Manufacturing Specialist I

Job description

**Strong technical writing skills, experience with deviations, CAPA's, and change control**

**Leads cross-functional teams including working with Engineering, Validation, QA, QC, Facilities, Metrology, and MSAT**

Who You Are

You are a flexible learner who can take on multiple aspects of Manufacturing Operations. You have the ability to work across the organization to influence the Manufacturing Cultural and ensure adherence to procedures and GMP processes. You excel in a fast-paced and dynamic environment requiring problem solving and attention to detail. You enjoy working in a collaborative and supportive team setting.

Who We Are

Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage chromatography as part of a 24/7 large scale therapeutic protein manufacturing facility. The Manufacturing Specialist Organization’s main functions are leading deviation investigations, managing CAPA and change implementation, partnering with direct manufacturing staff for improving manufacturing operations, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives.

Where We Are

Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service. Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations.  Sanofi recently completed a multi-year capital expansion with several buildings constructed using “green” technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.  All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law

POSITION OVERVIEW/KEY RESPONSIBILTIES:

Position Summary:

The Manufacturing Specialist I uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.

Core Responsibilities:

·  Practices and promotes safe work habits and adheres to Sanofi safety procedures and guidelines.
·  Participates on cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
·  Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
·  Conducts document revisions and/or document management including batch production records and manufacturing procedures.
·  Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
·  Performs training with staff on the floor, as needed.
·  Trains new Manufacturing Specialists.
·  Participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Science and Technology.
·  Works under general supervision and direction.
·  Participates in determining objectives of assignment.
·  Performs work that may require independent decision making and the exercise of independent judgment and discretion.
·  Effectively utilizes Microsoft office applications.

BASIC QUALIFICATIONS:

·  High school diploma/GED with 3-5 years of experience, or Bachelor's Degree with 0-2 years' experience.
·  Knowledge of biologics manufacturing or a similar complex specialized environment.
·  Understanding of GXP and how it applies to specific responsibilities.
·  Excellent written and oral English language skills.

PREFERRED QUALIFICATIONS

·  Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
·  Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
·  Familiarity with Deviation Management Systems (i.e. Trackwise).
·  Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
·  Experience with deviation or investigation management systems.

LEADERSHIP QUALIFICATIONS:

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 Genzyme 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.

Leading People:

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 Genzyme 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.

SPECIAL WORKING CONDITIONS:

Ability to gown and gain entry to manufacturing areas.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.