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 s=XCell™ ATF single-useproduct line.

Responsibilities: 

  • 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

Qualifications: 

  • 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

APPLY

The successful candidate will be responsible for assisting the document control department revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner.   

Responsibilities: 

The Quality Assurance Associate II will actively participate in the Repligen ISO 9001 Quality Management System and will be responsible for the review of production and Quality Control batch records. The ideal candidate will have knowledge of chromatography column packing processes and an understanding of analytical techniques (pH and conductivity), and basic microbiology (bioburden and environmental monitoring). Knowledge of advanced biochemical analysis such as HPLC is preferred.

This position involves completing the QA review of production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing chromatograms. Other activities include the review of analytical data for analytical reagents used, verification of calculations, and evaluation of results for out of trends and out of specifications of the product. Ability to identify process deviations, assist with the writing of root causes, and identification of corrective actions to prevent recurrence, is highly preferred.

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
  • Identification of 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

Qualifications: 

  • Bachelor’s degree in Biological Science or other science related discipline
  • Understanding of basic chromatography (production and lab scale) is required for this position
  • Familiarity with fermentation and purification processes and analytical data review is preferred
  • Understanding of Good Documentation Practices preferred.
  • Minimum 2-4 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent

APPLY

The Senior Production Scheduler position is responsible for developing production/supply plans which take into account forecasts, availability of material and manufacturing capacity. The incumbent is responsible for identifying and maintaining the appropriate planning parameters in MRP system to optimize subassembly production and raw material supply plans. This individual will be the point of contact for supply escalations from Customer Service, Sales and Product Management.  May also be responsible for providing materials to manufacturing areas based on planned production schedules and for the appropriate shipping of finished goods to various distribution centers in support of management policies for customer delivery and inventory levels.

Additionally, the Senior Production Scheduler will work closely with Manufacturing, Manufacturing Engineering, Development and Quality to ensure an efficient and effective supply of components and sub-assemblies to support manufacturing.  As well as support and contribute to any continuous improvement activities for service level improvement and process efficiencies.

Responsibilities:

  • Plan production requirements based on forecast from global operations leader and product management.
  • Evaluate and execute all MRP plans to meet corporate initiatives.
  • Liaison between business leaders and manufacturing.
  • Support ERP/MRP implementation.
  • Support product management with new product launches, product improvements and changes, and product rationalization.
  • Lead potentially high visibility teams requiring accurate and timely data analysis and the ability to meet project deadlines.
  • Develop, implement and manage metrics to track overall success and effectiveness.  Including but not limited to: On time delivery, line item fill rate, inventory reporting, and capacity reporting.
  • Data analysis and decision making to support raw material supply and finish goods demand.
  • Implements short and long range inventory strategies.
  • Recommends solutions to complex inventory issues.
  • Negotiates issues related to planning and logistics.
  • May be required to support procurement activities.

Qualifications: 

  • Bachelor’s Degree in manufacturing operations, business administration, operations management, or purchasing.
  • 5-8 years’ planning or procurement experience, preferably in a high paced working environment.
  • APICS or ISM certification is strongly desired.  Some experience in a scientific environment.  Knowledge of chemistry or biology a plus.
  • Strong project management and team leadership skills with the ability to develop strong support for change with all levels of internal and external organizations.
  • Strong organization skills with the ability to manage and prioritize multiple tasks.
  • Effective interpersonal and negotiation skills.
  • Ability to make decisions and solve practical problems with a variety of variables in situations where standardization may be limited.
  • Self-driven, results oriented, and motivated to work effectively with minimal direct supervision.
  • Previous ERP experience a must.
  • Proficiency with off-the-shelf database applications.

APPLY

SHREWSBURY, MASSACHUSETTS, USA

       No current openings

LUND, SWEDEN

Processoperatörer till Repligen Sweden

Har du intresse för kemi och erfarenhet av processarbete inom industrin? Vi söker dig som vill vara med och tillverka produkter som bidrar till att bota bl.a. cancer, och som är tillgänglig för skiftarbete.

Om företaget

Repligen är ett amerikanskt Life Science-bolag med produktion i Boston samt i Lund. Företaget, som är noterat på den amerikanska NASDAQ-börsen, bedriver bl.a. storskalig tillverkning av proteiner som används som tillväxtfaktorer och affinitetsligander inom läkemedelsindustrin. Verksamheten utmärks av höga kvalitetskrav, ständiga förbättringar och utveckling av produkter och processer. Repligen Sweden är både kvalitets- och miljöcertifierade enligt ISO9001 och 14001.

Repligen expanderar och vi söker nu tre processoperatörer till vår produktionsanläggning på S:t Lars i Lund. Du ingår i en avdelning om 30 personer som ansvarar för fermentering, upparbetning, rening och fyllning/frystorkning av företagets produkter. Tjänsten innebär skiftarbete.

Arbetsuppgifter

Arbetsuppgifterna som processoperatör innefattar att utför arbetet efter standardiserade dokument och styr processerna efter givna metoder.  Du arbetar i skift under dag, kväll och natt.

Utbildning, erfarenhet och personliga egenskaper

  • Lägst gymnasieexamen inom kemiteknik/naturvetenskap
  • Högre akademisk utbildning (meriterande)
  • Erfarenhet av processarbete inom industrin
  • Arbetslivserfarenhet från GMP/ISO (meriterande)
  • Svenska i tal och skrift samt engelska i skrift

För att bli framgångsrik i rollen är du noggrann och strukturerad i ditt arbete och trivs med att arbeta enligt kvalitetssystem med noga beskrivna rutiner. Eftersom att ditt arbete i stor grad påverkar resultatet av produktionsprocessen är du lojal med en hög ansvarskänsla och pålitlighet. Vidare är du ärlig och kommunikativ med en hög samarbetsförmåga. Du respekterar och följer processer och regler, både gällande arbetsmoment samt hygienkrav. Slutligen trivs du med praktiskt arbete och tycker det är spännande med ett ständigt förbättringsarbete.

Övrig information

Start: Omgående/enligt överenskommelse

Plats: Lund

Lön: Enligt överenskommelse

Sökord: operatör, processoperatör, Life Science, bioteknik, kemi, produktion, naturvetenskap, läkemedel, GMP, ISO, Lund, heltid

https://jobb.bravura.se/lediga-jobb/processoperatorer-till-repligen-sweden-1289901/

WEINGARTEN, GERMANY

       No current openings

FIELD

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.

Responsibilities:

  • 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

Qualifications:

  • 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

APPLY

We are seeking a US, West Coast based Field Application Scientist to technically support the TangenX® product line in the US.  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 domestic and some international travel.  The position will be based on the West Coast, California preferred.

Responsibilities: 

  • 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

Qualifications: 

  • 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% domestic travel and occasionally internationally.

APPLY

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.

Responsibilities: 

  • 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.

Qualifications: 

  • 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.

APPLY

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. 

Responsibilities: 

  • 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.

Qualifications: 

  • 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

APPLY

Repligen is seeking a highly motivated and experienced Sales Specialist 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 West Coast of the United 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 of North America. This is a home office based role, preferable in the Bay area, however, any West coast location will be considered for the right person. Depending on location, 50% travel will be necessary.  

Responsibilities:

  • 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

Qualifications:

  • A minimum of a BSc degree + in a scientific discipline or equivalent
  • A minimum of 5+ years of experience in the biopharmaceutical or life science industries. A strong understanding of Cell Culture, Chromatography and Filtration is a priority. However, additional skills and understanding and Upstream and Downstream processing would also be beneficial
  • Proven successful sales track record and key account management experience
  • Proven ability to build mutually beneficial, personable, 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, Multi-tasking skills, and strong organizational skills

APPLY

We are seeking a US based Field Application Scientist to technically support the XCell ATF product line in the US.  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 including Sales Account Managers, Product Management, Quality Assurance, and Development Scientist and 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 domestic and some international travel.  The position will preferably be based on the West Coast.  

Responsibilities:

  • Work in coordination with the Repligen Sales team 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 VOC.
  • Develop and execute project plans to meet customer wants and 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.

Qualifications:

  • 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 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

APPLY

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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