Project Manager I, Manufacturing

The Allston Manufacturing organization consists of the following functional groups: Cell Culture Operations, Capture Operations and Business Operations. The primary responsibility of the Manufacturing organization is the faithful execution of the current set of instructions, ensuring practice matches procedure, to assure high product quality and compliance with current CGMPs and Quality standards. The Business Operations group oversees the indirect support of operations by creating the Manufacturing production schedule, execution of Quality Systems tasks including CAPA, Deviation, CCR and DCR workflows; Quality Risk Management; Business Continuity Planning; implementation and continuous improvement of the Manufacturing System (SMS) and project execution and management.

Responsible for supporting multiple manufacturing departments I areas. Enables execution of short and long term production plans through coordination of critical production operations, projects, complex CCRs, new technologies, training and general continuous improvement. May manage staff and/or cross-functional teams. Project/Production Management * Provides leadership, technical guidance, training and direction to Manufacturing staff in alignment cGMP requirements, department goals and corporate quality standards. * Ensures staff has appropriate knowledge of department processes and procedures to perform job responsibilities. * Leads cross-functional project teams and execution of critical manufacturing operations. Production Support * Leads Manufacturing staff on troubleshooting routine and non-routine operations to solve complex problems. * Creates instruction for new operations and coordinates training support for staff. * Providing technical leadership in process-related investigation. * Manufacturing suite activities: * Critical Operations * New Technologies * Projects * Complex Change Control requests * Assesses and identifies risk based strategies and approaches for enabling nonroutine manufacturing suite activities: * Commissioning and Qualification * Shakedown and/or Engineering Studies * Partners with Manufacturing Areas and Support Functions to proactively identify, assess, and mitigate operational and organizational risks. * Effectively demonstrates understanding of GMPs & how it applies to specific responsibilities. Acts as the technical manufacturing expert in cross-functional projects and performs SME and System Owner assessments for CCRs, ETP's and CTP's. An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes: * Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. * Being honest and treating people with respect and courtesy. * Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products. * Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs

Qualifications

  • Bachelor's degree and 3 years relevant operations experience in a cGMP Manufacturing Environment and 5 years of experience in a GMP industry

Preferred Experience

  • Extended experience in Equipment/Buffer Preparation, Cell Culture and/or Purification operations.

  • Demonstrated ability to execute production and project schedules.

  • Demonstrated ability to lead continuous improvement of technical and business processes.

  • Experience working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation. Strong documentation practices including batch production records, SOPs, OJTs and other controlled documents.

  • Experienced in troubleshooting, investigation, root cause and risk analysis in a CGMP environment.

  • Experienced in making tactical decisions on safety, process, scheduling and personnel-related issues.

Posted
01/01/2022
Type
Full time
Salary Range
$78,000.00 - 119,000.00
per Year
Salary range estimated by
Location
Boston, MA 02134, US
Apply Now