Manufacturing Associate I

Responsibilities:

The Manufacturing Associate I is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment. The incumbent works cross-functionally with internal departments and external resources on manufacturing related issues. The Manufacturing Associate I supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

• Performs manufacturing operations safely and compliantly in accordance with OSHA and cGMP guidelines. Manufacturing operations include but are not limited to, dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, filtration, product sampling, and filling of bulk product or intermediate.
• Assists in biomanufacturing production of biologics, as well as assisting with bioconjugation processes used in the manufacture of biologic drug substances such as mRNA therapeutics and Bioconjugates (ADCs, Oligoconjugates, etc.).
• Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.
• Performs oversight of process operations and monitors equipment and critical process parameters.
• Escalates any issues or abnormalities to management, senior associates and/or system matter experts.
• Participates in resulting troubleshooting activities as necessary.
• Completes set-up, use and cleaning (as necessary) of cGMP production equipment.
• Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate.
• Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations.
• Maintains a clean and orderly production area. Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.
• Participates in investigations of safety or quality issues as necessary.
• Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Engineering, Quality Assurance, Quality Control, Supply Chain, and Facilities
• Performs other tasks and assignments as needed and specified by management

Requirements:

Required Knowledge, Skills and Abilities:

• Ability to follow detailed instructions and to maintain accurate records and notes.
• Ability to work effectively in a team environment.
• Energetic, motivated and dynamic individual.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Education and Experience Requirements:

• BA/BS degree in a scientific discipline (synthetic /organic chemistry)
• 0-2 years of cGMP experience.

Physical Demands:

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds
• Frequently requires the use of a step stool
• Requires manual dexterity and visual abilities

Working Conditions:

Laboratory and office environment

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.