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
The QC Analyst will report directly to the QC Manager and will be primarily responsible for performing in-process testing of Repligen Bioprocessing ligands, and release of OPUS pre-packed chromatography columns. The analytical activities supporting this position include HPLC, SDS-Page, FTIR analysis and microbial testing (bioburden & endotoxin). The successful candidate will support activities for facilities including collection of Environmental Monitoring data in the ISO clean rooms as well as RODI collection and analysis. The candidate will actively follow Repligen ISO 9001 Quality Management System in support of the Bioprocessing manufacturing processes and final product testing, including additional laboratory compliance as assigned by the QC Manager.
- Performs final testing of finished OPUS® pre-packed chromatography columns and documents results for product release (bioburden and endotoxin)
- Performs in-process concentration analysis by UV and HPLC
- Performs sample preparation for FTIR analysis
- Perform RODI water testing
- Carries out monitoring of ISO controlled environments and records data for trend analysis
- Writing and reviewing SOPs, writing deviations, reviewing data of peer reviews
- Assists with OOS investigations and change controls associated with QC testing
- Requires college level education in Biology or related field and 4-8 years’ experience in Quality Control laboratory or equivalent
- Ability to work independently once training has been completed
- High attention to detail applied to all aspects of daily activities
- Ability to work efficiently in an ISO 9001 quality
- Strong HPLC experience and a good understanding of the fundamentals of column chromatography
- Experience with microbiological assays (Environmental monitoring, water testing)
- Experience with ELISA is a plus
- Gel electrophoresis
- FTIR (Fourier Transform Infrared Spectroscopy) experience is a plus
Repligen is looking for a Senior Accountant to support the Company and the Finance Department in its next phase of growth. The Senior Accountant is responsible for supporting the Company’s accounting and internal control activities with a primary focus on revenue recognition and general ledger activities. The individual will be responsible for monthly close procedures, maintaining accurate financial data and providing accurate and timely reports to the Corporate Controller and CFO.
- Review supply agreements, purchase orders and invoices to ensure proper recognition of revenue
- Preparation of revenue and deferred revenue related journal entries to support the month-end and year-end closing process
- Preparation of balance sheet account reconciliations
- Assistance with the analysis of month-end and quarter-end fluctuations in general ledger accounts
- Coordination with external auditors to complete quarterly reviews and year-end financial statement audits in a timely manner
- Assist in preparation of SEC filings
- Supporting the department’s Sarbanes Oxley efforts
- Providing solutions to improve departmental efficiencies
- Collaborating closely with other departments in all accounting related matters
- Perform special projects and analyses, as required
- Bachelor’s degree or higher in Accounting or Finance
- CPA preferred
- 3 to 5 years of Public Accounting experience preferred
- Strong knowledge of U.S. GAAP, primarily related to revenue recognition issues
- Willingness to learn quickly and take ownership
- Highly detail oriented and organized in work
- Ability to multitask and meet assigned deadlines
- Strong verbal, written and presentation skills
- Experience with Microsoft Dynamics GP a plus
- Strong working knowledge of Microsoft Excel
- Ability to work cooperatively and collaboratively with all levels of employees, management, and external agencies
- Ability to organize and manage multiple priorities; deadline oriented
Repligen is a trusted and forward-thinking partner in the production of biologics that improve human health worldwide, committed to supporting our customers with superior technology, service and applications expertise. We are executing on a focused growth strategy that involves ongoing innovation and collaboration, targeted acquisitions and commercial expansion.
- Provide coaching and guidance to managers regarding personnel management issues, including performance management, training, and organizational development and structure. Oversee and provide assistance with performance reviews, performance improvement plans and job descriptions.
- Formulate and recommend HR/people related policies, procedures and objectives for the organization to senior management. Lead team to implement changes.
- Work with hiring managers on new staff requisition requirements, including role specifications and profile requirements.
- Team with internal interviewer to help foster positive interviewing techniques.
- Establish effective on-boarding and off-boarding policies and practices. Ensure consistent implementation across the organization and follow through.
- Monitor organization compliance with federal and state laws (including FLSA, ADA, FMLA, MMLA, EEOC, ERISA, etc.). Ensure the Employee Handbook is up-to-date, reflecting current practices, laws and regulations. Directs the preparation of information requested or required for compliance, including all 5500 Form filings, 401(k) audit, workers compensation and summary annual reports. Act as a primary contact with labor counsel and outside government agencies.
- Manage the development and implementation of training and development programs for all staff. Identify internal needs and oversee relationships with external resources to provide necessary education and materials to management and staff.
- Develop, implement and manage staff recognition programs.
- Other duties as assigned with or without accommodation
- Occasional travel may be required
- Minimum of 8 years of experience in the HR field, preferably within a life sciences organization, demonstrating increasing levels of responsibilities.
- BS/BA degree
- SPHR/PHR preferred
- Experience with HRIS
- Demonstrated experience rolling out HR programs, initiatives
- Experience in mergers and acquisitions, integration and change management
- Experience in a global, multi-site environment
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).
- Cleaning, testing and assembly of multi-part plastic filter housing units in a classified cleanroom environment
- Buffer and media preparation
- Equipment and component cleaning and preparation
- Assembly and packaging of prepared chromatography columns
- Analysis of chromatography column performance
- Execution of 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
- 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 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
No current openings.
No current openings.
This role reports directly to the VP of Finance and is a proven professional, responsible for all technical and operational aspects of cost accounting for the company. This includes a hands-on knowledge of purchasing and manufacturing, intimate working knowledge of ERP systems, history of driving process and controls improvement and the ability to work effectively in a fast moving, cross-functional, environment.
The Cost Accountant will work closely with manufacturing, inventory control, purchasing, facilities, quality and other parts of the organization and is responsible for the inventory cost setting and maintenance, monthly variance analysis, gap resolution, financial close and operations related financial reporting.
- Manage monthly, quarterly and annual close processes, including the preparation of adjusting inventory journal entries, account reconciliations, accruals, excess and obsolete inventory reserve calculations and intercompany transactions
- Prepare monthly, quarterly and annual product gross margin analysis, including variance commentary and identification of process and cost saving opportunities
- Perform or support various inventory transactional processing in MS Dynamics (i.e. standard cost updates, scrapping, freight allocations, etc.)
- Monitor balance sheet accounts and prepare detailed account reconciliations for deferred COGS, capitalized variances, E&O reserves, etc.
- Monitor inventory-related SOX controls and establish and perform self-testing as required
- Coordinate quarterly physical inventory process and participate in loading counts into ERP system
- Design and implement a cycle count program, effective enough to eliminate quarterly physical inventory counts
- Partner with financial planning and analysis and operations teams to coordinate budgeting and forecasting, including materials, labor and overhead expense forecasting, standard cost setting, etc.
- Provide hands on implementation support for purchase accounting, acquisition integrations, etc., as required
- Perform special accounting analysis and projects, as requested
- Bachelor's degree in Accounting, with MBA and/or CPA preferred
- Cost accounting experience with mid or large sized company or national public accounting firm experience
- Very strong attention to detail and professional curiosity
- Strong Excel skills (comfortable with pivot tables/ large data manipulation)
- Strong understanding of US GAAP and SOX internal controls related to inventory reporting
- Experience in researching, developing and implementing accounting policies and procedures
- Excellent analytical and technical accounting skills
- Ability to organize and manage multiple priorities; deadline oriented
- Skilled in root cause, corrective action activities
- Excellent communication and inter-personal skills, both written and verbal
The Buyer/Planner I performs all functions needed to ensure the lowest total cost of purchased materials and services for a site. This is a service position and is responsive to the needs of internal and external (suppliers) customers. Primary responsibilities center on ordering and expediting direct materials, used by production to make finished product. Assist in the procurement of raw materials, using MRP to ensure that materials are available for the operation of the organization.
- Knowledge of procurement processes and supplier management
- Provide support to higher levels of the purchasing organization.
- Analyze and execute MRP into buy transactions on a daily basis
- Daily PO delivery maintenance
- Support local supplier relationships
- Negotiate low spend raw material and services agreements
- Support MRB activities and supplier corrective action on a daily basis
- Maintain PO delivery performance on a daily basis
- Support new part release planning data
- Resolve PO and invoice discrepancies for assigned suppliers and/or parts
- Participate in purchasing performance metrics: purchase price variance, on-time delivery, Site Supplier Quality Scorecards, PO Cycle Time, Site Raw Material
- Support PO, Blanket Order, and Consignment programs
- All other duties as required or assigned
- Associate degree or equivalent experience
- 1-3 year’s business experience
- High performance communication and execution skills
- Skilled in using ERP, Microsoft Excel, Word, Power Point, Outlook
- Demonstrate true understanding of the Laboratory Dialysis (LD) & Process Dialysis (PD) marketplace
- Lead Repligen’s product positioning, sales and marketing in the LD & PD market space
- Own the development, review, and execution of strategic project plans for standard Dialysis and Lab Products, including costing & pricing.
- Support the development of account based custom/special Dialysis products and interface with relevant departments.
- Identify new products and acquisition opportunities
- Responsible for maintaining distributor relationships and product support for Repligen’s represented portfolio
- Analyze, forecast and report sales revenues by product groupings, regions & sales channels
- Periodically make joint sales calls with the sales managers as required to support potential & existing accounts
- Determine cost assessment of potential custom dialysis products and propose quote pricing for field sales personnel
- Responsible for distributor sales of standard Lab and Dialysis products
- Become Repligen’s internal customer advocate ensuring that customers receive required technical and product support
- Develop a strong reputation for technical competence and a rapport with our customers and the market place in general
- Comprehend and support as needed the operational process flow from customer PO to product shipment
- Interface with customers, CS, sales, QC, R&D and manufacturing to address product and technology issues
- Develop and train our field sales personnel and distributors and be a technical resource to our external customer base
- Leadership ability to work across organizations while also demonstrating flexibility in interacting with individuals at all levels and business disciplines
- The strength and fortitude to be the customer and market advocate to the internal organization
- Proven ability to develop and manage project plans that deliver product information and marketing solutions to address the prioritized elements of the “gap” analysis
- Work with R&D to ensure alignment exists on R&D project plans and priorities
- Effectively manage resources
- Interface with Business and Market Development to ensure that the appropriate product marketing literature, sales collateral, website and PR materials are correct and executed to plan
- Champion and support Manufacturing and QA/QC operations in the development and implementation of market oriented cost reduction programs and QA program standards
- Capability of implementing an effective customer service function
- Administration for order entry and fulfillment
- Operations for product delivery, inventory management and QA response to customer complaints
- System for providing customers with technical support
Education and/or Work Experience Requirements:
- Bachelor’s degree in biology or related discipline required
- A minimum of 5 years’ experience in the biopharmaceutical or life science industries
- Previous experience in product management, technology/applications, sales & marketing and/or project management practices related to laboratory dialysis preferred.
- Skilled in analytical assessment and problem solving
- Proven ability to build mutually beneficial trusting relationships with customers, suppliers and internal business partners
- Strong organizational skills and able to manage project teams
- Excellent verbal and written communication skills
- Excellent computer skills including Microsoft Excel, Outlook, Word and PowerPoint
- Tests and inspects products at various stages of production process. Compiles and evaluates statistical data to determine and maintain quality and reliability of products.
- Selects products for tests at specified stages in production process and tests products for variety of qualities such as dimensions, performance and mechanical, electrical or chemical characteristics.
- Records test data, applying statistical quality control procedures.
- Prepares graphs or charts of data or enters data into computer for analysis.
- Receiving, inspecting and confirming complaints of Spectrum line products.
- Preparation of chemical solutions used in the lab.
- Maintenance of laboratory glassware and inventory.
- Assisting in development of inspection and ISO documentation as required .
- Contributing to team efforts as needed.
- Other duties as assigned.
- High School diploma
- Lab or manufacturing setting work experience
- Computer literacy desired
No current openings.
No current openings.
No current openings.
No current openings.