blender into a super sack. Ensure the application of GMP's and SOP's at all times. Ensure label placement and verify the alignment of the label on containers. Ensures lot code information is on the container. Ensure container is capped Ensure PVC band is on the neck of the container.  (If applicable) Ensure the general appearance of the finish good container is acceptable prior to be packaged. Communicates mechanical issues to line runner, lead or supervisor or mechanics Coordinates blender set up according to scheduled orders (set up blender, sanitation) Able to perform physical requirements-bending, heavy lifting, climbing, standing for long periods of time, etc. Adherence to local/federal OSHA & company safety requirements. Ability to clearly understand and follow instructions with minimum supervision. Attention to detail. Efficient time management skills and ability to work with others. Strong communication skills. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws , including the California Fair Employment and Housing Act (FEHA)*  IND3

Our client is an American biotechnology company that researches, develops and commercializes drugs.   Specific Job Requirements: Sourcer role rather than full cycle recruiter and it would be remote 100%.   The role will require, but is not limited to, the following duties and responsibilities: • Quickly establishing a clear understanding of the business needs and what activity is required to best support successful hiring • Being an active networker; participating in conferences and industry-related external activity • Identify critical and ongoing staffing needs through the development of talent pipelines - proactively contacting and managing ongoing engagement with potential candidates, connecting them with hiring managers and Recruiters and driving successful conversion to hires • Work closely with the I&D Lead to establish further routes to market • Drive external market knowledge and intelligence ensuring engaged talent is shared and visible across all relevant business units and geographies Knowledge, Experience & Skills • Relevant business Degree or equivalent experience • Significant experience in a strategic executive recruiter/talent role within Biotech/Pharma, likely to have prior experience as a Researcher in executive search or consulting • Deep experience in competency, behavioural and capability assessments to provide an evidence based approach to selection • Experience of recruiting across multiple geographies and functions • The ability to scout for talent with an I&D lens, with an understanding of global nuances • Fluent in English, ideally with an additional language (Italian, French, Spanish, German) • Excellent knowledge of MS Office and HRIS systems (Workday/Avature desirable)

Smith Hanley Associates Biostatistics Consultant Greater New York area Nihar Parikh - nparikh@smithhanley.com Our client, a leading consulting company, has an opening for a Biostatistician. You will work with global pharmaceutical companies and deliver lifecycle evidence strategy, clinical development, real world evidence, and drug commercialization. Execute SAP's, generate statistical reports and real world evidence analysis. Oversee statistical programming, data quality, and study plans. Monitor data quality, real world evidence analytics, and clinical reports. Oversee client deliverables and lead junior consultants. Seeking candidates with an Advanced Degree in Statistics, Mathematics, Biostatics, Computer Science or related field. 5 years of experience in the pharmaceutical industry or consulting with life science clients. Experience with real world evidence data, clinical trials analysis and strong statistical expertise required. Strong SAS, experience with observational studies, statistical modeling, predictive analytics and clinical data. Experience managing projects and client facing interaction. May require some travel to client sites. www.smithhanley.com

Smith Hanley Associates Senior Biostatistician Washington DC area Nihar Parikh, nparikh@smithhanley.com Our client has an opening for an experienced Biostatistician to provide statistical expertise, clinical trial design, and data analysis for clinical studies within multiple therapeutic areas. Responsibilities: -Oversee clinical development plans, SAP, and study design. -Support protocol development and provide strategic guidance for global project teams. -Lead regulatory submissions, provide regulatory strategy and interact with the FDA. -Support clinical study report writing and clinical publications. -Apply statistical principles and provide solutions to problems in drug research. -Provide statistical oversight to vendors, mentor staff and work with cross-functional teams. Qualifications: -MS/PhD in Biostatistics, Mathematics, or related field and 5+ years of experience in Pharma/Biotech. -Background in Cardiovascular, Oncology, Respiratory, Diseases or similar therapeutic area. -Experience in regulatory submissions, clinical development and statistical analysis plans. -Experience in program design, clinical study reports, statistical protocol and regulatory interactions. -Experience in SAS/R programming. -Strong interpersonal and communication skills. #GD www.smithhanley.com

Smith Hanley Associates Principal Biostatistician Remote - Work From Home Nihar Parikh - nparikh@smithhanley.com Our client, a dynamic CRO, has an opening for a Principal Biostatistician to oversee statistical reporting, study design, clinical trials, and project deliverables Responsibilities: Support clinical development projects, study design, and statistical protocol Review statistical programming requirements, clinical trials data, and quality outputs Oversee SAP's, regulatory procedures, and study level analysis Review CRFs and technical data standards such as CDISC Execute projects with clients and communicate results Assist with department procedures and business development initiatives Requirements: Advanced Degree in Biostatistics, Mathematics, Statistics or related field and 6-8 years of pharmaceutical experience Experience in clinical trial design and regulatory guidance Experience in SAS programming, drug development and SAP's Strong technical skills and project management Smith Hanley Associates is a niche recruiting agency. www.smithhanley.com

Title- Associate Director, Commercial Analytics & Insights -PHARMA Salary- $150-175k + bonus + (relo provided) Location- Greater Atlanta Area, GA Consultant -Eda Zullo, ezullo@smithhanley.com My client, a premier pharmaceutical company/manufacturer, is seeking an "Associate Director, Commercial Analytics & Insights" Professional! The main function of this position will be to provide analytic and insights to the TA. The ideal candidate will have a strong expertise in SAS, R and has a strong statistical background. Must be very strategic. Responsibilities * Ability to perform complex data analysis. * Ability to understand complex financial models and interpret financial analyses *Must have ability to be persuasive *Analyze data to provide actionable business relevant insights *Act as a SME regarding input and feedback on information and reporting systems Requirements: * BA /BS degree in a quant area / MA preferred *8+ yrs.' experience working in a PHARMA commercial analytics role using complex data *5+ Years of demonstrated success in analysis and modelling * Exceptional forecasting techniques-with monitoring in-line portfolio performance *Exceptional analysis and presentation skills to senior leadership *Strong knowledge of prescription data, longitudinal patient level data and formulary data *Experience in statistical techniques such as linear regression, logistic regression, decision tree, machine learning methods and time series forecasting techniques such as ARIMA, exponential smoothing *Ability to routinely demonstrate strong quantitative, data analysis, analytical and complex problem solving skills

Smith Hanley Associates Biostatistics Director Remote - Work from Home Nihar Parikh - nparikh@smithhanley.com Our client, a dynamic CRO, has an opening for a Biostatistics Director to lead all aspects of biostatistics and SAS programming. In this role you will manage a team and provide leadership on statistical deliverables, regulatory standards, and strategic guidance. Responsibilities: Oversee statistical protocol, SAP's, and regulatory submissions. Support CRF's, CDISC standards, and tables, listings and figures. Ensure data quality and accuracy of statistical reports. Communicate statistical concepts to regulatory agencies. Manage statistical and SAS programming teams. Oversee revenue reporting, monthly billing, and financial metrics. Review SOP's, strategy, client reports and regulatory issues. Assist business development initiatives, develop processes, and identify workforce improvements. Requirements: Advanced Degree in Statistics, Biostatistics or related quantitative discipline. 10 years of experience in a pharmaceutical or CRO organization and 3 years of management experience. Strong proficiency in clinical train design, SAS programming and regulatory guidance. Experience in Oncology or similar therapeutic area. Experience with clinical development, technical data standards, and submissions. Proven leader and technical expert. www.smithhanley.com #GD

Smith Hanley Associates Statistical Programmer, Associate Director Greater Pennsylvania area Nihar Parikh - nparikh@smithhanley.com Requirements: Lead programming teams and oversee statistical deliverables as well as department strategies. Implement data structures, manage resources, and collaborate with stakeholders. Guide regulatory initiatives and CDISC SDTM/ADaM standards. Manage projects and set strategy for the team. Support clinical plans and regulatory oversight. Qualifications: Advanced Degree in Statistics, Biostatistics or similar quantitative field. 10 years of statistical programming experience in a pharma or biotech organization across several therapeutic areas. Experience with clinical trial data, regulatory filings, and CDISC standards. Strong SAS programming and experience with relational databases. Experience leading programming projects and clinical development plans. Supervisory experience managing teams and mentoring staff. Experience delivering global submissions to regulatory bodies. To view our jobs please visit www.smithhanley.com

Smith Hanley Associates HEOR Leader Greater New York area Nihar Parikh, nparikh@smithhanley.com In this role you will lead global health economics and outcomes research, support regulatory guidance, strategic execution, market access, as well as collaborate with cross functional groups. Leadership role with high visibility in a growing biopharma. Responsibilities: -Develop global HEOR product strategies and contribute to clinical trials, data collection, and research design. -Implement HEOR projects such as evidence development, interpretation, and publication. -Manage a team of direct reports and provide strategic guidance for clinical development programs and market access. -Assist with HEOR deliverables and regulatory approval. -Support pricing and reimbursement decisions, provide therapeutic area value proposition and economic evidence. -Lead development decisions and support drug products from HEOR perspective. -Collaborate with cross functional departments such as the Market Access, Clinical Development, and Medical Affairs. Qualifications: -Advanced Degree in Public Health, Statistics, Epidemiology, Economics, or related discipline within Life Sciences. PhD or Pharm D required. -12+ years' experience in global health economics, outcomes research decisions and leadership in a pharma or biotech. -Strong analytical skills, statistical methodology, data analysis and strategic guidance. -Experience with leading HEOR teams, supporting drug launch, and applying HEOR principles in decision making. -Strong technical skills and interpersonal skills; proven leader and ability to engage stakeholders. www.smithhanley.com #GD

Smith Hanley Associates Senior Biostatistician (Associate Director) Greater New York area Nihar Parikh, nparikh@smithhanley.com In this role you will be responsible for analyzing clinical trials, coordinating statistical activities for drug development projects, study design, and working with cross functional teams. Responsibilities: -Provide clinical development strategies for study design, perform sample size calculation, and data collection -Perform statistical methodologies for clinical trials and develop statistical analysis plans -Prepare clinical trial reports and provide analysis for regulatory agencies -Perform statistical protocol review, conduct research, and oversee CRO activities -Work closely with cross functional teams and senior leadership to communicate clinical trial results -Provide solutions to technical problems and oversee deliverables such as publications Qualifications: -MS/PhD in Biostatistics, Statistics or related field and 10+ years of experience in the pharmaceutical industry required -Experience in SAP's, clinical trial design, statistical planning, and regulatory guidance -Strong SAS, statistical methodology, and data reporting -Regulatory submissions experience preferred -Experience managing CRO's and working with cross functional teams -Strong technical and project management skills www.smithhanley.com #GD

Smith Hanley Associates Data Manager - Clinical Greater New Jersey area Nihar Parikh, nparikh@smithhanley.com Responsibilities: -Oversee clinical data management activities, CRF development, database submissions and Oncology studies -Set up data validation, protocol review, and ensure FDA requirements are met -Work with cross functional teams including CRO's, statistical programming, and biostatistical groups -Support data review and analysis, SDTM, listings, and safety updates -Implement department standards, user acceptance testing, and data reconciliation -Design eCRF and resolve data issues Qualifications: -Bachelor's/Master's Degree in a quantitative field and 5+ years of hands on data management experience -Knowledge of global medical coding systems -Experience in Oncology preferred -Experience in good clinical data management practice, CDISC, and CDASH -Experience with Inform or EDC related software -Strong project management and leadership skills Smith Hanley Associates is a niche recruiting agency. Please visit us at www.smithhanley.com #GD

Smith Hanley Associates Biostatistics Lead Gaithersburg, MD Nihar Parikh, nparikh@smithhanley.com Responsibilities: -Indication lead and global submissions, statistical contributions to design -Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation. -Oversee Partners/CRO on Deliverables and Quality Standards -Apply statistical approaches for value demonstration and regulatory guidance -Global relationship development with collaborative groups, consultants, and international opinion leaders -Statistical staff technical mentoring/coaching and educational support Qualifications: -PhD/MS in Biostatistics, Mathematics, etc. -Experience in Healthcare/Pharma and Oncology, Respiratory, Cardiovascular, Diabetes or similar therapeutic area -Experience in statistical expertise to complex problems; extensive Regulatory and technical knowledge -Experience in Development, Program Design, Interpretation and Data Analysis -Submissions and regulatory interaction experience -Proven leadership experience www.smithhanley.com #GD

Smith Hanley Associates Senior/Principal Biostatistician Washington DC area Nihar Parikh, nparikh@smithhanley.com Exciting opening for an experienced Biostatistician to be part of a global biopharma with a robust pipeline of products. Responsibilities: -Oversee program design, modeling and simulation, as well as statistical innovation. -Provide statistical expertise, design clinical studies and lead project teams with regulatory strategy and HTA. -Deliver global regulatory submissions, contribute to clinical development programs and develop statistical analysis plans. -Manage CRO's and work with cross functional teams and senior leadership. -Lead statistical thinking and mentor staff with technical concepts. Qualifications: -MS/PhD in Biostatistics, Mathematics, or related field and 5+ years of experience in Healthcare/Pharma. -Background in Oncology, Respiratory or similar therapeutic area and strong statistical methodology. -Experience in regulatory submissions, clinical development and statistical analysis plans. -Experience in program design, statistical protocol and regulatory interactions. -Experience in SAS/R programming. -Strong communication skills and project leadership. Smith Hanley Associates is a niche recruiting agency: www.smithhanley.com #GD

Smith Hanley Associates Senior/Principal Statistical Programmer Washington DC area Nihar Parikh - nparikh@smithhanley.com In this role you will provide statistical programming support for drug products including analysis and reporting, clinical studies, regulatory submissions, commercialization, and technical standards. Responsibilities: -Oversee quality of deliverables and support clinical development plans, regulatory submissions, data reporting, and Oncology projects. -Deliver clinical study reports, SDTM/ADaM databases as well as tables, listings and figures results. -Provide statistical programming for regulatory submissions. -Manage technical database standards and programming specification documents. -Develop best practices and monitor safety/efficacy of the data. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -5+ years' experience in the pharmaceutical/biotech industry required. Background in Oncology, Respiratory, Cardiovascular, or similar therapeutic area and strong project management. -Experience in clinical drug development, regulatory requirements, CDISC standards, and data submission. -Experience in statistical programming, report publishing, and the ability to define business processes. -Strong SAS programming; Exposure to R, SQL, etc. a plus. www.smithhanley.com #GD

Smith Hanley Associates Director/Senior Director, Statistical Programming Washington DC area Nihar Parikh - nparikh@smithhanley.com Exciting leadership opportunity to join a global biopharma and oversee a team with statistical programming, regulatory submissions, data standards, clinical drug development, and foster decision making. Serve as core member of the programming leadership team. Responsibilities: -Manage a therapeutic area and direct programming projects. -Oversee quality of deliverables and lead clinical development plans, regulatory submissions, and data collection. -Manage clinical development programming, analysis and reporting, as well as information infrastructure. -Implement best practices, develop strategies, and improve statistical methodologies within drug projects. -Duties include standards development and technical guidance to meet business objectives. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -Proven leader in the pharmaceutical or biotech field and experience in statistical programming within clinical drug development. -Strong knowledge of CDISC standards such as CDASH, SDTM, ADaM, etc. -Strong SAS expertise and a background in Oncology, Respiratory, Inflammation or similar therapeutic area. -Experience in NDA/BLA regulatory submissions and good clinical practice. -Strong technical knowledge and people management background. Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/ #GD

Smith Hanley Associates Statistical Programming - Associate Director/Director Washington DC area Nihar Parikh - nparikh@smithhanley.com In this role you will lead programming projects, support regulatory submissions, clinical development plans, technical data standards and reporting within Oncology, Diabetes or similar area. Seeking experienced programmers with attention to detail and ability to manage multiple projects. -Provide statistical programming expertise, regulatory submissions, and manage the clinical development process -Manage direct reports and implement CSR development as well as statistical methodologies -SDTM and ADaM datasets, technical expertise and quality of deliverables -Information infrastructure, safety and efficacy of the data, quality improvements -Seeking candidates with a degree in Biostatistics, Applied Mathematics, Engineering, Life Sciences or related fields. -Extensive SAS programming and pharmaceutical experience required -Experience in Oncology, Diabetes or similar therapeutic area -Experience in CDISC standards, regulatory submissions, and clinical drug development -Advanced problem solving and ability to lead/mentor teams Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/ #GD