Current Openings


Recruitment Agency Notice

Recruitment Agencies interested in developing a relationship with NewLink Genetics, please send an email to: providing the following: Your full name, email address, phone number, name of agency, and your agency’s area of specialty. We will contact you directly if there is a business need for your services. All recruiters must have a written agreement in place prior to submitting any resume or curriculum vitae. Resumes submitted without an agreement and/or resumes sent through e-mail accounts of NewLink employee’s, other than Human Resources, are not eligible for placement fees and does not imply any obligation by NewLink. All employment opportunities are managed by NewLink’s Human Resources Department.


Facility Engineer

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Facility Engineer provides engineering support for the facility, equipment and utility related functions. Additionally, the Facility Engineer will oversee facility and equipment validation, preventative maintenance, calibration, house-keeping, and pest control programs.

Responsibilities:

  • Provide direction and guidance to facilities personnel. Assures the effective use of personnel, timely, and effective completion of required work
  • Plan and direct the installation, testing, operation, maintenance, and repair of facilities and equipment
  • Establish and implement good engineering practices
  • Oversight of the preventative maintenance and calibration programs
  • Oversight of facility and equipment validation
  • Analyze technology, resource needs and demand to plan and assess the feasibility of projects
  • Leads cross-functional efforts related to technical issues/problems related to their role
  • Works with Finance to develop capital and facility operating budgets
  • Supports site Investigation, Quality and Compliance Activities
  • Ensures compliance with federal (FDA, EPA, OSHA) state and local regulations

Qualifications:

  • Experience managing contractors/consultants for facilities/equipment projects
  • Must be able to work within time constraints and to think and respond quickly
  • Must possess reasoning, computation, and problem solving skills
  • Must be able to work on and around equipment, have good manual dexterity with the ability to use hand and power tools, and have free range of motion
  • Must have the ability to climb ladders and lift up to 35 lbs

Education and Experience:

  • B.S Degree in engineering discipline preferred
  • 5-10 years of experience within pharmaceutical industry strongly preferred
  • Experience in parenteral drug and biologics a plus

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Quality Assurance Associate

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Quality Assurance Associate will be responsible to review Batch Production Records. On a as needed basis the Associate might also perform other activities pertaining to assuring compliance with applicable regulatory requirements.

Responsibilities:

  • Reviews Batch Production Records

On a as needed basis:

  • Assists in reviewing other Good Manufacturing Practice (GMP) records and raw data, and supporting documentation and records for internal accuracy, consistency, and conformance with current Good Manufacturing Practices (cGMP)
  • Assists in Internal Auditing
  • Assists in Line Clearance
  • Assists in other Quality Assurance duties

Qualifications:

  • Strong attention to details
  • Excellent communication and organizational skills
  • Highly self motivated
  • Fluent in Microsoft Word and Excel
  • Flexible and able to deal with frequent change initiatives

Education and Experience:

  • Bachelor's degree (B.S.) preferred or related experience and/or training

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Quality Assurance Associate - Technical Writer

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Quality Assurance Associate will be responsible to write, review, and edit quality as well as technical and scientific SOPs, to create Visio flowcharts, and to perform other activities pertaining to assuring compliance with applicable regulatory requirements.

Responsibilities:

  • Writes, reviews, and/or edits quality as well as technical and scientific SOPs
  • Captures existing work flows and processes, as well as guidances and regulations into SOPs and flowcharts
  • Assists in reviewing GMP records, raw data, and supporting documentation and records for internal accuracy, consistency, and conformance with cGMP
  • Performs other Quality Assurance duties as required

Qualifications:

  • Must have scientific knowledge (e.g. Bachelor in Biology or other related scientific field, working experience in a laboratory, or other equivalent education and/or experience)
  • Must have excellent writing and editing skills, and strong knowledge in english grammar
  • Must be fluent in Microsoft Word, Excel, PowerPoint and Visio
  • Strong attention to details
  • Excellent communication and organizational skills
  • Highly self motivated
  • Flexible and able to deal with frequent change initiatives

Education and Experience:

  • Minimum of a Bachelor's degree (B.S.) in Biology or related scientific field preferred
  • Degree in English or writing is a plus
  • Quality Experience is a plus
  • Experience within regulated industry is a plus

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Quality Assurance Raw Material Specialist

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Quality Assurance Raw Material Specialist will be working in a cGMP environment and will be responsible to perform routine raw material lot dispositions to manufacturing and responsible for assuring compliance regarding raw materials with applicable regulatory requirements.

Responsibilities:

  • Performs routine raw material lot disposition to manufacturing
  • Receives, inspects, and keeps inventory of samples for the QC reserve sample program
  • Reviews and approves associated Raw Material Specifications and SOPs and ensures that appropriate revisions are made
  • Reviews and approves raw material related records such as Bill of Materials and Inventory Control records
  • Performs routine walkthroughs of warehouse facilities for cGMP compliance and general housekeeping
  • Works closely with Supply Chain to qualify and review suppliers
  • Assists in Quality events regarding to raw materials
  • Performs other Quality Assurance duties as required

Qualifications:

  • Must be able to work with dry ice and liquid nitrogen
  • Strong attention to details
  • Highly self motivated
  • Fluent in Microsoft Word and Excel

Education and Experience:

  • BA/BS Degree in Technical or Science Disciplines
  • Experience in a GMP environment or other regulated industry is a must

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Information Systems Specialist

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Information Systems Specialist position is part of a small, but growing team managing all aspects of NewLink Genetics' Information Systems from implementing, maintaining, and supporting hardware and software solutions, to assisting with the development, implementation and enforcement of information workflows and processes.

Responsibilities:

The candidate's responsibilities may include but not limited to the following:

  • Support and maintenance of enterprise applications including Enterprise Resource Planning, and Quality Management systems
  • Administration and Support of virtual system environments for both servers and desktops
  • Administration and Support of Microsoft and Linux server environments
  • Administration and Support of data storage systems including iSCSI and NFS protocols
  • Administration and Support of Networking and IP Telephony
  • Knowledge of ITIL/Enterprise IT governance procedures including Change Management, and Incident Management
  • Knowledge of 21 CFR 11 and Computer System Validation
  • Developing and maintaining documentation for the implementation, maintenance and support of systems
  • End user support including complex problem solving with project development and project management as well as standard support for both onsite and offsite users
  • Specialized development of workflows, small apps, scripts, etc. to accommodate automation or end user requests
  • Keeping the rest of the IS team up to date on progress through both voluntary and structured means

Qualifications:

The candidate should demonstrate the ability to:

  • Work in a fast-paced, ever changing environment that may include both primary and secondary roles and responsibilities
  • Work under a flexible schedule that may include some off-hours (evening and weekend) work
  • Apply technical knowledge to execute complex troubleshooting as well as develop solutions to meet business needs
  • Efficiently resolve end user concerns in occasional high-pressure situations
  • Train, mentor, and evaluate future additions to the team
  • Show a strong sense of self-motivation and intuitive including the ability to work independently under general direction

Experience in the following areas is a plus:

  • Virtual environments on VMware ESXi and/or Microsoft Hyper-V platforms
  • Microsoft Server OS and Applications including but not limited to Active Directory, Server 2008/2012, SharePoint 2010/2013, SQL Server 2012, Exchange 2010/2013, System Center 2012, and Deployment Toolkit 2012
  • Linux OS and application administration including but not limited to Fedora/RHEL, BIND, Samba, Apache, Progress-DB, My-SQL
  • Network administration including but not limited to TCP/IP (IPv4 and IPv6), DNS, Packet Filtering, NAT, DHCP, 802.11Q VLANS, QoS, Cisco CLI
  • Administration of Network Added Storage using iSCSI and NFS
  • VoIP

Education and Experience:

  • At least 2 years of experience in an Information Technology position are required. 5+ years preferred
  • An Associates or BS Degree in an IT related field is strongly preferred
  • MCSE/MCSA , ITIL or other technology certifications are a plus

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Part-Time GMP Cleaning Associate

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

Description:

  • Responsible for cleaning GMP ISO 8 areas, gowning and staging areas, Inventory Control, Quality Control Biosafety Level II Laboratory, locker rooms, and hallways on a daily basis for 4 hours per day. Working hours are flexible.
  • For daily cleaning of ISO 8 areas, gowning and staging areas, the part time GMP cleaning specialist will need to follow written procedures regarding clean room behavior, gowning requirements, and cleaning instructions. Gowning will consist of wearing protective sterile full body gown over scrubs, booties, gloves, hood, and goggles. Being fully gowned up as specified is a must. Cleaning of these areas will consist of cleaning floors, walls, and ceiling.
  • Will be cleaning the Quality Control Biosafety Level II Laboratory on a weekly basis
  • Will be cleaning the Inventory Control Room on a bi-weekly basis

Requirements:

  • Must be willing and able to clean up to 4 hours per day Monday - Friday
  • Must be willing and able to clean walls and ceilings
  • Must be willing and able to pass Gowning Certifications
  • Must be willing and able to pass Blood Borne Pathogen Training
  • Need to be proficient in the English language – Reading, Writing and Communicating

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Supply Chain Manager

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Manager will be responsible for the expanding and optimizing warehouse/supply chain operations to support the preparation of the Biologics License Application (BLA) for a cell based oncology immunotherapy currently in late phase clinical testing. Additionally, the Manager will be responsible for working with Quality Assurance to develop and/or revise SC procedures to ensure vendor/supplier audits, material qualifications, and other functional area procedures are cGMP compliant.

Responsibilities:

  • Direct the activities of all functions involved in the purchasing, planning, warehousing and control of materials from the receipt of forecasting replenishment needs to the delivery of final product into inventory and potentially to distribution.
  • Develop strategies, policies, procedures, and overall team to optimize value of the entire function
  • Hire and supervise staff as needed to achieve corporate objectives
  • Lead and coach direct reports in maintaining excellence in cGMP compliance, quality control, and safety
  • Participate in existing and new product planning processes to assure timely acquisition of materials to support production schedule
  • Participate in the design and implementation of new ERP system and optimize its use
  • Manage vendors/suppliers and establish secondary suppliers for critical materials
  • Lead negotiation efforts for major contracts
  • Draft, edit, review and approve applicable SOPs and protocols to ensure cGMP compliance

Qualifications:

  • Strong planning, project management, and analytical skills
  • Proven interpersonal communication skills and ability to work in a team environment
  • Demonstrated ability to prioritize and multi-task in a fast paced environment
  • Proficient in Microsoft Office applications and electronic data base systems
  • Proven experience in interviewing, hiring, and building a high functioning productive team
  • Highly self motivated
  • Flexible

Education and Experience:

  • College or university degree in business administration or in a discipline related to logistics or warehouse management or pertinent industry experience
  • 5+ years of experience in all aspects of supply chain/warehouse logistics strongly preferred
  • 2+ years of supervisory/management experience preferred
  • Experience in biotech/pharmaceutical warehouse operations a plus
  • Prior experience in supporting successful BLA submissions is a major advantage
  • Experience in final product packaging and distribution is a plus
  • CPM or CPIM certification a plus

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Manager of Technical Operations

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Manager will be responsible for working with Quality Assurance to develop and maintain cGMP compliant procedures in support of Biologics License Application (BLA) for a cell based oncology immunotherapy currently in late phase clinical testing. Additionally the Manager will be responsible for working with Process Development, Manufacturing, and Quality Assurance to develop new product introduction protocols and requirements for products in early phase clinical testing.

Responsibilities:

  • Hire and supervise staff as needed to address projects in process characterization/qualification, process development, and manufacturing scale-up
  • Direct and motivate direct reports to achieve corporate objectives
  • Work with QA to develop and maintain cGMP compliant processes to ensure manufacturing compliance in; deviation resolution, change control, corrective and preventative actions, and training.
  • Work with MFG, QA, QC, and PD to ensure new product introduction requirements are met for new manufacturing products
  • Write and review documents for regulatory submissions
  • Draft, edit, review and approve applicable SOPs and protocols

Qualifications:

  • Must have scientific and technical expertise in culturing mammalian cells
  • Must have pharmaceutical or biotech industry experience in cell culture manufacturing production
  • cGMP experience in manufacturing clinical and/or commercial biologics
  • Excellent communication and organizational skills
  • Highly self motivated
  • Flexible

Education and Experience:

  • 5 years of cell culture process development experience strongly preferred
  • At least 2 years of experience within regulated industry preferred
  • At least 2 years of experience management experience very helpful
  • Prior experience in supporting successful BLA submissions is a major advantage

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Research Associates in Vaccine Production

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

We are seeking two Research Associates in Vaccine Production to join our current good manufacturing practice, cGMP, organization. The Research Associates in Vaccine Production will participate in cancer vaccine production regulated by the FDA.

Responsibilities:

  • Work in an environmentally controlled facility for the production of anticancer vaccines for ongoing clinical trials.
  • Scale-up, harvest, formulate, and fill, mammalian cells as defined by standard operating procedure (SOPs) and batch production records (BPRs)
  • Perform aseptic cell culture operations in ISO 5 biosafety cabinets
  • Maintain equipment and facility used for cGMP manufacturing processes
  • Perform process characterization/development studies to ensure manufacturing procedures are well characterized and robust
  • Create, revise, and update, cGMP documentation as required

Qualifications:

  • Knowledge in cell biology and cell culture techniques
  • Knowledge in aseptic technique
  • Strong attention to detail
  • Self motivated
  • Experience in Microsoft Word and Excel
  • Strong people skills and the ability to work as a member of a team

Education and Experience:

  • Bachelors Degree in Life Sciences or 4+ years of proven work experience in a related field strongly preferred
  • Experience in aseptic techniques associated with culturing cells a plus

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Method Development Quality Control Associate

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Method Development / Quality Control Associate will be responsible to assist in the development and qualification/validation of cell biology assays for quality control purposes. Later the Associate will also be assisting in performing Quality Control tests. The Associate will be working in a cGMP environment and will be reporting to the Director of QA/QC.

Responsibilities:

  • Assisting in the development and optimization of cell biology assays
  • Assisting in the qualification and validation of Quality Control methods
  • Assisting in performing Quality Control tests
  • Performing other Method Development / Quality Control duties as required

Qualifications:

  • Knowledgeable in cell biology assays
  • Experience with mammalian cell cultures
  • Experience in aseptic techniques
  • Strong attention to details
  • Highly self motivated
  • Fluent in Microsoft Word and Excel

Education and Experience:

  • Bachelors Degree in Life Sciences or equivalent experience

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA

Clinical Research Associate

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.

The Clinical Research Associate will monitor activities at our clinical study sites to assure adherence to federal regulations, Good Clinical Practices (GCPs), Standards of Procedures (SOPs), and study protocols.

Responsibilities:

  • Must be able to travel between 65% - 80% of the time including overnight stays.
  • Weekly travel may be required at times.
  • When not traveling, CRA will work on generating clinical documents, entering and managing trial data, and supporting all functions of clinical trial management.
This is in-house position

Education and Experience:

  • BS/BA or equivalent combination of education and experience in a healthcare or scientific discipline preferred
  • Strong understanding of Medical Terminology
  • Strong organizational skills
  • Excellent written and verbal communication skills
  • Computer literate and proficient in MS Office
  • Ability to work independently and take direction from others is required
  • Proven flexibility and adaptability with team building skills
  • Ability to utilize problem-solving techniques applicable to a constantly changing environment.
Applicants must be authorized to work for any employer in the US

We offer a diverse workforce with a competitive salary and benefit package.

Please apply using the linked Application Form

EOE/AA


NewLink Genetics participates in the United States Department of Homeland Security E-Verify program. This is a federal program designed to help certify that employees hired are eligible for employment in the US.

NewLink Genetics is an Affirmative Action/Equal Opportunity Employer

Request Disability Accomodations

Important E-Verify Information
Please read the attached notices for important information when applying for work with NewLink Genetics.

E-Verify Notice:
English
Spanish

Right to Work Notices:
English
Spanish