If you are interested in working for Repligen but do not see a current opening that matches your skill set, you may submit a resume for general consideration. AppLY
WALTHAM, MASSACHUSETTS, USA
The successful candidate will be responsible for providing Process/Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. Provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Support the review and release of the XCell™ ATF single-use product line.
- Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectations (e.g., Quality System Regulation, ISO standards, ASME BPE, etc.). Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
- Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
- Ensure the development and validation of appropriate test methods for product and process performance
- Ensure active and thorough investigation of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints)..
- Support the XCell™ATF single-use product line through the review of batch records and lot release.
- Additional responsibilities involve review of supporting data for production activities, such as, environmental monitoring, Reverse Osmosis Deionized water, cleaning logs, and controlled temperature chamber logs. This individual will also assume various administrative functions, such as, label generation, binding, and filing of production records
- Perform batch record review; to include production, monthly RO/DI, weekly Environmental Monitoring records, and weekly/monthly logs
- Identify process deviations, corrective actions
- Identify out of trends and out of specifications for product
- Verify labels generated by Document Control
- Bind and file completed batch records
- Effectively utilize Lean and Six Sigma methodologies as appropriate to achieve optimal results
- At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).
- Understanding of basic chromatography, fermentation and purification (production and lab scale) is required for this position
- Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
- Minimum 5-7 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent
This position is for a Manufacturing Associate in the Repligen XCell ATF manufacturing group. Operator will be responsible for all aspects of manufacture, including electronic controller assembly and testing, pneumatic and vacuum solenoid valve assembly and test, system pressure and vacuum testing, system flow calibration, product evaluation, and software testing. This person will also be responsible for documenting all work in production batch records; tracking data in Microsoft Excel and creating SOP’s in Word; operation of laboratory equipment (including pumps, Multi-meters, power tools, hand tools, pressure tanks, and various gauges/sensors) and operation of manufacturing equipment.
- Operates and maintains production equipment as it relates to manufacturing operations
- Maintains records to comply with regulatory requirements. Documents all work on batch records according to Good Manufacturing practices. Performs batch record review as required by Production management
- Completes ISO9001 QMS documentation, including Batch Records, Forms, Deviation reports, Failure Investigations and Change Controls
- May be involved in identifying root causes to production issues
- Responsible for completion of any Repligen bioprocessing manufacturing tasks related to meeting production goals
- Able to work independently, to meet all manufacturing objectives
- May be asked to participate in other manufacturing operations, as required by management such as inventory control, packaging, and assisting in development activities
- Minimum of an A.S. in Technical discipline (e.g.EE Technology, Mechanical Technology, or Engineering, etc.) and 3-5 years relevant experience
- Experience and/or willingness to work in a biopharma manufacturing clean room setting is a must
- Candidates with electro mechanical aptitude preferred
- The ideal candidate would be conscientious and self-motivated with a proven track record as a quick learner
Looking to get your foot in the door in a career in marketing? We’re searching for a Marketing Intern who is proficient in Microsoft Word and PowerPoint to help rebrand and layout collateral and presentations. Graphics experience a plus!
- Use Microsoft Word to rebrand and layout existing collateral into new template
- Use Microsoft PowerPoint to layout existing presentations into new template
- Assist in some database clean-up, and other Marketing functions as needed
- High proficiency in Microsoft Word and Microsoft PowerPoint
- Laser-focus attention to detail
- Copywriting and/or graphics experience a plus
We have an exciting opportunity for an experienced, hands-on business systems analyst to join a rapidly growing systems team. This is the ideal position for the candidate to demonstrate their knowledge, and drive process change in the growth of the company. The Business Systems Analyst works with the business units to understand their needs, with a specialty and focus on the business’ needs in relation to information technology. They will work to understand the overall business need, create a business case, define the technological requirements using various approaches, then decompose the requirements into a detailed implementation plan, and be a key part of the implementation team.
This position will report to the Business Systems Architect and have a key role in the expansion and maintenance of Salesforce.com, ERP applications, current associated systems, and future expansion. The ideal candidate for this Business Systems Analyst position will have demonstrated experience working with ERP systems. They will also excel in managing a diverse portfolio of IT business systems related projects from conception to completion, ensuring adoption, and fostering participation from all levels of the company.
This is a temporary role covering a maternity leave. There is a possibility it could become permanent.
- Assess technology needs of company business units
- Work closely with business units, department heads, and application users to establish moreefficient ways to utilize business systems
- Develop business process models and workflows
- Involved in business system implementation such as core financial and accounting, supply chain management, customer relationship management, and business reporting
- Recommend, develop, or modify reporting and electronic workflows based on user needs, requests, or the candidate’s suggestions of best practice
- Integrate data between disparate systems
- Solicit training needs and train application users through group and individual mentoring in test and live environments
- Provide tier I support, conduct item reconciliations and system troubleshooting as requested by users and following through to resolution
- Accomplishes company goals by accepting ownership for new and different requests; exploring opportunities to add value beyond job requirements
- Requires 4-6 year of experience in an ERP business analyst role
- Salesforce.com experience is a major requirement
- Experience in requirements gathering and documentation of business needs
- Experience in a business process modeler (i.e. – Visio)
- Demonstrated experience with Business Systems (ERP, CRM, Quality, Manufacturing, HR)
- Preference for ERP Supply Chain and Manufacturing module experience
- IT Project Management experience preferred
- Expert level experience with Windows, Microsoft Office, and workflow tools
- Experience with some or all of the following: SQL Server, stored procedures, eOne SmartConnect, Extender Enterprise, Crystal Reports, Management Reporter, SmartList Builder, SSRS, Crystal Reports, Cognos, Hyperion, Tableau, Office 365 SharePoint, SharePoint Designer, or SharePoint Foundation
- Previous system implementation experience required in a variety of business systems
- A broad spectrum of experience in business systems that can be applied to future system implementations; workflow improvements, reporting and forecasting
- Independently problem-solves, interprets data, proposes improvements, and plans
- Able to interact with all levels of personnel in a professional and engaging manner
- Maintains the highest level of professionalism under pressure
- Ability to use independent judgment when needed
- Excellent communication skills
- Bachelor’s degree in Management Information Systems, Business Administration, or equivalent experience
SHREWSBURY, MASSACHUSETTS, USA
No current openings
The successful candidate will be responsible for serving as the customer advocate and ensuring satisfaction in product based transactions and communication with Repligen. She/he will maintain direct contact with global customers before and/or after the sale from order management to fulfillment, delivery and post-delivery support of the account. The Customer Service team is also responsible for all customer inquiry requests for Repligen such as vendor/supplier documentation support, technical product information and the management of customer complaints required for our ISO Quality Management system.
- As a member of the customer service team, provide best practice customer service and support of Repligen’s global customers:
- Product and service information for TangenX products
- Order management and invoicing (from receipt to post-delivery support)
- Preparation of export documentation required
- Complaint management and resolution with Product Management, Quality, Manufacturing and Supply Chain teams
- Triaging inquiries into internal cross-functional teams for resolution
- Execute case management administration through salesforce.com
- Perform order execution in the Dynamics system
- Facilitate the launch of the complaint process with customers by providing the documentation and escalation required internally for resolution
- Partner with product management, supply chain and distribution to ensure the downstream process of pick, pack, ship and deliver is executed to the customer’s expectation
- Coordinate with the finance team to ensure accurate order invoices and timely receivables
- 2+ years’ experience in global customer service/order management with a strongly developed commitment to client services
- Experience working with ERP systems, experience in Salesforce.com a plus
- Life Sciences industry experience preferred
- Global experience in customer service and order management; with strong cultural awareness
- Understanding of import/export/trade compliance requirements globally
- Understanding of revenue recognition requirements for a publically held company
- Experience in an ISO9001 quality system a plus
- Excellent attention to detail and strong organizational skills
- Strong analytical and problem solving skills
- Excellent verbal and written communication skill required for internal and external purposes
- Demonstrated passion for providing excellence in the customer experience
- Bachelor’s Degree or equivalent required
Repligen acquired TangenX™ Technology in Shrewsbury, MA in December 2016. TangenX offers a complete line of both single use and reusable tangential flow cassettes that complement our product portfolio.
We have an opening for a Quality Assurance Manager at the TangenX site in Shrewsbury, MA.
- Provide and lead quality compliance through training; foster a quality-oriented culture
- Manage the Quality Documentation system and archival process, maintain employee training forms
- Manage the daily Quality activities of finished membranes and cassette products from incoming raw material release through batch record review and release of finished goods.
- Lead/administer audits of systems, processes and products to ensure compliance with ISO and customer requirements and compliance to the Quality System. Participates in and/or hosts third party audits
- Maintain critical supplier qualification and evaluation program including annul critical supplier evaluations
- Monitor the complaint handling process through maintenance of complaint handling requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable
- Set up and oversee product related deviations, CAPAs and participate in development of corrective action plans
- Coordinate/track/drive closure of audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner
- Design, compile, analyze, trends and issue QA performance metrics reports. Present summaries to the senior management team during Management Review
- Review and or approve IQ/OQ and Validations of critical processes and equipment
- Manage and develop QA staff members; plan and implement QA resources to support quality related activities
- Write and implement standard operating procedures and work instructions for QA actions
- Write and revise purchase specifications for critical raw materials
- Complete customer questionnaires, surveys, and review customer Confidentiality and nondisclosure agreements
- Issue copies of quality certificates upon customer request
- BS/BA degree
- 5-7 years related QA and Quality Management Systems experience required
- Strong understanding of ISO 9001 requirements is required
- Able to lead a group and work independently, without instruction
- Experience leading Quality audits both internally and externally is preferred
- Excellent cross-functional team participation skills
- Highly organized and detail-oriented
- Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software
No current openings
This role reports directly to the Corporate Controller and is a proven professional, responsible for all technical and accounting operations for Repligen’s German site. This includes developing people, improving processes and controls and working effectively, cross-functionally, in a rapidly changing environment.
The Site Finance Manager works closely with all parts of the German organization and is responsible for the financial close, financial reporting, revenue recognition, accounts receivable, accounts payable, payroll, etc.
- Manage monthly, quarterly and annual close processes
- Help implement and refine SOX controls at the Site
- Perform revenue, inventory and cost accounting work, in partnership with local customer service and operations teams
- Serve as the primary interface for external auditors in connection with financial reviews, attest audits and internal control reviews, including supporting schedules/reconciliations
- Partner with third party provider on tax provisioning, filings, payments, etc. to ensure compliance with local and national tax jurisdictions
- Work closely with financial planning and analysis team on reporting efforts related to budgeting and forecasting
- Monitor and ensure the timely identification of evolving accounting guidance and potential impacts on the company. Partner with operations to develop and implement operational changes, as required
- Perform special accounting analysis and projects, as requested
- Bachelor’s degree in Accounting preferred
- Strong knowledge of U.S. GAAP
- Fluent in English
- Multi-national company experience preferred
- Experience implementing SOX controls preferred
- Ability to organize and manage multiple priorities; deadline oriented
- Skill in problem analysis and resolution
- Excellent verbal and writing skills
- Hands on work ethic with strong attention to detail
Repligen is seeking a highly motivated and experienced salesperson whose primary role will be to sell an expanding portfolio of highly differentiable, high-value products and flexible solutions that address critical steps in the production of biologic drugs - principally monoclonal antibodies - to new and existing Biopharmaceutical customers across a territory spanning the North of Germany, the Nordic Countries and Baltic states.
The ideal candidate will demonstrate a high level of motivation to succeed, highly developed sales and territory management skill sets in the Life Sciences sector, and is now looking for the next challenge at a rapidly evolving and innovative bioprocessing-focused life sciences company. Reporting directly to the Sales Director, Europe, this is a home office based role.
The ideal candidate will have an excellent working knowledge of English and German.
- Drive sales process to meet or exceed sales and profitability targets
- Promote and sell a portfolio of upstream, downstream and single use products; be able to articulate key differentiators and value proposition of company products
- Develop and execute a territory management plan
- Conduct sales negotiations with technical and planning departments
- Establish and maintain Strategic Key Account relationships
- Develop new target accounts across the territory
- Provide accurate and timely sales reporting and forecasting with a market leading CRM tool
- Maintain contact with key market infrastructure partners and identify new sales and business opportunities
- Be the customer and market advocate to the internal organization
- Interface with Business and Market Development to ensure that appropriate product, market and competitive information is shared in an accurate and timely manner
- Support the development of sales collateral
- Provide Manufacturing and QA/QC operations with timely information to support forecasting, customer complaint handling and facility audits
- Execute all aspects of field sales activity to include customer visits, technical presentations and laboratory demonstrations
- Attend, manage and follow up on trade show activities
- A minimum of a BSc degree in a scientific discipline or equivalent
- A minimum of 8+ years of experience in the biopharmaceutical or life science industries. A strong understanding of Cell Culture and filtration is a priority. However, additional skills and understanding and downstream processing would also be beneficial
- Proven sales track record and key account management experience
- Proven ability to build mutually beneficial trusting relationships with customers, suppliers and partners
- Strong analytical and forecasting skills
- Willing to travel extensively throughout the territory
- Attention to detail, excellent verbal and written communication skills, good analytical and problem solving skills, and strong organizational skills
We are seeking a Field Application Scientist to technically support the TangenX® product line in Europe. This individual will use their knowledge of downstream process development, filtration and bioprocess manufacturing to support customers and our sales team in pre- and post-sales opportunities.
The successful candidate will also work closely with Repligen colleagues including Sales Account Managers, Product Management, Quality Assurance, and Development Scientists/Engineers to ensure our products continue to serve the evolving needs of our customers in the bioprocessing industry.
This is a field based position requiring travel within Europe and occasionally outside of Europe.
- Work in coordination with the Repligen Sales team and Product Management to provide pre and post-sales support to customers for the TangenX® TFF product line. This will include responding to customer requests for technical support, giving technical seminars, performing product demonstrations, providing on-site/in-lab support, troubleshooting and assisting with the execution of voice of customer surveys.
- Develop and execute project plans to meet customer needs using Repligen technologies.
- Provide knowledge and customer feedback to Product Management and R&D for the continuous improvement of Repligen products.
- Contribute to applications data and collateral generation by liaising with R&D.
- A Bachelors degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field.
- 5+ years’ experience working in a downstream purification discipline in a development or manufacturing setting in the bioprocessing industry. Relevant experience in the development of harvest clarification and UF/DF unit operations. Working knowledge of cGMP requirements.
- Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required.
- Strong problem solving and analytical skills.
- Ability to manage yourself and work independently to achieve defined goals.
- Ability to work well within a global, cross functional team.
- Must be willing and able to work flexible hours to accommodate client schedules.
- Up to 50% travel within Europe and occasionally outside of Europe.
We are seeking a Field Application Scientist to technically support the XCell™ ATF product line in Asia. This individual will use their knowledge of cell culture process development, filtration and bioprocess manufacturing to support customers and our sales team in pre and post sales opportunities.
The successful candidate will also work closely with Repligen colleagues in the US and locally and with distributors in the region. The candidate will interface with Sales Account Managers, Product Management, and Service to ensure our products continue to serve the evolving needs of our customers in the bioprocessing industry.
This is a field based position requiring domestic travel. It is preferred that the candidate is based in Shanghai.
- Work in coordination with the Repligen Sales team, local distributors and Product Management to provide pre and post-sales support to customers for the XCell ™ ATF product line. This will include responding to customer requests for technical support, giving technical seminars, performing product demonstrations, providing on-site/in-lab support, troubleshooting and assisting with the execution of voice of customer surveys.
- Develop and execute project plans to meet customer needs using Repligen technologies.
- Provide knowledge and customer feedback to Product Management and R&D for the continuous improvement of Repligen products.
- A Master’s degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field
- 5+ years’ experience working in a cell culture discipline in a development or manufacturing setting in the bioprocessing industry. Working knowledge of cGMP requirements.
- Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required; Strong English speaking skills
- Strong problem solving and analytical skills
- Ability to manage yourself and work independently to achieve defined goals
- Ability to work well within a global, cross functional team
- Must be willing and able to work flexible hours to accommodate client schedules
- 50% domestic travel with limited international travel