Formulation Scientist I

Job Description

Job Summary:

• In this role, the individual will support manufacturing operations by ensuring work is completed according to production schedules while maintaining the highest standards of quality, safety, and compliance.
• This position requires hands-on participation in manufacturing processes within a fast-paced environment, the ability to manage multiple production runs simultaneously, and strong organizational skills.

Duties and Responsibilities:

• Maintain a clean, safe, and compliant laboratory and production environment.
• Learn, follow, and adhere to departmental Standard Operating Procedures (SOPs), work instructions, and company policies.
• Prepare and initiate production procedures and documentation under supervision.
• Perform bio-conjugation processes in accordance with established protocols under supervision.
• Execute accurate laboratory procedures utilizing proper aseptic techniques.
• Accurately record and enter production data, observations, and results into databases and electronic systems.
• Assist with the revision and maintenance of controlled documents, including SOPs and batch records.
• Initiate and document problem reports related to production issues, deviations, or nonconformances.
• Monitor laboratory supply inventory levels and coordinate replenishment as needed.
• Perform inventory transactions and maintain accurate inventory records.
• Support continuous improvement initiatives and operational excellence efforts.
• Perform additional duties and responsibilities as assigned.

Degree/ Certifications:

• Bachelor’s degree in Biology, Cell Biology, Biochemistry, Biotechnology, or a related life science discipline.

Required Skills:

• 0–3 years of relevant experience, preferably within a GMP-regulated manufacturing, laboratory, or biotechnology environment.
• Proficiency with Microsoft Office Suite applications, particularly Excel, Outlook, and Word.
• Strong laboratory and quantitative mathematical skills.
• Excellent verbal and written communication skills.
• Ability to work effectively in a cross-functional and multidisciplinary team environment.
• Strong analytical, critical thinking, and problem-solving abilities.
• Demonstrated ability to contribute as a collaborative team member in support of successful project outcomes.
• Strong interpersonal skills with the ability to build positive working relationships.
• Ability to thrive in a fast-paced, metrics-driven environment while maintaining a high level of accuracy and attention to detail.

Preferred Skills:

• Chromatography experience/knowledge.

Physical Demands and Work Environment: 

• While performing the duties of this role, the employee is regularly required to sit, stand, walk, communicate, and hear.
• The position also requires frequent use of hands to handle, manipulate, or feel objects, as well as reaching with hands and arms. Occasional use of a step stool may be required to access materials or equipment. Specific vision abilities required for this role include close vision and the ability to focus on detailed work.
• Employees may occasionally be exposed to fumes, airborne particles, and hazardous chemicals while performing laboratory or manufacturing activities.
• The role may also require occasional lifting of up to 50 pounds.
• The noise level in the work environment is typically moderate.