Process Development, Data Scientist II New Columbus, Ohio - Forge Biologics : Job Details

Job Title: Data Scientist II, Process Development

Department: Process Development - Downstream

About the Role:

The Process Development, Data Scientist II will provide active leadership and execution of the data analysis and documentation improvements for downstream process development efforts. This individual will be responsible for leading data science initiatives within the team, driving data science projects from conception to implementation, set up procedures, manage junior scientists, foster innovation within the process development department to advance viral vector manufacturing process. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.

What You'll Do:

• Focus on extracting insights from production data to identify areas for improvement, predict potential issues, drive efficiency, automate data pipelines, and create insightful dashboards to support development and manufacturing.
• Lead data structuring, perform data analysis to build data trends and patterns, model development, and statistical analysis.
• Ensure innovative technologies and methodologies are employed to maintain the highest data quality standards while ensuring that activities occur in an efficient and GDP-compliant manner.
• Generate reports and contribute to responses to both internal and external stakeholders.
• Independently present results, work with cross-functional teams where necessary to prepare publications or reports in alignment with key stakeholders.
• Become a subject matter expert (SME) for our electronic lab notebook system, Benchling, our documentation and training system, Quality Management System (Veeva).
• Work closely with process development scientists to apply advanced data analytical techniques to understand and optimize the manufacturing process.
• Providing training to process development team members on data science and analytics including but not limited to the training curriculum.
• Review study protocols, and technical reports and approve documentation.
• Ensure reports are written to highest standards and manage documentation review and approvals to meet deadlines.
• Ensure data is maintained in an accurate and controlled manner.
• Support internal process transfer activities from Process Development to GMP.
• Provide training, leadership, and guidance to the team, share resources on best practices, and provide feedback.
• Effectively manage a team of Data Scientists to support process development needs.
• Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.
• Collaborate closely with process development scientists, Manufacturing Sciences and Technology, cGMP, Compliance and Information technology teams to manage on the projects while adhering to relevant standards and company guidelines during product lifecycle.

What You'll Bring:

• Bachelor's degree in chemical engineering, Biomedical Engineering, Biology or related discipline (or equivalent experience) with a minimum of 10 years' experience.
• Experience in Data Science, Data Analytics, Data Engineering, or related discipline certification, or relevant coursework are a plus.
• Working knowledge of purification techniques such as chromatography, tangential flow filtration, clarification etc. is a plus.
• Understanding of manufacturing processes relevant to the industry (e.g., chemical engineering, pharmaceutical production)
• Knowledge of process control methodologies and quality standards.
• Proven ability to operate and troubleshoot purification equipment.
• Experience in planning, conducting, and reviewing experimental data with no oversight.
• Prior experience in training and development of other team members.
• Proven ability to manage team members effectively.
• Experience in analyzing datasets and utilizing the corresponding data to influence decision making.
• Skilled at organization and managing multiple projects simultaneously.
• Strong analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.
• Experience working with at least two of the following: Benchling, Excel, JMP, SQL, or Power BI.
• Robust understanding of regulatory requirements as they pertain to process development and characterization.
• Excellent communication and collaboration skills to work effectively with cross-functional teams and to convey complex data insights to stakeholders.
• Problem-solving and critical thinking skills to identify root causes and propose solutions.
• Experience in leading, mentoring, and guiding junior team members.
• Strong understanding and experience in Electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc. and regulatory requirements relevant to the industry.

Preferred Qualifications/ Skills:

• Master's Degree or PhD in Chemical Engineering, Biomedical Engineering, Biology, or related discipline (or equivalent experience).
• Experience working with viral vectors (AAV, Lentivirus, etc.).
• Experience directly managing junior team members.
• Previous data or Software Engineering role in Biology, Chemistry, or other Life Science Industry.
• Proficiency in Python, R, and SQL, Predictive modeling, hybrid modeling
• Experience in machine learning algorithms (regression, decision trees, neural networks)
• Familiarity with big data tools and cloud platforms (AWS, Azure)

Work Environment and Physical Requirements

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment.Ability to identify minute details within the field of vision, distinguish between distinct colors and accurately identify objects within a specific area.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce.Forge Biologics,provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

E NGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly Un FORGE ttable.

Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents

Competitive paid time off plan

Annual bonus for all full-time employees

401(K) company match

Fully-stocked kitchen with free food/drinks

12 weeks of paid parental leave - additional discount programs include childcare support & dependent care

Employee Assistance Program

Wellness benefits (financial planning services, mental health counseling, employer paid disability)

Onsite fitness facility

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