Senior Manufacturing Associate - Upstream

Position responsibilities:

• Perform operations of the following (may be applicable to development studies, clinical scale or validation activities)

• Strong knowledge and understanding of manufacturing process and equipment to perform various production steps

• Ability to train employees

• Subject matter expert operating production equipment, as needed

• Monitor and record batch parameters, including computer data entry

• Complete relevant paperwork following GDP/GMP guidelines as well as perform mathematical calculations related to production processes.

• Initiate new documents for procedures; may make minor revisions to existing documents.

• Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies.

• Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software.

• Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.

• Order, receive and distribute supplies into production area as needed.

• Pushing buffer containers ranging from 50L to 500L

• Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, Single-Use Bioreactor, Stainless-Steel Fermenter, analytical equipment

• Convey information to external stake holders (auditors, global colleagues, etc.) and oversee support for groups that support manufacturing (such as external cleaners, etc.)

• Lead Continuous Improvement Teams (such as 5S etc.).

• Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers

• Provide knowledge in areas of training process improvements

• Such additional responsibilities as the Company may also assign

Position requirements:

• With high school diploma: Normally requires 6+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred.

• With Bachelor’s degree: Normally requires 3+ years of related experience

• Demonstrated knowledge of CGMP manufacturing

• Knowledge of laboratory and pharmaceutical production equipment

• Able to read and follow detailed written instructions and have good verbal/written communication skills

• Able to write legibly and grammatically correct entries on records; must be able to author technical procedures and create forms

• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)

• Good computer skills, knowledge of Microsoft Word, Excel

• Good interpersonal skills and be able to work effectively and efficiently in a team environment

• Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule

• Ability to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements

• Must be able to lift and transport (using carts) packages weighing up to 50 pounds.

Preferred Qualifications

• Experienced in GMP upstream manufacturing; especially with large-scale single-use bioreactor, stainless steel fermenter, cell counter, and continuous centrifuge.

• Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing

• Characteristics: adaptable to changes, works well cross functionally and with key stakeholders. self-motivated, takes initiative and drives for solutions with the team. Can lead in the absence of the manager. Could train newer operators once up to speed

• Other possible responsibilities may include writing deviations/investigations and revising batch records if needed

Job Type: Full-time

Pay: $80,650.20 - $97,127.12 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Referral program

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Ability to Relocate:

• Waltham, MA 02451: Relocate before starting work (Required)

Work Location: In person