Sr. Specialist, Manufacturing, Clinical Drug Product

The Role
The Manufacturing Operations Support team is responsible for the day-to-day operational support of clinical and commercial drug substance processing and release through batch record review and continuous improvement projects. A Sr. Technical Specialist, Manufacturing uses extensive knowledge of manufacturing practices, bioprocess unit operations, process engineering and digital systems to act as a technical leader for the Clinical Drug Product manufacturing team. The Sr. Specialist will, independently and proficiently, lead in the development of operational procedures and training material, training manufacturing associates, supporting technology transfer activities, investigating issues that arise, and driving projects.
Here’s What You’ll Do
Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Practice and promotes safe work habits and adheres to safety procedures and guidelines. • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.

• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.

Provide on-the-floor coaching of the manufacturing team in execution of the process, troubleshooting, cGMPs and safety practices.
Serve as the manufacturing lead for tech transfers and other projects.
Leads cross-functional teams to drive complex manufacturing operation changes, improvements, and issue investigations.
Work with process SMEs to develop batch records, SOPs, and training materials.
Closely partner with QA colleagues for disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support.
Support the investigation and own CAPA implementation for manufacturing deviations.
Own and manage change controls for projects within the team.
Own the purchasing and induction of simple equipment and tools.
Participate in equipment start-up, commissioning, and validation activities.
Approve SOPs and batch records, change controls, technology transfers, and protocols as delegated.
Additional duties as may be assigned from time to time
No delegation authority associated with this role.
Here’s What You’ll Need (Minimum Qualifications)

Please refer the Job description for details