Senior Manufacturing Associate Jobs in Massachusetts

Proven track record in successfully managing complex manufacturing operations, including client engagement and project management.

Collaborate with clients to understand their unique requirements and tailor manufacturing strategies accordingly.

Drive employee engagement and professional development initiatives to cultivate a skilled and motivated workforce.

Minimum of 12 years of progressive leadership experience in biologics manufacturing within a CDMO or pharmaceutical company.

In-depth knowledge of upstream and downstream bioprocessing techniques, technology platforms, and equipment.

Strong understanding of cGMP regulations, quality systems, and regulatory requirements for biopharmaceutical manufacturing.

Project management experience is required

8+ years' experience in equipment-intensive ISO 9000 manufacturing

Plastics processing experience is a plus

Develop, implement, and validate manufacturing processes for existing and new products

Lead verification and validation exercises for commercial manufacturing launch

Address non-conformances through NCR/CAPA system, escalating when necessary

Estimate production times, staffing requirements, and related costs to provide information for management decisions.

Confers with management and other staff regarding manufacturing capabilities, production schedules and other considerations to facilitate production processes.

Excellent written and verbal communication skills. Prior experience in technical writing and procedure development.

Prior experience in machine shop practices including milling, turning and grinding a plus.

Previous experience with automation a plus.

Experience with mechanical design using SolidWorks.

Contribute or author Quality Management System documents as assigned.

Establish the knowledge to operate and monitor manufacturing equipment and process during production of Cell Therapy products.

Profound cGMP skills and leads by example.

Perform responsibilities according to procedure while maintaining compliance and safe operating practices.

Utilize process knowledge to influence positive change during the review and revision of Standard Operating Procedures (SOP’s) and Batch Records.

Essential duties and responsibilities include the following (other duties may be assigned):

Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems

Accomplish work in a safe manner, notifying management of safety risks

Participate in tiered visual management system and support continuous improvement programs

Develop equipment and process qualifications and validation

Maintain training requirements and act as a qualified trainer

Experience with business systems such as, LIMs, MODA and other business systems