• Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

• looking internally and externally for best practices and areas for improvement.

• Provide direct oversight for the Manufacturing operation with the following specific responsibilities:
  • Ensure that products are produced and stored according to the current set of instructions;
  • Ensure practice matches procedure;
  • Ensure appropriate maintenance and a state of qualification is maintained for equipment and facilities in area of responsibility
  • Ensure all personnel, including contractors, consultants and temporary employees who work in Manufacturing and directly or indirectly support a cGMP activity, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
• Ensure that all Manufacturing and Warehouse activities are in performed in compliance with CGMPs.
• Ensure that Manufacturing and Warehouse staff are sufficiently trained to perform their job responsibilities and that each has an approved job description.
• Oversee, either directly or indirectly, Manufacturing investigations, CAPA, process variances and deviations. Ensure that all Manufacturing owned change control, CAPA, and deviations are completed by the due date.

• Ensure Manufacturing and Warehouse work practices are in accordance with the Genzyme/Allston Safety Programs.
• Establish departmental and individual goals and objectives in alignment with site goals and priorities.
• Identify the required resources and expertise, implement the appropriate team/departmental structures and establish the required processes and communications to enable department(s) to effectively deliver on all commitments.
• Develop strategies that ensure achievement of Manufacturing objectives and drive overall improvement in plant performance that are consistent with the site's strategic direction.
• Support and/or lead overall efforts to build a reliable patient supply while addressing Consent Decree requirements including remediating Allston Quality Systems, upgrading the facilities and equipment and establishing capable, compliant manufacturing processes for Cerezyme and Fabrazyme
• Active member of the Allston Operations Leadership Team.
• Define and hire necessary resources to meet Manufacturing objectives. Ensure effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
• Strengthen overall leadership and organizational capabilities in area of responsibility. Build and sustain a high performance management team and ensure strong alignment and coordination with other functional groups at the site.
• Ensure team members achieve their potential and the teams meet their goals. Develop succession plans for the Manufacturing organization.
• Provide technical leadership to the Manufacturing organization and keep current on trends and new technologies and developments in area of responsibility.
• Manage headcount and participate in setting the site annual budget and quarterly forecasting processes. Oversee and manage the Manufacturing budget to plan.
• Participate in the development, revision and accuracy of the short range and long range production plans.
• Undertake long and short-term planning and supervision of projects that require cross-functional interaction, alignment and coordination.
• Lead the Manufacturing team to excellent performance through a structured manufacturing system with the use of Operational Excellence tools.
• Manages employees, either directly or indirectly, who are involved in the scheduling, implementation, execution and/or maintenance of manufacturing processes and operations.
• Anticipate, identify and communicate risks in area of responsibility and across the site; create strategies and plans to manage risk to the operations.
• Create functional excellence for area of responsibility and helping to integrate that capability into daily operational practices.
• Work closely with peers and counterparts at other sites and across functions to drive manufacturing excellence, share best practices and lessons learned to create industry-leading manufacturing of medicine for patients.
• Maintain performance metrics and routinely issue reports.

• Bachelors or Master's degree in the Life Sciences or Bio/chemical Engineering and at least 15 years of progressive technical/operational leadership experience or equivalent.
• In-depth knowledge of biopharmaceutical cGMP manufacturing operations (especially large scale cell culture) is critical.
• Demonstrated ability to manage multiple complex functional areas and achieve significant business results
• Track record in successfully managing large, complex manufacturing operations in the later stages of a plant life-cycle
• Demonstrated ability to develop self; build high performance teams, develop others.
• Excellent communication skills and ability to influence and build relationships across the broadest constituencies both internal and external to the site

• Progressive management experience in at least one other core functional area (Quality, Development, E&F) is ideal
• Track record in successfully managing manufacturing operations during multiple stages in the life-cycle of a manufacturing plant (start-up, growth, steady state and declining phases)
• Solid understanding of Health, Safety, Environmental and legal requirements for operations
• Excellent problem solver and able to generate innovative solutions to broad range of issues
• Excellent people leadership and change leadership skills.
• Ability to set ambitious and realistic targets, drive execution and build culture of continuous improvement and accountability. M*

• Performing record review necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor
• Conducting reviews of manufacturing processes to ensure compliance
• Conducting reviews of testing results in support of release of intermediates
• Assisting in deviation/nonconformance identification and resolution.
• May interpret complex, explicit documentation to ensure quality standards and compliance
• May provide training to new employees

• Bachelor's Degree and 2 years Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent OR 5years experience in Quality and/or Operations experience in a CGMP Manufacturing
• environment or equivalent
• Knowledge of CGMP regulations for US, EU and other markets
• Experienced with CGMP documentation review

• Industry bio-pharmaceutical experience
• Strong computer, verbal and written communication skills
• Strong technical writing skills
• Effective time management, detail oriented, organizational skills, teamwork, collaboration
• Assisted in deviation/nonconformance identification and resolution.
• Participated in team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution
• Trackwise system experience
• Management Inventory system experience M*

• Selects, develops, and motivates qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
• Provides leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
• Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
• Develop work plans, assign tasks, and supervise team(s).
• Ensure staff has appropriate knowledge of department processes and procedures.

• May provide input into the department budget.

• Establish and report applicable department or organizational metrics.
• Accountable for project completions and achievement of compliance goals.
• Represent department in meetings.
• Interact with project teams and cross-functional groups.
• Address and/or escalate CQO compliance problems and issues.

• Respecting the laws and operating within the applicable 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.

• Ship, receive, and store and distributes materials, parts, supplies, and equipment
• Record movement of incoming and outgoing materials and verify the accuracy of work performed
• Use business system for raw material and non-stock receipts
• Contact Buyer/Planner to resolve discrepancies.
• Enter cycle count results.
• Execute final shipment confirmation of customer orders

• HS diploma and 1 - 3 years' related warehouse operations experience

• Ability to lift 35 - 50lbs
• Ability to operate powered industrial trucks (PIT)
• Strong computer and math skills
• Ability to work in various environmental cold rooms

• Ability to work rotating shifts, overtime and weekends
• Knowledge of general warehouse and inventory control
• Prior experience working in cGMP environment

M*

• Determines and sets the scheduling of equipment preventative maintenance, calibrations, work orders and validation studies to minimize the impact to the manufacturing schedule
• Responsible for planning system and equipment maintenance & calibration schedules for department
• Reviews unscheduled work orders for material needs.
• Regularly leads the daily scheduling meetings.
• Assign and track work orders throughout the department
• Establish work load for shifts in coordination with dept. Supervisors in order to prioritize and balance daily workload with the schedule, staff availability, corrective work orders, etc
• Coordinate vendors and vendor activities to align to schedule.
• Monitoring plant's daily schedules, and develops and maintains schedule communication tools (ie communication boards, scheduling web site, etc.)
• Takes appropriate action when material or staff delays need to be elevated to the appropriate personnel.
• Work independently under minimal supervision and direction.
• Regularly leads projects and/or assignments
• Work in cross-functional teams; oftentimes directly leading the teams.
• Provides training and direction to less experienced staff.

• High School Degree with 6-9 years in manufacturing operations or scheduling
• 4-7 years' experience with facilities/calibration operations

• Bachelor's Degree
• Prior cGMP experience
• Knowledge of MRP concepts and/or Calibration Methodology
• Ability to communicate effectively to all levels of management
• Basic understanding of cell culture bulk manufacturing process
• Proficient in MC Office, Vision, Excel M*

• Ensuring the establishment and continuous improvement of the Plant QA function for the following areas: bulk manufacturing, laboratory operations and facility and engineering
• Ensuring sound release decisions that adhere to multiple jurisdictional requirements
• Establishing and chairing the nonconformance review board for all significant deviations ensuring that sound decisions are applied to adequately investigate root cause and ensuring appropriate CAPA's and CAPA effectiveness are applied
• Quality approval for all critical risk assessments and corresponding CAPA's
• Ensuring that all product quality related decisions adhere to the expectations of multiple jurisdictions
• Leading the consent decree remediation of the Quality organization
• Continuously improving all Quality and 3rd party oversight interactions
• Focusing internally and externally; interacting internally with subordinates, peers, and senior management and interacting externally with regulators, customers, and contract manufacturers
• Maintaining an external network of expertise and represents the company in professional organizations

• Providing effective leadership including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with performance calibration/talent pool management/succession planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in the management of their employees/department which support achievement of individual/department/business objectives
• Ensuring compliance with all legal and business requirements and Genzyme policies and practices.
• Establishing departmental and individual goals and objectives in alignment with site goals and priorities. Identifying performance improvement targets and metrics. Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets.
• Strengthening overall leadership and organizational capabilities in area of responsibility. Building and sustaining high performance management team and ensuring strong alignment and coordination with other functional groups at the site.
• Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
• Identifying and communicating risks in area of responsibility and across the site; creating strategies and plans to manage risk to the operations.
• Participating in development of site long range in line with the corporate Long Range Planning.
• Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
• Managing headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.
• Motivating, retaining and developing key employees. Building and sustaining employee engagement by creating an environment within which individuals and teams can excel.
• Interacting closely with BU, relevant sites and functions to define production plans, yearly goals and budgets for reporting functions/operations as well as long range plans (LRP and LRCP).

• Bachelor's Degree in a science or technical field and 12 years of experience in pharmaceuticals or a related industry with 10 years in management position or an equivalent combination of education and experience

• Knowledge of biotechnology processing and testing
• Proven experience in leading a multi-tiered and quality diverse operation
• Proven experience in establishing a Plant QA function for the approval of batch records, BOM, NC's, Work orders, CAPA's and Change Controls in an efficient and sound process
• Project management skills
• Thorough knowledge of GMPs
• Expertise in applying quality principles to manufacturing, facilities and engineering and laboratory testing for the manufacturing of biopharma products
• Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions
• Knowledge and experience with discrepancy investigation and lot disposition
• Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives. Strong collaboration skills.
• Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
• Driven with a strong focus on goals M*

• Select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of
• variables.
• Initiate and complete routine technical tasks.
• Actively participating and providing input, feedback for the Genzyme Safety Program to meet Health and
• Safety regulations and OSHA requirements in all duties.

• Function as a technical resource to equipment or systems regarding troubleshooting operations. Actively
• involved in daily operations when required to meet schedules or to resolve manufacturing challenges.
• Routinely audit the operational performance and regulatory compliance of a moderate number of equipment
• components or systems of significant complexity.
• Work with manufacturing, maintenance, process development, facilities, quality assurance and other
• departments in developing requirements and recommendations for system modifications.

• Complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects and engineering firms on development of standard design documents.
• Obtain and critique quotes for equipment modifications or installations.
• Generate rudimentary project cost estimates and schedules.

• Provides technical direction/training to line level and line level supervision personnel.
• Provides technical support for investigations and provides on the floor technical support.
• Frequent use and application of technical standards, principles, theories, concepts and techniques.

• Utilizing quality systems to measure, analyze, and improve individual performance
• Partnering with peers, team members, direct and indirect management chain to ensure the following:
  • Training Plan execution.
  • Ensuring Inspection Readiness of assigned areas
  • Participates in timely completion of investigations
  • Ensuring deviation are closed in a timely manner
  • Provides support for deviations and department documentation changes.

• Bachelor's degree in Engineering, Science or related technological field
• 3+ years of relevant work experience with 1+ year experience in operations/manufacturing environment.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) preferred.
• General understanding of Quality systems
• Basic understanding of GMPs and the connection between these and CFRs.

• Chemical Engineer, Mechanical Engineer
• 6+ years of relevant work experience with 5+ years experience in operations/manufacturing environment.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

• Working knowledge of pharmaceutical/biotech processes
• Familiarity with documentation in a highly regulated environment
• Ability to apply engineering science to production.
• Demonstrated skills in the following areas:
  • Problem solving and applied engineering.
  • Technical report writing
  • Verbal communication
  • General understanding of validation protocol execution requirements.
  • Some Demonstrated Skills in the following areas:
  • Personal Organization
  • Analytical Problem Solving
  • Computer Literacy M*

• Performing process data analysis, process modeling, and experimental studies across diverse areas including cell culture, chromatography, filtration, and lyophilization systems
• Modeling and troubleshooting large scale manufacturing processes
• Supporting development of novel data analysis tools, modeling tools, and experimental approaches to assist in process investigation and to enhance process understanding
• Performing heat/mass transfer, mixing, and modeling studies to support process equipment characterization, design, change, validation, and technology transfer
• Staying abreast of new developments/technologies in areas of responsibility
• Participating in evaluating, establishing, and implementing new platform technologies
• Developing standard practices and facilitating harmonization/technology transfer among sites

• MS degree in Chemical or Biochemical Engineering, or related engineering discipline with 0 - 1 years relevant experience in the biopharmaceutical or pharmaceutical industry or BS degree in Chemical or Biochemical Engineering, or related engineering discipline with 1-3 years relevant experience in the biopharmaceutical or pharmaceutical industry

• Demonstrated capability to apply engineering principles to real world problem solving, as well as the ability to grasp the underlying technical essentials and business needs
• Demonstrated ability to develop modeling and experimental approaches to address scientific queries, analyze data, and draw conclusions through independent thinking and collaboration with team members
• Training/experience in data analysis, programming, and modeling
• Strong oral and written communication skills are essential

• Experience with advanced data analysis/programming tool (JMP, Matlab, MathCAD) is preferred
• Experience with process modeling such as Simulink, gPROMS, Aspen is desired
• Multidisciplinary knowledge of wide range of scientific and engineering principles is highly desirable
• Background in BioProcessing, Pharmaceutical, Biotechnology, or cGMP experience is preferred

M*

• Primarily responsible for hands on execution of experimental work in the Manufacturing Sciences laboratory.
• Interact with colleagues from the site MTS teams and other functions
• Provide technical support to GMP operations in a multi-product cell culture and purification plant.
• Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
• Develop process knowledge and ownership.
• Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc.).
• Provide technical support and analysis for the resolution of deviations, investigations and process issues.
• Identify, own and resolve process issues proactively.
• Lead the proposal, initiation, testing and implementation of minor proposed changes to cell culture processes
• Completes technical investigations and provides technical expertise.
• Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non-conformances.
• Participate in cross functional initiatives.
• Keep abreast of new developments/technologies in areas of responsibility.

• 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.

• BS in engineering with at least 3+ years, or MS in engineering with at least 1+ years relevant experience in a cGMP manufacturing environment.
• Hands-on laboratory experience in biotechnology protein purification processes.
• Knowledge of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
• Understanding of compliance and cGMP considerations.
• Demonstrated commitment to continuous improvement - at the individual, department and organizational levels.
• Experience with high level data analysis and strong technical writing skills

• Experience in the scale up and operation of large scale biotechnology processes.
• Hands-on experience with large scale biotechnology unit operations.
• Process development experience is highly desirable.

• Ensures that change controls approved by the Change Control group meet the requirements of Genzyme standards and procedures, are clearly written, and appropriately justified. Oversees and monitors those changes at various points in the change life cycle, utilizing a TrackWise electronic workflow.
• Provides guidance to Manufacturing, Quality, Engineering and Facilities departments regarding whether proposed changes are to be handled through the document change process, or through the change control process applicable to validated processes, equipment and test methods.
• Trains staff and key users of the change control system on regulations, SOPs and policies. Provides mentoring and guidance to users on clear and concise wording of change controls.
• Applies and interprets Genzyme corporate standards and local procedures. Interfaces with project teams to determine the change control approach for projects.
• Ensures that changes affecting more than one site are evaluated and approved through the multi-site change control process.
• Monitors the status of open changes, providing periodic reports and status updates on the overall performance of the change control systems.
• Defines appropriate effectiveness review criteria for technical changes. Administers periodic review process for documents. Securely archives GMP records; ensures their rapid retrieval when needed.
• Proposes and implements modifications to the change control systems to improve compliance, efficiency, and customer satisfaction. Provides timely support to continuous improvement initiatives across the site.

• Bachelor's degree and 5 years of CGMP experience
• 3 years of experience managing Change Control
• 2 years in a management role

• Bachelor's degree in Science or Engineering
• Familiarity with one or more of the following areas covered by technical change control
  • Biopharmaceutical manufacturing processes and equipment
  • Analytical equipment and methods
  • Classified environments and environmental monitoring programs
  • Critical utilities (e.g. WFI, clean steam, HVAC)
  • Process automation, preferably DeltaV
  • Proven track record of developing staff and managing a department.
  • Experience using TrackWise for electronic review/approval of changes M*

• Design and execute study protocols for in-process sample analysis.
• Work with cell culture and process development teams to define the requirements of the assays.
• Conduct data analysis, interpret and communicate assay results, and write study reports
• Coordinate the efforts among groups for sample analysis and analytic supports. Develop and present project proposals and progresses clearly in a well-organized manner, both orally and in writing.
• Attend development and scientific meetings to remain current with technology and regulatory guidelines
• Mentoring and coaching other junior member in the group

• Ph.D. or experienced M.S in life science related fields, with about 2-5 years (PhD) or 10+ years (MS) working experience, preferable in pharmaceutical or biotech industry.
• Hands-on experience in the development and implementation of Process Analytical Technology (PAT) methods for monitoring and profiling glycosylation .
• Experience with glycoform and glycan profiling using lectin and glycan based arrays, antibody-lectin sandwich assays.
• Experience with the development and implementation of automated high throughput platforms, such as Tecan and Caliper robotics.
• Experience with Capillary electrophoresis (CE), cIEF and HPLC based methods for glycoprofiling.
• Expertise in chromatographic instrumentation for on-line and in-line process analysis.
• Result-orientated with proven track record of success in managing and executing multiple projects simultaneously within a team environment.
• Experienced in documentation, project tracking and sample management.

• Set perating plans and priorities for production that are aligned with our delivery objectives.
• Ensure appropriate resources are in place to fulfill near term goals and commitments while building towards sustainable manufacturing excellence.
• Oversee, direct and support the Manufacturing group according to Genzyme policies and to achieve business objectives that will have a major impact on the success of the Corporation.
• Ensure strong coordination and alignment between Manufacturing and support groups.

• Ensure Manufacturing work practices are in accordance with the Genzyme - Sanofi Safety Programs.
• Establish departmental and individual goals and objectives in alignment with site goals and priorities.
• Identify the required resources and expertise, implement the appropriate team/departmental structures and establish the required processes and communications to enable department(s) to effectively deliver on all commitments.
• Develop strategies that ensure achievement of Manufacturing objectives that are consistent with the site's strategic direction.
• Develop and successfully manage to a production plan which supports a reliable product supply while upgrading the facilities and equipment and establishing capable, compliant manufacturing processes for area of responsibility.
• Active member of the Woburn Biosurgery Senior Leadership Team.

• resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
• Strengthen overall leadership and organizational capabilities in area of responsibility. Build and sustain a high performance team and ensure strong alignment and coordination with other functional groups at the site.
• Ensure team members achieve their potential and the teams meet their goals. Develop succession plans as applicable for department.
• Provide technical leadership to the Manufacturing team in area of responsibility and keep current on trends and new technologies and developments in area of responsibility.
• Manage departmental headcount and spending to budget.
• Participate in the development, revision and accuracy of the short range and long range production plans.
• Support and/or undertake long and short-term planning and supervision of projects that require cross-functional interaction, alignment and coordination.
• Lead the Manufacturing team in area of responsibility to excellent performance through a structured manufacturing system with the use of Operational Excellence tools: eg. LEAN-Kaizen; MDI.
• Manages employees, either directly or indirectly, who are involved in the scheduling, implementation, execution and/or maintenance of manufacturing processes and operations.
• Anticipate, identify and communicate risks in area of responsibility and across the site; participate in the creation of, support, and/or drive plans to manage and mitigate risks to the operations.
• Work with peers and counterparts across functions and sites to drive manufacturing excellence, share best practises and lessons learned to create industry-leading manufacturing of medicines and devices for patients.
• Continually track and maintain performance metrics. Routinely issue reports and engage staff and colleages to drive and continuously improve performance.

• Ensuring a safe working environment is maintained and reporting incidents/accidents to site leadership
• Managing and developing the performance of direct reports by setting clear "SMART" goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance
• Hiring and developing new employees, conducting performance appraisals and career development assessments for all direct reports

• Ensures coordination of batch record review, release packet compilation and performs finished product disposition in accordance with Genzyme SOP's, in-house product specifications and market regulations
• Ensures tasks are performed as outlined in overall department responsibilities in order to support the overall business need and supply chain demands as needed
• Develops, implements and maintains schedules and manpower requirements for assigned area
• Performs in‑depth evaluation and sign-offs of compliance documentation
• Ensure all projects are completed on schedule.

• Partnering with Manufacturing Managers, Distribution and Quality to ensure operations areas are inspection ready at all times
• Ensuring QA Packaging personnel are compliant with annual safety, Code of Conduct and CGMP training
• Ensuring QA Packaging group is up to date and maintains all required training related to GMP operations
• Managing and support product launches
• Leads deviation/investigation teams to resolution

• Provide recommendations for and implements process improvements
• Ensuring personnel identify and document events that deviate from procedure
• Supporting major and critical deviation investigations
• Manage on-time closure of assigned deviations and CAPA

• Contributing to continuous improvements of all packaging documentation (SOPs, PSs, OJTs) to ensure they are current, accurate, and clear. Managing staff responsible for reviewing and refining the current document periodic review process to ensure that all Packaging documents are accurate and revised as necessary

• Working collaboratively with inter-department and cross-functional teams to affect necessary changes in a timely and productive manner
• Owning and reporting RFT, record review and lot disposition timeline metrics.

M*

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.

• Performing record review necessary in ensuring the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor
• Conducting reviews of manufacturing processes to ensure compliance
• Conducting reviews of testing results in support of release of intermediates
• Assisting in deviation/nonconformance identification and resolution
• Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution
• Interpreting complex, explicit documentation to ensure quality standards and compliance
• Providing training to new employees

• Bachelor's Degree and 5 years Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent

• 7years experience in Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent
• Knowledge of CGMP regulations for US, EU and other markets
• Experienced with CGMP documentation review

• Industry bio-pharmaceutical experience
• Participated on project teams
• Provided guidance and training to QA team
• Strong computer, verbal and written communication skills
• Strong technical writing skills
• Effective time management, detail oriented, organizational skills, teamwork, and collaboration
• Practical experience with leading deviation/nonconformance identification and resolution
• Trackwise system experienced
• Management Inventory system experienced
• Experience with Quality database system, ie. Catsweb

• Ability to gown and gain entry to manufacturing areas. M*

• Experience with Trackwise and LIMS
• Strong troubleshooting ability

• Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

• Genzyme's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

• Strong leadership skills, driving accountability, compliance and efficiency
• Strong working knowledge of laboratory information management systems (LIMS).
• Experience in testing biologics
• Experience with Trackwise software

Special Working Conditions

Must be able to work with Sporklenz solution, which is used to sanitize equipment following SOP guidelines. M*

• Ensure strong Quality program for management of equipment and computer systems to ensure proper maintenance, calibration and conformance to regulatory standards
• Maintain procedures for accuracy and compliance.
  • Draft/revise/review/approve/ qualify/ validate/ transfer quality control test methods
• Ensure QC training curriculum designs and conduct training
  Assures the implementation of appropriate corrective actions in response to observations from Quality/ RA and System audits and/or third party assessments
  
  May provide oversight of groups responsible for technical leadership and guidance for the successful completion of major laboratory projects. This role will collaborate significantly with Analytical Development and Technical Service groups throughout and external to the corporation. Oversight of this Quality Control group will include and ensure:
  · Implementation of new quality control procedures
  · Transfer and development of new methods
  · Identifies deviations from QC methods and develops appropriate CAPA's
  · Recommends method improvements
  · Contributes substantially to the interpretation of results and subsequent impact to product/methods
  · Implementation and monitoring of personnel training related to new methods
  · Represents QC as the prime technical contact for laboratory projects
  · Identifies useful resources when applicable to meet laboratory objectives
  · Interacts with senior external personnel on technical matters requiring coordination between sites
  · Works independently with minimal to no supervision and direction
  · Work in compliance with CGMP's
  Practices safe work habits and adheres to Genzyme's safety procedures and guidelines

• Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

• Genzyme's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

• Strong leadership skills, driving accountability, compliance and efficiency
• Strong working knowledge of laboratory information management systems (LIMS).

• BS or MS degree in an Engineering discipline with a minimum of 12-15 years of progressive experience in the Biotechnology, Biopharmaceutical or Pharmaceutical industries

• Experience in leading and/or influencing multi-disciplinary global groups in a fast paced changeable environment
• Strong leadership, relationship management, and organizational planning and project management skills, in addition to technical knowledge
• Ability to influence sites, suppliers and colleagues into adopting "best practice" and a proven track record of building and growing "best in class" engineering teams
• Experience with Protein Purification and Chromatography equipment
• Experience in utility, facility, and equipment design and operation, as well as experience in cGMP manufacturing environments related to the design of equipment, to maintain sterile operations
• Excellent communication skills - verbal, written, listening and interpersonal with the ablilty to transfer knowledge to others portraying confidence to sites globally that you and your team are the experts and can deliver
• Good Supplier Relationship Management competence will be required
• Attentive to cultural sensitivities

• Place orders and enter into system under supervision
• Expedite open orders for the senior analysts
• Issue work orders as assigned
• Issue DRPs as assigned
• Issue SCARs as assigned
• Follow up on SCAR responses
• Assist with processing all rejects (send samples to suppliers, issue ITRs, follow up with other departments, etc.)
• Process shipping requests
• Process ITRs
• Assist in data gathering for monthly and quarterly presentations and meetings
• System maintenance
• Initiate eDCRs as required
• Initiate new item requests
• Assist with RFQs for any new items
• Assist in the creation of updating current specifications or initiating new ones

Basic Qualifucations

3 - 5 years industry experience

Preferred Qualifications

BS preferred

M*