Cell Therapy Manufacturing Associate pharma or biotech exp

Top Skills

• Bachelor's degree in Life Sciences – Preferred
• Experience in regulatory controlled environments

The primary purpose of the Manufacturing Associate role is to complete production assignments with high quality and timely output in a cellular therapeutic manufacturing environment.

• Work on routine manufacturing assignments per written procedures, recognizing deviation from accepted practice.
• Adhere to Good Manufacturing Practices and standard operating procedures.
• Weigh and check raw materials; assemble, clean, and sanitize process equipment; monitor processes.
• Complete work instructions and maintain a clean room environment to comply with regulatory requirements.
• Train for proficiency in the operation of primary production equipment within the assigned functional area.
• Train for proficiency in process systems (e.g., Syncade MES, Oracle interfaces) and supporting business systems (e.g., Oracle, ETQ, BMRAM).
• Assist with the revision or creation of process documents such as SOPs and electronic work instructions.
• Assist in maintaining material and component inventory levels.
• Support a safe work environment.
• Work in teams and collaborate with manufacturing team members to exchange information about batches in process.
• Resolve routine problems and make recommendations based on judgment.

• Associate's or Bachelor's degree in life sciences field preferred; minimum of high school diploma and/or equivalent combination of education and experience is required.
• 0–2 years of cGMP manufacturing experience desired, or equivalent work experience or education.
• Proven experience working on teams where combined contribution, collaboration, and results were expected.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheets, and web-based applications.
• Attention to detail and personal accountability are critical for success.
• Good interpersonal skills; attentive and approachable.
• Maintains a professional and productive relationship with area management and co-workers.

• Must be able to stand or walk for extended periods.
• Must be able to work in a cleanroom environment and perform aseptic processing, requiring appropriate gowning and personal protective equipment (e.g., safety shoes, safety glasses, aprons, face shields, powered air purifying respirators, lab coats, full body gowns, hairnets, gloves, hearing protection).
• Required to carry or lift up to 30 pounds (15 kg) several times a day while handling production equipment and/or materials.
• Required to push or pull up to 50 pounds (25 kg) several times a day while handling production equipment and/or materials.