Associate Cmc Process Data Analyst Jobs

Perform data transcriptions, method qualification, method trending, and light analysis on data received from external testing facilities

3+ years of industry experience

Experience in large molecule release such as protein concentrations, SE-HPLC, sterility, and endotoxin

Experience with pre-filled syringe testing

Experience with light analysis on CDMO provided data

Our client is seeking a Remote CMC Junior Data Analyst!

Ensure adherence to and develop best practices supporting Management Standards

3 to 5 years experience of data analysis tools such as Python, Tableau, Azure Data Products/Services and SQL

Ability to quickly understand and formulate application level requirements pertaining to complex workflows, or integration with external applications

Snowflake experience is a plus

Work closely with product leads, systems architects, data stewards, and developers to develop Data Cloud Architecture.

Develop Subject Matter Expertise on the key data elements that are consumed for reporting data to downstream and upstream apps

Has licensed content that consists of over 100,000 videos, generating 40 billion monthly watch-time minutes.

They are at forefront of the Creator Economy

Closed Series D at $1.75 Billion

Made Top #10 SaaS companies and ranked #9 out of 10 (above Spotify)

Viewing reports/understanding the analysis/ break down business problem to pass to Analytics Engineer

Exp. Analyzing data & coming up with a meaningful answer

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Enable the successful implementation of new process analytics tools through cross-functional collaboration focused on requirements, design, and maintenance

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Ability to apply strong verbal and written communication skills in a dynamic, cross-functional matrix environment

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Family care benefits, including subsidized back-up care options and on-demand tutoring

Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred

Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items

5 years of technical CMC small molecule experience in the biotechnology or pharmaceutical industry

Experience in a cGMP environment is required; drug substance and/or drug product manufacturing experience preferred

Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles

This is a remote-based position located in the United States.

· Strong analytical skills and demonstrated problem-solving ability

· Experience working with large datasets

· Working knowledge of Python or R preferred

· Ingest, review, and evaluate large volumes of music reporting data

· Prepare analysis, reports and insights on prospective music catalogs

· Review, evaluate and analyze music royalty reporting statements and other revenue reports

A professional development fund for continued learning about education, data storytelling, and/or technical skillsets

A strong believer in and committed to Beyond 12’s mission, vision, and core values: Collaboration, Excellence, Innovation, Knowledge, Respect, and Trust

Technically skilled with data analysis and visualization tools, including proficiency with Excel, Python, and SQL, and familiarity with Looker

A competitive benefits package that includes but is not limited to:

Stage student data in a timely and accurate manner by using automated scripts to ensure data integrity and consistency

Create and maintain detailed documentation of data processes, ensuring a comprehensive understanding of data sources, defnitions, cleaning, and transformation processes.

Education assistance (tuition, student loan, certification support, dependent scholarships)

Family support through fertility and family building benefits with Progyny and adoption assistance.

Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.

With direction, utilize basic SQL language skillset to troubleshoot and test reporting objectives.

Utilize problem-solving skillset to triage and solve fundamental business problems and issues

Demonstrated oral, written, and technical communication skills required.

Strong sense of planning and prioritization, and the ability to work with all levels of management.

Ensure that CMC content is complete, well-written, and meets all relevant requirements.

Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.

Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.

Excellent interpersonal skills to communicate difficult concepts and persuade others.

Strategic thinking and strong problem-solving skills with outstanding attention to detail.

Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings

Job Title: CMC Project Manager - Remote

Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables

Assist PD in driving decision making and communication

Pay Rate: $70/hr to $75/hr

Apply project management expertise across the portfolio for standard and complex projects, managing multiple projects in parallel.

Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.

Report on project progress, offer viable solutions and opportunities as they arise

Work with internal and external stakeholders to manage project deliverables, e.g., CMOs, Supply Chain, etc.

Excellent interpersonal, communication, and presentation skills.

Strong leadership skills and executive presence; ability to positively influence outcomes.

Manage multiple data cleansing priorities and participate in data cleansing projects.

Data entry, collection, and interpretation

Understand and manage complex relationships among various business data sets

0-1 year of experience in system administration, business intelligence, data analytics, sales support or related field.

Experience in the healthcare industry

Effective verbal and written communications skills; effective presentation and negotiation skills with demonstrated ability to facilitate cross-functional team projects

Assist in meeting with report stakeholders for requirements gathering, progress, and signoff

Develop and maintain Power BI reports and communicate with various technical and non-technical teams to develop data and report requirements

Bachelors' degree in a related field such as statistics, mathematics, computer science, data analysis OR equivalent years of experience

2-3 years of experience with Power BI Desktop, DAX and Power Query to transform data and create custom calculations

Ability to communicate effectively and gather detailed requirements

Experience with design-thinking and/or desire to support user-experience design is a plus

Identification, selection and management of CDMOs for process development, process optimization, GxP manufacturing and analytical activities for drug-substance and drug-product

Direct experience working with FDA, including knowledge of current ICH guidelines

In depth understanding of modern process development, solid state characterization, hands on cGMP manufacturing and CDMO management

Establish and manage all CMC internal and external activities related to process development, manufacturing and validation for our programs

Ph.D. in Chemistry or related discipline with at least 15+ years of industrial experience in Process Chemistry and Drug Development

Strong track record of drug discovery experience, success, and leadership, exemplified by advancement of programs through multiple stages of development

A minimum of 1-3 years of experience within a cGMP environment in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.

Technical CAR-T knowledge or Biotech process knowledge preferred.

Clear and succinct verbal and written communication skills.

Support investigations to provide manufacturing data for deviation investigation and support with data analysis and visualization as required.

Support Manufacturing Dashboard activities including updating, maintaining and creation of new visualizations.

Ability to work with paper and electronic system for data compilation including MES, SAP, LIMS, etc.