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

This position will function in Repligen's OPUS Column Packing groups. Cross training into other departments may be required based on the changing needs of the department.  The successful candidate will play a key role in ensuring that the department's production and quality goals are met.  Applicants must have strong technical knowledge and problem solving skills.  Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.

Experience working in a classified cleanroom, and knowledge of GMP/ISO/document controlled processes would be beneficial. Attention to detail, and the ability to work in a team environment are essential. Ability to read engineering drawings and be familiar with process control software is also highly desirable. Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime (including occasional weekends).

Responsibilities:

  • Cleaning, assembly, packing and testing of large scale chromatography columns in a classified cleanroom environment
  • Analysis of chromatography column performance
  • Buffer preparation
  • Equipment and component cleaning and preparation
  • Execution of production batch records and validation protocols
  • Timely and accurate completion/review of production documentation and maintaining of laboratory notebooks, summarizing results, tracking data in Microsoft Excel/Word
  • Compliance with all aspects of Repligen's IS09001Quality Management System
  • Entry of  in-process data into trending databases
  • May be required to cross train into other departments based on the needs of the company

Qualifications: 

  • BS degree in Chemical Engineering or a related field preferred and 5+ years’ experience in Biotech manufacturing.  Candidates without BS degree will be considered with 7+ years' experience in Biotech manufacturing
  • Experience in low pressure large scale column chromatography is preferred
  • Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment.
  • Excellent organizational and communications skills
  • Must be resourceful and self-motivated and a team player

This position will function in Repligen's OPUS Column Packing groups. Cross training into other departments may be required based on the changing needs of the department.  The successful candidate will play a key role in ensuring that the department's production and quality goals are met. Applicants must have strong technical knowledge and problem solving skills.  Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.

Experience working in a classified cleanroom, and knowledge of GMP/ISO/document controlled processes would be beneficial. Attention to detail, and the ability to work in a team environment are essential. Ability to read engineering drawings and be familiar with process control software is also highly desirable. Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime (including occasional weekends).

Responsibilities:

  • Cleaning, assembly, packing and testing of large scale chromatography columns in a classified cleanroom environment
  • Analysis of chromatography column performance
  • Buffer preparation
  • Equipment and component cleaning and preparation
  • Execution of production batch records and validation protocols
  • Timely and accurate completion/review of production documentation and maintaining of laboratory notebooks, summarizing results, tracking data in Microsoft Excel/Word
  • Compliance with all aspects of Repligen's IS09001Quality Management System
  • Entry of  in-process data into trending databases
  • May be required to cross train into other departments based on the needs of the company

Qualifications: 

  • BS degree in Chemical Engineering or a related field preferred and 3-5 years’ experience in Biotech manufacturing.  Candidates without BS degree will be considered with five plus years' experience in Biotech manufacturing
  • Experience in low pressure large scale column chromatography is preferred
  • Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment.
  • Excellent organizational and communications skills
  • Must be resourceful and self-motivated and a team player

APPLY

We are seeking a self starting, enthusiastic candidate with extensive knowledge of Quality Systems in a paper based environment. The incumbent will redevelop Quality Systems to streamline process and drive efficiencies in support or the current rate of growth as well as the changes required to meet the demands of the new revision of the ISO standard. The incumbent will also be responsible for maintaining the day to day activities for product manufacture, test and release including deviation support, OOS support and root cause analysis.

Responsibilities:

  • Maintain compliance to ISO 9001 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation.
  • Provide direct oversight to Quality Control daily routines and training initiatives.
  • Serve as the Management Representative to the ISO 9001 registrar.
  • Represent Quality during New Product Development projects.
  • Develop, Monitor and Compile Quality metrics as inputs for management review meetings with the Senior Management team.
  • Maintain internal and external (customer and vendor) audit schedules and develop and mentor auditor teams.
  • Implement new risk based strategy for overall Quality compliance across the organization and in support of the 2015 ISO standard.
  • Review and approval of validation plans, deviations, root cause and corrective action plans prior to implementation.
  • Assists with OOS investigations, OOT investigations and NCMR investigations.
  • Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews.
  • Up to 10% travel to assist with external audit requirements

Requirements:

  • Bachelor’s degree in Engineering, Biology or Chemistry degree required.
  • Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required.
  • Minimum 4 years of experience mentoring and supervising direct reports.
  • Strong attention to detail.
  • Enthusiastic, team player, collaborative across all departments to achieve the common goals.
  • Lead auditor certificate preferred.
  • Experience with LEAN implementation strongly preferred.
  • Demonstrated ability to foster a Quality Culture across the organization.

APPLY

The XCell™ ATF Commercial Project Manager plans and manages the delivery of commercial scale XCell™ ATF systems. The position provides direction to the project team and works closely with internal and external business partners or customers to ensure on-time, on-budget and in-spec deployment of the products in accordance with Repligen’s business practices

Responsibilities: 

  • Responsible for managing XCell™ATF commercial system orders from inquiry-to-design/build-to-delivery, the Project Manager generates manages orders, tracks progress, and communicates status to customers and internal project team
  • Responds to and develops project objectives by reviewing end-user RFQ/RFP, URS and FRS documents and coordinates design modifications based on approved project requirements
  • Maintains project schedules by actively participating in and monitoring project progress; manages and controls project plan by reviewing design and specifications; plans and schedules changes; recommends actions and coordinates activities with multiple functions including Sales, QA, Manufacturing and Supply Chain
  • Responds to technical questions related to hardware engineering, quality, design, applications and system operation. Conducts training on new systems and components.

Qualifications: 

  • 5-7 years’ experience in project management related to  systems design, assembly, testing and operation in a multidisciplinary setting
  • Analytical skills and solid understanding of the main principles of engineering attained within an Engineering discipline, including but not limited to B.S. in Mechanical or Chemical Engineering, or a similar engineering discipline
  • Strong written and verbal communication skills as needed to frame customer requirements and provide internal and customer updates
  • Bioprocessing experience preferred including pharmaceutical/biologics commercial manufacturing, equipment/process engineering, etc. Process development/laboratory applications experience is a plus. Basic understanding of bioreactor and cell-culture operations is desirable
  • Desirable qualifications: Equipment/System Design training or experience, customer-facing experience, Quality mindset,   P&ID mark-up etc.
  • Willing to travel globally up to 25% 

APPLY

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 customers before and/or after the sale from ordering and order entry to fulfillment and delivery. They will also be responsible for customer calls seeking technical product information and handling customer complaints.

Responsibilities: 

  • As a member of the customer service team, provide seamless customer service and support of Repligen’s global customers:
    • Product and service information, pricing quotations
    • Order management (from receipt to post-delivery support)
    • 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 Great Plains Dynamics ERP 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
  • Support field sales and coordinate logistics for marketing activities such as tradeshows and conferences

Qualifications: 

  • 2+ (4+ year for level II) years’ experience in global customer service/order management with a strongly developed commitment to client services
  • 2+ years 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

APPLY

We are seeking a Cell Culture Bioprocess Engineer or RA to conduct bioreactor application study, scale-up/down and single-use product development with Repligen’s XCell™ ATF technology and recombinant growth factors for biologics protein production. This position resides within the Research and Development group and will report to the Senior Director, Upstream Bioprocess Development.

Responsibilities:  

  • Perform lab scale feedbatch and perfusion bioreactor operation and engineering scale-up/down to demonstrate performance of XCell ATF system and growth factors in industrial CHO cell culture applications
  • Participate in single-use product development, conduct product mechanical testing, characterization and qualification studies
  • Perform application study design and data analysis, write summary report and present findings
  • Provide customer technical support and troubleshooting
  • Work on joint technology projects with Manufacturing and with partner companies and customers

Qualifications: 

  • BS/MS in biochemical or biomedical engineering, cell/molecular biology, biochemistry or related fields with solid understanding of cell culture principles
  • 2-5 years’ experience in cell culture/fermentation process development (media design and bioreactor process optimization and scale-up/down) in the biotechnology/pharmaceutical industry
  • Aseptic technique and hands-on experience in media design, fed-batch or perfusion bioreactor operation, controller configuration/automation, and cell retention device (XCell ATF or TFF) setup are required
  • Familiarity with single-use product development (mechanical testing, characterization, applications study, extractables and gamma sterilization study) is highly desirable
  • Superior analytical and problem solving skills
  • Excellent oral and written communication skills
  • The ability to work independently and in a team setting, as well as flexibility to work off-hours and weekends (on as needed basis) are also required

APPLY

LUND, SWEDEN

     No current openings

WEINGARTEN, GERMANY

This position will be responsible for performing the physical tasks involved in the shipping, receiving, storing and distributing of products, materials, parts, supplies and equipment.  Unpacks and checks goods received against purchase orders or invoices, maintains records of received goods, rejecting unsatisfactory items where necessary.    Pulls and fills orders.  May use (but not limited to) power equipment such as a forklift, hand tools and other devices operated in a warehouse environment.  Prepares and maintains records of merchandise shipped.  Posts weights and shipping charges and prepares goods for final shipment.   Examines stocks and distributes materials in inventory and on manufacturing lines.   Prepares kitting packages for assembly production. 

Key Responsibilities

  • Loads and unloads product to and from delivery vehicles and designated storage areas
  • Reads production schedule, customer orders, work orders, shipping orders or requisitions to determine items to be moved, gathered or distributed
  • Conveys materials and items from receiving or production areas to storage or other designated areas
  • Sorts and places materials or items on racks, shelves or in bins according to predetermined sequence such as: size, type, style, color or product code
  • Fills requisitions, work orders or request for materials, tools or other stock items and distributes items to production workers or assembly line
  • Assembles customer orders from stock and places orders on pallets or shelves, or conveys orders to packing station or shipping department
  • Marks materials with identifying information
  • Opens bales, crates and other containers
  • Records amounts of materials or items received or distributed
  • Weighs or counts items for distribution to ensure conformance to company standards

APPLY

FIELD

We are seeking a highly motivated & experienced Sales Manager 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 & Baltic states.  

The ideal candidate will demonstrate a high level of motivation to succeed, highly developed sales & 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 function.

The ideal candidate will have an excellent working knowledge of English & German.

Responsibilities: 

  • Meet or exceed sales and profitability targets
  • Promote and sell a portfolio of upstream, downstream & single use products
  • Develop and execute a territory management plan
  • Conduct sales negotiations with technical & planning departments
  • Establish & maintain Strategic Key Account relationships
  • Develop new accounts
  • Drive sales & manage customer relationships with a market leading CRM tool
  • Provide accurate & timely sales reporting and forecasting
  • Maintain contact with key market infrastructure partners & identify new sales & 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 trade show activities

Qualifications: 

  • A minimum of a BSc degree in a scientific discipline or equivalent
  • A minimum of 5+ years’ 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 region and to the US
  • Attention to detail, excellent verbal and written communication skills, good analytical and problem solving skills, and strong organizational skills

APPLY

The Field Service Engineer (FSE) is responsible for installing, maintaining and servicing XCell ™ ATF products in Europe. The FSE will provide remote and onsite support and work closely with the sales and product managers in troubleshooting customer needs. The FSE shall maintain accurate documentation of all service activities and escalating issues as needed. The position will be based in Europe.

Responsibilities:

  • Provide service support, including repair and preventive maintenance, for equipment and document all service activities. Service will be executed at customer sites and at a Repligen location in Germany.
  • Perform installation and training on equipment, software, and other accessories; report back on issues, orders and parts needed
  • Perform Site Acceptance Testing (SAT) on ATF products at customer sites globally
  • Schedule and perform preventative maintenance on equipment as required;
  • Problem-solving tasks may include resolving mechanical/software issues; resolving operating system bugs; and reinstalling software or hardware
  • Enhance the customer’s positive experience by recognizing their needs and providing solutions that meet and often surpass those needs
  • Communicate effectively both internally and externally, to document actions and item performed, schedule future preventive maintenance needs, and other engineering functions. Communicate routinely with Field Service Manager based in the US and other FSEs globally.
  • Provide phone support to customers and service group personnel related to equipment hardware and software performance and service part ordering.
  • Document and distribute technical information regarding resolutions to field problems, hardware and software changes, and product quality improvements
  • Review service manual documentation to ensure accuracy and current revision levels
  • Determine appropriate preventive maintenance procedures, service parts kits, and schedules to ensure effective on-going equipment maintenance

Qualifications:

  • Bachelor's Degree or Technical School (Electronics)
  • At least 5 years of experience in the repair, maintenance, and installation of equipment used in a laboratory or bioprocess settings
  • Electronic and mechanical aptitude required
  • Maintains professional and technical knowledge
  • Strong written and verbal communication skills
  • Ability to draft and execute SOPs
  • The position requires up to 50% travel in Europe and occasional global travel

Repligen is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Repligen provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran.

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