Manufacturing Science Associate I 1 Jobs

Assist in production planning, inventory management and material ordering

Under supervision, assume responsibilities for accuracy, quality, and timeliness of formulation results

Maintain records and the clean room environment to comply with safety requirements, good manufacturing practices and standard operating procedures

Strong technical skills, including a working and understanding of molecular biology and biochemistry

Demonstrated analytical, troubleshooting, math, and problem-solving skills

Demonstrated attention to detail and strong written and verbal communication skills

Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations

0-2 years of cGMP experience

Excellent oral and written communication skills

Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.

Completes setup, use and cleaning (as necessary) of cGMP production equipment.

Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate

1-3 years’ experience with product development or management of interactive products

Strong interpersonal skills and evidence of effective relationship management

Gaming, kid’s entertainment, or education sector experience

Familiarity with project management software such as Smartsheet, Confluence, or Jira

Contribute to brainstorming at all stages of product development of mathematics educational technology.

Support project leads to schedule meetings, document decisions, optimize workflow, manage correspondence between teams and vendors, etc.

Experience of FMEA's, SPC, Project Management, Lean Manufacturing, Error Proofing, and Root Cause Analysis

1-2 years of experience in the field

Thorough knowledge of manufacturing concepts, lean manufacturing, process documentation

Experience of using AUTOCAD and/or 3D solid modeling (CREO etc)

-Demonstrate excellent leadership, communication, interpersonal, analytical, and project planning skill

Bachelor’s Degree in Engineering field (Manufacturing, Mechanical, etc), or related field

Product life cycle monitoring and management experience with biologic or gene therapy products is preferred.

Experience using data management systems, analysis, and reporting tools is preferred.

Excellent written and verbal communication skills with the ability to communicate effectively across a number of disciplines and experience levels.

Prior experience and / or certification in a continuous improvement methodology (e.g. Six Sigma) is preferred

Responsible for Downstream process definition, qualification, technical support for AskBio’s late stage clinical and commercial gene therapy product portfolio.

Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification.

High School Diploma / minimum 0+ years of relevant experience or outstanding demonstration of skills or background

Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Strong planning, organization, and multitasking skills.

Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.

Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.

Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage the performance of the assigned task

Lead changes, innovation, and continuous improvements to optimize manufacturing and ensure effective capacity use while minimizing cost

Ability to identify issues, providing solutions, and forward-thinking through solid problem-solving

Excellent verbal communication, oral presentation, self-awareness, and the impact of communication and its working style on others

Medical, Dental and Vision Insurance

Company Paid Life, LTD and STD. Life Buy Up options for self and family

**Soft Skills: - Time management

**Desired Skills: - Knowledge of Creo/AutoCad

• Creativity, verbal and written communication skills, analytical and problem solving ability.

• 0-2 years experience required.

**Onsite or Remote: On-Site Full Time

• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.

Working knowledge and experience with lab equipment and computers

Good organization, attention to detail, basic troubleshooting aptitude, and clear technical writing skills

We are looking for professionals with these required skills to achieve our goals:

Performs hand-on operations (i.e. set-up, cleaning, solution preparation) per approved procedures and under cGMP guidelines

With guidance from senior staff, may perform and monitor critical processes

May assist in execution of routine validation and engineering protocols

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including:

Operation and understanding of word processing, spreadsheets, and data management

Knowledge of GMP and safety requirements.

An equivalent of 1 – 2 years of biologics industry experience required

Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes

Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Fermentation Process, Inoculation Process, Chromatography Columns, TFF step etc.

1 – 2 years of biologics industry experience required

Basic knowledge of buffer solution preparation or purification processing is preferred

Experience in single-use platform technology is preferred

Excellent written and verbal communication skills are required

Energetic, motivated and dynamic individual.

Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Knowledge of supply chain management and resource management practices.

Demonstrated experience managing facility, construction, or programmatic work with experience in procurement and inventory management.

Experience utilizing process improvement techniques such as Lean Six Sigma, Total Quality Management, etc.

Knowledge of and experience with ISO and/or NQA-1 quality drivers.

Knowledge of and experience with the Associate Lab Director for Weapons Production (ALDWP) programs including technical and operational disciplines.

Experience preparing and reviewing technical information, developing metrics and presentations.

And more benefits that come with working for a global industry leader!

5 years or more, with experience in manufacturing.

Hourly pay starting from $16.50/hr

Tuition Assistance & Employee Discounts

Must be 18 years of age

Required to work a 12 hour work schedule

Proficient in Microsoft Office and database management tools

Effective interpersonal, verbal and written communication skills to drive tasks to completion

Provides expertise in developing engineering solutions to improve the manufacture of new and existing Applied Composites products

Uses existing procedures to solve standard problems; analyzes information and practices to make judgments

Effectively exchanges straightforward technical information, asks questions and checks for understanding

Participates in the team's design and development work for new products

MINIMUM SKILLS, QUALIFICATIONS AND ABILITIES

Assist Product Cost Management team with cost estimates and value engineering studies.

Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Dependability: Consistently on time and at work, responds to management expectations and solicits feedback to improve performance.

Interact daily with NuScale design organizations to interpret their needs and requirements to manufacturing entities.

Contributes to the NuScale design organizations by applying knowledge of product design, fabrication, assembly, tooling, and materials.

Proactively works with senior associates, subject matter experts, and management to achieve training competency in production operations

Required 0-2 years related experience

Good organizational and communication skills, both written and verbal, and the ability to prioritize competing tasks

Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices

Completes setup, use, and cleaning (as necessary) of cGMP production equipment

Ensures work executed in compliance with company and regulatory quality policy and systems

Support experiments to test hypotheses based on in depth knowledge of process specialty

Assist in editing and/or reviewing standard operating procedures, technical reports and qualification/validation documentation

Bachelor’s degree or equivalent in Biochemistry, Chemistry, Engineering or a closely related field with one year of experience is required

Direct experience in protein process development function such as analytical, cell culture or protein purification

Knowledge is required in the methods of one or more of these specialties

Knowledge of GMP and GLP regulations

Maintain records to comply with regulatory requirements and performs daily in-process testing.

Maintain daily workload schedule and relevant resource requirements.

Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.

Experience with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment.

Perform a variety of complex tasks under general guidance and in accordance with current GMPs.

Draft, execute, document, and review data, and approval of SOP's and batch records according to GMP guidelines.

Experience in biologics manufacturing, sterile manufacturing, quality assurance or engineering areas is preferred.

Grade A, B, C and D gowning experience highly desirable.

Excellent oral and written communication skills. Strong technical writing ability preferred.

Medical, Dental, Vision, and 401K are all offered from day one of employment

Catalent offers rewarding opportunities to further your career!

Execute production activities that include cell culturing, aseptic processing, cell counts, expansion, separation and cryopreservation using appropriate techniques and equipment.