Category Lifecycle Process Leader, Director of Procurement

Location:  San Francisco or Basel

Purpose

* This leadership role is responsible for leading a team in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable for design and delivery of the global category management process. 

* This leader has strategic accountability for the overall category management process for GPP, and must work with SRO leaders to ensure the process connects to the Source to Pay Process. 

* Key accountabilities include creation of a GPP category management tool kit and sourcing, supplier relationship management and governance processes.

* This leader will be responsible for creating and implementing an overall outsourcing process, strategic framework and governance management, which will require engagement with GPPLT and key business leaders. 

* This leader will be responsible for creating and implementing the Global eSourcing Program to establish eSourcing as way of working across GPP. 

* Drives sustainable savings and eSourcing process automation across affiliates, sites & GPP functions through partnership and collaboration.

 

Key Relationships

* GPPLT, and functional teams

* GPP business process owners

* Affiliate Procurement Leaders

* Global/Regional/Affiliate Finance Leaders

* IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 4-5 direct reports with total team of 10-15 employees and contractors .  Expand to 6 direct reports as Outsourcing Strategy and governance is established.

* Ensures the application of the GPP Category Management process is robust and established as a way of working through the Global Pharma Procurement functions. 

* Establishes and manages the Outsourcing process and strategy governance.

* Manages the connection through the coordination of the overall Procurement Processes of Category Lifecycle including Category Management, Contracting, Request to Pay and Master Data processes.   

* Manages the global category management process ensuring toolkit application and practice for both indirect and direct materials processes.  

* Manages process content and training materials for the category management and eSourcing processes.

* Establish and governs the Supplier relationship management and governance processes for GPP categories.

* Owner of the eSourcing Process:  Including improvements, system (IT Solution), Delivery of support and project portfolio.

* Sets up the eSourcing regional support model to support end to end eSourcing processes.

* Drives the adoption of eSourcing tool and processes globally.  

* Raises usage of eSourcing to increase effectiveness (deeper value) and efficiency (faster cycle time) through the use of eSourcing.

* Establishes and monitor global eSourcing targets in conjunction with savings targets.

* Identify eSourcing opportunities in conjunction with the GPP Categories.

* Manages sourcing project content and strategy including: project and bidding strategy, spend segmentation, recommendations for savings implementation, tender development (RFI, RFP, RFQ, auction formats) and managing multiple site project teams.

...

Lead process improvement projects at supplier sites as part of Supplier Management process, CMO light

Working with Genentech technology transfer teams lead:

•      Raw material transfers to CMOs

•      Raw material transfer from customers (insourcing projects)

Responsible for SAP management as an SME; provide updates and training of the group in the areas of Supplier and management of raw materials

Responsible for managing, negotiating and completing Quality agreements with suppliers

 

 Duties/Responsibilities:

 

·         Troubleshoot and direct the resolution of raw material Quality issues by fostering effective interdepartmental and cross-functional partnerships. Provide solutions to complex manufacturing, quality and negotiation problems.

·         Develop project plans and establish work priorities to meet targets and timelines.

·         Identify, design, and implement process and system improvements.

·         Manage department and cross-functional initiatives and activities.

·         Apply, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems related to chemical and component materials.

·         Serve as a technical subject matter expert (SME) in raw material and component requirements/specifications review and approval.

·         Serve as a trainer and train internal personnel (as needed) on SAP processes related to raw material management.

·         Collaborate and author department policies and procedures.

·         Be able to make decisions using a collaborative and cross functional process

·         Be able to apply good judgment and notify and escalate to Management potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Author, review and approve technical  reports as a result of projects

·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·         Set personal performance goals and provide input to departmental objectives.

·         Manage competing priorities and allocate, adjust, and optimize assigned department resources.

·         Perform any other tasks as requested by Management to support Supplier Quality oversight activities of chemical and component suppliers.

 

 

Technical Duties/Responsibilities:

Work with internal, CMO and customer groups and lead the tech transfer of raw materials. 

In partnership with GNE’s critical and standard suppliers ensure uninterrupted supply and internal raw material management groups perform the following technical duties.  .

•      Review Supply agreements and implement Quality Agreements with suppliers (as applicable)

•      Lead and or participate in Business and performance review meetings as applicable

•      Participate in supplier Risk Assessments, and  Supplier Analysis with Procurement (as applicable)

•      Lead  supplier site technical visits to review entire manufacturing processes related to manufacturing of chemicals, components and diluent materials

•      Partner with supplier on internal audits (when possible)

•      Perform supplier audits as needed

•      Write and review technical reports

•      Represent GNE  in customer advisory boards

•      Design and issue supplier business and Quality reports annually

•      SME representative in the SAP team

...

Planning Lead, Access Solutions Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Lead has an advanced knowledge base regarding Operational Quality and/or Healthcare Compliance and Privacy. This position is responsible assisting in the maintenance of all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, and the management of external business partners. Additional key responsibilities of this role are: quality and compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization as a subject matter expert on compliance related matters.

• Shares responsibility for monitoring, review and analysis of quality and general compliance for all Access Solutions operational entities. Relied upon for sound compliance guidance.
• Assists in the integration of quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations
• Assist in the management of outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• With limited oversight, develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as a team member for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on compliance matters of low to medium risk.

...

Sr. Planning Manager, Access Solutions  Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Manager has an advanced knowledge base regarding Healthcare Compliance and Privacy, or Operational Quality. This position is responsible for leading and maintaining all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, operational quality measures and the management of external business partners. Additional key responsibilities of this role are: compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization on compliance related matters.

• Extensive knowledge of organizational leadership and quality models, theories, tools methodologies and processes.
• Deploy change agent strategies in support of organization-wide continuous improvement efforts. Develop teams and participate on them in various roles
• Develop and maintain organizational focus on the importance of quality and performance excellence. Create quality policies and procedures in support of the strategic plan, and integrate those policies and processes into the tactics developed to support the strategic plan.
• Demonstrate management abilities in human resources, financial, risk, and knowledge management applications. Use effective communication methods in various situations to support continuous improvement efforts. Select and use appropriate tools and methodologies to plan, implement, and evaluate projects. Develop, deploy, and evaluate quality plans that can be used throughout the organization. Evaluate and recommend appropriate quality models or systems to implement in various situations.
• Integrate quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Manage, identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations to leadership the leadership/ senior leadership teams
• Manage outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• Develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as the subject matter expert for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on quality and compliance matters of medium to high risks.
• Represent the company as a primary compliance contact on concerns related to Access Solutions.

...

Senior Business Systems Analyst 

The Senior Business Systems Analyst will be responsible for supporting Strategic Pricing and Contracting Management (SPCM) systems planning and business process support, including contract development, contract administration and government price reporting operations. This role supports alignment of business processes and systems to provide accurate business monitoring, analytics and operational excellence across SPCM Teams.

The Senior Business Systems Analyst will be responsible for providing leadership on system projects including data analysis, user requirement gathering and documentation, business process documentation, and impact and gap analysis. They will serve as the subject matter expert for contract development, contract administration and government price reporting business processes, and the Veritas applications.

The Senior Business Systems Analyst will need to develop an understanding of the complex data environment in order to enhance standard reports, perform analysis and develop ad hoc queries and reports. This position requires the ability to retrieve data from multiple environments, identify trends, perform analysis and make recommendations. They may also lead or participate in developing data management strategies (including MCCO IT initiatives such as with the Channel, Customer and Contracting Performance, C3PI Initiative) and implementing accurate infrastructure for robust and hight-accuracy analytics. The position also requires strong written and verbal communication skills and an ability to collaborate with management and other functional groups within the Commercial organization. The data analysis will also support the SPCM Operational Excellence program that will be driven by existing and new metrics.

This position will be expected to have an up-to-date knowledge of the enterprise IT strategic direction and be able to influence IT system decisions that will be cost-effective, supportable and scalable. This will require strong leadership on projects and in the prioritization of the overall project portfolio, developing business cases and driving to maximize sIT ROI. This position reports to the Group Manager, Strategic Pricing and Contract Process and Technology.

...

Supervisor

• Manages the daily workflow, ensuring adequate coverage is available
  on a daily basis
• Performs ongoing analysis of existing operations and implements new functions and tactics as required
• Identifies trends/obstacles for distributor/vendor relationships and
  reimbursement activities
• Keeps current with applicable laws, regulations and policies that
  govern the conduct of activities and ensures staff members are
  adhering to these guidelines
• Maintains timely and effective communications with management
  regarding departmental issues
• Investigates and responds to customer complaints while concurrently
  instituting necessary improvements to avoid recurrence
• Ensures accountability for project timelines and SMART goals
• Provides staff with clear expectations, consistent direction, coaching and feedback
• Provides first line of support for escalated calls and external
  customer support issues
• Provides managerial support internally and externally
• Sets performance standards and conducts staff performance evaluations
• Identifies and communicates vision and strategy to team
• Identifies internal and external training requirements
• Works with internal business partners/stakeholders to understand
  their strategies and goals for integration into departmental goals and
  objectives
• Works with Planning Ops as appropriate to develop departmental budgets
• Creates, disseminates and directly manages special projects, audits
  and reports for team
• Identifies and undertakes a variety of special projects aimed at
  increasing effectiveness and finding efficiencies; also participates
  on cross-functional teams that help further operational success
• This position may require some travel and flexibility in work shift

...

Main Purpose of the Position:

• Provide day to day support to Non-Commercial Filling and Finishing Operations.

• Solve routine Manufacturing Quality Assurance and Product Release issues with broader scope and increased complexity following cGMP regulations and Genentech standards.  

• Perform assigned tasks and work to achieve company goals and department objectives.

• Perform routine Manufacturing Quality Assurance tasks to support product manufacturing and release.

Job Duties/Responsibilities:

• Follow company policies and procedures.

• Maintain a state of inspection readiness.

• Provide input to the development of personal performance goals and departmental objectives.

• Collaborate with Management to establish and meet targets and timelines.

• Independently manage competing priorities with limited instruction.

• Serve as a Quality representative on cross-functional and multi-site teams.

• Identify and recommend solutions to potential procedure, process and system gaps.

• Provide assistance to customers in support of departmental functions.

• Participate in the design and implementation of department and cross-functional initiatives.

• Apply basic theory and technical principles to address moderately complex problems.

• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

• Serve as a technical subject matter expert (SME) in support of department functions.

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:

• Evaluate and close complex, non-investigational discrepancies.

• Initiate discrepancy investigations as required.

• Draft and route discrepancy summaries to Discrepancy Management.  

• Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DMS).  

• Review and close completed evaluations and perform additional activities as warranted in the Discrepancy Management Systems (DMS).

• Review, edit and approve controlled documents.

• Assess and summarize complex process deviations.

• Collaborate with internal and external departments on MQA and Product Release projects and commitments.

• Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Management.

• Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.  

• Independently manage daily activities in order to meet standard lead times.

...

Under the direction of the MSAT Technical Services Manager, the Engineer I, Validation will be accountable for validation activities such as Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV) activities. Candidate will be able to collaborate with both plant and corporate organizations seamlessly, will be constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity and will able to provide the leadership necessary to maintain a high performance culture. Responsibilities: Develop, execute, and manage the detailed project plans and timelines for the execution of PQ/CV/PV/RV activities. Plan and execute PQ/CV/PV/RV activities. Prepare validation & change control, documentation, including protocols, summary reports, etc., for validation activities. Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts. Provide input into investigations with potential validation impact. Present and provide rationale for the validation program during periodic audits and regulatory inspections. Procure and manage contractor support for outsourced validation assignments. Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol. Support the change management system for validated equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a representative on cross-functional and multi-site teams. Lead and facilitate the development of formulation, filling, and packaging, area SOP’s and manufacturing documents as appropriate. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production....

Under the direction of the Technical Validation Associate Director the Senior Engineer will be accountable for leading teams and performing validation activities such as Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV). Able to collaborate with both plant and all network organizations seamlessly. Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity. Is able to provide the leadership necessary to maintain a high performance culture Responsibilities: Develop and manage the detailed project plans and timelines for the execution of validation activities. Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities. Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts. Present and provide rationale for the validation program during periodic audits and regulatory inspections. Procure and manage contractor support for outsourced validation and risk management assignments. Support the change management system for validated equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA. Lead and facilitate Risk Assessment sessions. Provide input into investigations and change control with potential impact to the site risk profile. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Mentor more junior validation engineers and train individuals on practices and procedures....

(Note: This description is not intended to be all-inclusive.)
Perform routine cleaning and custodial maintenance duties:
Execute required order of cleaning in a GMP environment.
Be able to execute all documentation required for cleaning in GMP environment.
Maintain floor surfaces (epoxy, Concrete, rubber tile, and sheet vinyl) by scrubbing, stripping, waxing, buffing, sweeping, wet mopping, and dry mopping these floor surfaces.
Operate floor cleaning machines, buffer, scrubbers and Zamboni.
Operate scissor lifts and fork lifts.
Maintain manufacturing areas by cleaning and disinfecting floors, walls and ceilings as required by cleaning documents.
Maintain stainless steel and windows in GMP areas.
Collect and dispose of garbage, including recyclable materials and some hazardous waste.
Move furniture as assigned when necessary.
Maintain bathrooms by cleaning and disinfecting sinks, mirrors, urinals, toilets, showers, and walls when necessary.
Perform miscellaneous tasks including cleaning venetian blinds, fans, humidifiers, windows, walls, drinking fountains, and garbage cans; polishing brass and stainless steel; replacing light bulbs when necessary.

Perform outside maintenance tasks:
Perform snow shoveling and sweeping of sidewalks and stairs when necessary.
Apply deicer to sidewalks and stairs when necessary.

...

Main Purpose of the Position: Provide direct manufacturing Quality Assurance support to Production (Inspection, Packaging, Aseptic Operations) in a GMP environment. Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. Assure compliance with cGMP regulations, Roche / Genentech standards, and applicable Regulatory Guidelines. Solve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Genentech standards. Perform assigned tasks and work to achieve company goals and department objectives. Job Duties/Responsibilities: Follow company policies and procedures. Maintain a state of inspection readiness. Provide input to the development of personal performance goals and departmental objectives. Meet assigned targets and timelines with minimal supervision. Prioritize assigned tasks within a fast paced environment. Participate in process improvement and system design teams. Provide assistance to customers in support of departmental functions. Work with colleagues to maintain cross-functional and cross-site process and procedural consistency. Receive specific instruction and work independently to complete tasks. Apply basic theory and technical principles to address routine problems. Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Sign documents for activities as MQA as described by Genentech policies, procedures and job descriptions. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Perform any other tasks as requested by Management to support Quality oversight activities. Technical Duties/Responsibilities: Perform Inspection and Packaging AQLs. Perform Line Clearances for Inspection, Packaging, and Aseptic Operations areas. Initiate and close discrepancies and child records as required. Review batch records in the Inspection, Packaging, Aseptic Operations areas. Perform Assessor and Evaluation activities in the Discrepancy Management System. Interact with interdepartmental contacts on discrepancy assessment and resolution. Provide Quality oversight to internal and external customers. Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support Quality process improvement initiatives. Support the execution of departmental deliverables assigned by project teams. This is a SWING shift position: Monday, Tuesday, Wednesday, Thursday, and Friday – 4:30pm to 1:30am...

Main Purpose of the Position: Solve a wide range of challenging issues that impact multiple functions by managing change records in accordance to cGMP regulations and Genentech standards. Manage staff performing a variety of routine and complex change control activities to meet cGMP regulations and Genentech standards. Perform assigned tasks and manage performance and development of direct reports to ensure achievement of organizational and department goals objectives. Job Duties/Responsibilities: Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities. Set operational objectives for staff. Follow company policies and procedures. Help maintain a state of inspection readiness. Lead and participate in improvements to Quality operational policies, plans and procedures. Manage routine department activities and complex Quality initiatives. Ensure completion of activities and initiatives on time and within budget. Serve as the Quality representative on cross-functional and multi-site teams. Identify, design, and implement process and system improvements. Lead and participate in the design and implementation of department and cross-functional initiatives. Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems. Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Serve as a technical subject matter expert (SME) in support of department functions. Train personnel on relevant business processes. Be accountable for behaviors as described in Roche’s Core Competencies. Technical Duties/Responsibilities: Function as a Change Controller by assessing, reviewing, approving and closing change records. Ensure the management of lot release restrictions imposed by system, process, method and equipment changes. Author, edit, word process, and release controlled documents relating to Quality Systems. Provide training to new employees and internal customers on policies and procedures for the Change and Document Control systems. Facilitate and contribute to cross-functional change management forums. Recommend change control strategies that have minimal impact of validated systems and qualified equipment. Lead business process improvement and process redesign initiatives. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support periodic audits and regulatory inspections. Develop and implement systems to ensure inspection readiness. Provide data for departmental performance metrics. Serve as a Quality representative on cross-functional and multi-site teams. May be required to support other Quality Systems & processes such as Document Management, CAPA, Product Complaints, Annual Product Reviews. Support internal and partner audits, and health authority inspections....

Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
Perform safety and housekeeping audits as required.
Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
Supporting the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of Genentech systems as required.
Perform training of other Technicians.
Assist in the development of plant SOP's and training materials
Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
Perform material handling in the plant as required.
Perform preparation of sterile components.
Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
Perform bulk thaw, dilution, and formulation operations.
Performing manual inspection of empty vials and filled product with a focus on quality and efficiency.
Conduct environmental monitoring activities in the manufacturing areas as required.
Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs,
Process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Perform cleaning and housekeeping duties as required....

Responsible for implementing and maintaining the validated state of equipment, IQ,OQ,SIP and cleaning validation programs. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol
report closure for the site. Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing. This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• Manage protocol execution, perform data review and manage deviation resolution.
• Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
• Strong understanding of commercial production environment and requirements.
• Evaluate and audit the current validated status of equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
• Participate in cross-functional team meetings and where required, lead/facilitate meeting.
• All employees with jobs that require access to the Warehouse must be able to pass the
• Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

...

Essential
• Responsible for training staff members and employees in the areas of cGMP Training, technical skills, safety, Performance and Best Practices. Responsible for Training Logistics and the Strategic development of organization's technical capability .
• Manages internal technical and compliance issues.
• Manages internal review of all training programs, policies, and practices to ensure compliance
• Coaches the management team to develop and implement viable operational processes that are robust and scalable.
• Ensures training and performance improvement programs are effective and utilizes constrained resources efficiently.
• Prepares and is proactive in overseeing compliance internally to ensure compliance with FDA and EU regulations.
• Oversees GMP training records and inspection preparation efforts, represents training as a quality system to regulatory agencies.
• Remains current in industry and sector best practices and approaches.
• Provides input and oversight of the budget for TrainingiInstructional design programs and third party delivery of training programs.
• Assists in selecting and overseeing the work of training consultants, contractors, and vendors
• Promotes a safety culture that support continuous improvement in the EHS management system through active communication and functional area participation in site safety teams ensuring the safe and efficient operation of assigned functional areas and activities. Fosters a positive safety culture in which no one gets hurt....

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.

 

Job Responsibilities

Essential

• Provide coaching and training on best practices and compliance to SOPs.

• Prepare solutions for the production process.

• Participate in continuous operational improvement.

• Provide reports to management summarizing goal unit attainment.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Understands the theory, concepts, and regulations behind biopharm technology and processes. 

• A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.

• Anticipates potential problems and takes preventative action.

• Requires judgment to know when it is necessary to consult with supervisor and/or support groups. 

• Understands how own actions impact others and uses this information in decision-making.

• Operate systems that clean and sterilize tanks and filtration systems. 

• Prepare solutions for the production process.

• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).

• Trouble shoot equipment and process problems.

• Comply with safety requirements, cGMP, SOP and manufacturing documentation.

• Use of automation to perform production operations.

• Provide support to Manufacturing to meet production demands.

• Operate automated systems for equipment operation.

• Assemble and prepare equipment for production.

• Exhibit detail oriented documentation skills.

• Communicate effectively and ability to work in a team environment.

• Exhibit professional interpersonal skills.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.

• Operate and clean fixed tank and filtration systems.

• Operate large scale column chromatography systems.

• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.

• Perform CIP and SIP.

...

Responsible for producinginnovative biotherapeutic medicine by interfacing with highly automatedproduction systems and controls in cGMP manufacturing environment, and maintainareas in high state of inspection preparedness. Operates production equipment for cell culture or purification that mayinclude culture growth, process monitoring, sampling, harvesting, purification,formulation, freeze thaw and transfer.  Performsmedia/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatoryrequirements utilizing current Good Manufacturing Practices (cGMP) and StandardOperating Procedures (SOP).  Responsible for being proficient in two or morefunctional areas and applies expert knowledge of mechanical, scientificprinciples, processes and biopharmaceutical processing equipment.

• Provide coaching and training on best practices and compliance toSOPs.
• Prepare solutions for the production process.
• Participatein continuous operational improvement.
• Providereports to management summarizing goal unit attainment.
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• Understandsthe theory, concepts, and regulations behind biopharm technology andprocesses. 
• Astrong knowledge of at least one manufacturing department with an understandingof process impact of other areas.
• Anticipatespotential problems and takes preventative action.
• Requiresjudgment to know when it is necessary to consult with supervisor and/or supportgroups. 
• Understandshow own actions impact others and uses this information in decision-making.
• Operate systems that clean and sterilizetanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check allcalculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and processproblems.
• Comply with safety requirements, cGMP,SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a teamenvironment.
• Exhibit professional interpersonal skills. 
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• All employees with jobs that require access to theWarehouse must be able to pass the Transportation Security Administration (TSA)Security Threat Assessment (STA).
• Follows established safety and environmentalguidelines and procedures for all work performed.  Immediately reports safety and environmentalincidents including injuries, illnesses, near misses, and safetysuggestions.  Fosters a positive safetyculture in which no one gets hurt.
• Operate fermenters, centrifuges, otherharvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operatingcleaning, set up, and maintaining 20L batch reefed fermenters; inoculating andmaintaining spinner seed cultures using aseptic techniques, maintaining cellbanks; and performing general seed lab operations.
• Perform CIP and SIP. 

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Summary:

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

• Cell Culture Manufacturing (CCM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations.
• Purification Operations Group (POG): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems.
• Centralized Manufacturing Services (CMS): Provide support to Manufacturing and Quality Control to meet production demands.  Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean, kanban, and deliver lab ware, glassware, parts and equipment; perform weighing and dispensing of components; handle and aliquot hazardous materials;  Provide quality materials and service to our customers.

Job Responsibilities:

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
  

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The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for downstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

 

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as downstream frontline representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in the following areas;

·        Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·        Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

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The Position: Accountable for managing a multi-discipline technical group responsible for performing a variety of routine and complex activities under cGMP regulations and standards. The team’s primary responsible is providing technical support for upstream manufacturing operations to ensure reliable delivery of drug substances to the global supply chain. Manage performance and development of direct reports to achieve organizational and department goals in a productive work environment. Develop solutions to complex issues and key Technology initiatives. Establish work priorities and timelines in alignment with project and department needs. Form productive relationships with individuals and groups across the Vacaville site including but not be limited to; Manufacturing, Science and Engineering groups, Validation, Facilities, and Quality Assurance.

Responsibilities and Job Duties: The successful candidate will manage and administer all aspects of personnel performance and staff development. This includes selection, hiring, and training of personnel on company and department policies, systems, and processes. Manage and communicate compensation related information per company guidelines. Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year, including workload balancing. Recommend and implement improvements to Technology policies, plans, and procedures. Manage routine department activities and Technology initiatives, ensuring completion of activities and initiatives on time and within budget. Serve as USFL representative on cross-functional teams and at senior level meetings. Oversee and direct timely resolution of complex issues through effective interdepartmental and cross-functional partnerships. Clearly and effectively communicate and present complex ideas and concepts to all levels within the company. Establish and communicate strategy, vision and direction for their team.

 

Technical Responsibilities: The successful candidate will be responsible for managing a diverse team comprising a variety of technical disciplines and skills levels, including Automation, Manufacturing Sciences, Process Engineering, and Validation.  The candidate will oversee technical cross-training efforts, act as a mentor, and provide technical career guidance. Provide technical leadership while fostering teamwork in a GMP environment across functional and organizational boundaries. Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution. The candidate must effectively manage their team in two areas;

·         Immediate resolution of emergent issues including troubleshooting process, equipment and system malfunctions or failures on a 24/7 basis. Daily process monitoring and analysis of manufacturing data, support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation.

·         Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of CAPAs. Support and/or lead a variety of capital and expense projects ranging from design, implementation, and startup. Develop solutions to complex problems which may require highly innovative and ingenious approaches.

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