Current Openings

Executive Assistant

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:

We are currently looking for an Executive Assistant who will be responsible for providing support to the Chairman of the Board/CEO and the President and other executive management.

Responsibilities:

  • Performing complex and confidential administrative functions for executive personnel
  • Develop, draft and type written correspondence
  • Managing and maintains complex calendars
  • Provide solutions regarding inquiries
  • Make travel arrangements for executives
  • Prepare documentations and make arrangements for meetings and conferences including board committees and board meetings
  • Screen incoming calls and correspondence and responds independently when possible. 

Qualifications:

  • Proven experience as an assistant to a senior executive in a professional environment is strongly preferred
  • Must be able to maintain confidentiality of all corporate, personnel and research matters
  • Must pay keen attention to detail with the ability to demonstrate diplomacy and discretion. 
  • Ability to organize and prioritize daily work activities, meet deadlines and multitask effectively. 
  • Excellent oral and written communication skills along with being an independent thinker and problem solver is a must. 
  • Must be proficient in Word, Excel, Outlook and PowerPoint
  • Bachelor’s Degree or 10 plus years administrative experience, with 5-7 years supporting senior executives strongly preferred. Minimum of 2-3 years corporate experience preferably in a biotechnology or pharmaceutical environment

Please apply using the linked application form:
Application Form
NewLink has a diverse workforce with competitive salary and benefit packages.

EOE/AA

Manager of External Reports

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.

To ensure that the financial results of the company are reported in accordance with Generally Accepted Accounting Principles and rules and regulations of the Securities and Exchange Commission. To assist in identifying and communicating to key stakeholders, the impacts of new or proposed accounting interpretations, pronouncements or other technical literature and to assist in the development of accounting for highly technical areas in conjunction with the Finance team.

Responsibilities:

  • Lead in preparation and filing of SEC Form 10-K annually, SEC Form 10-Q quarterly, and other SEC forms as required (8-Ks etc).
  • Responsible for financial reporting and disclosure controls.
  • Prepare monthly financial reports for management.
  • Support obligations under SEC filing requirements for Forms 3, 4, and 5.
  • Provide support for quarterly reviews and annual audit performed by external auditors.
  • Gather information from multiple internal and external sources; developing spreadsheets and other supporting data; completing analyses, writing reports, and preparing presentations.
  • Work primarily on projects with the most substantial complexity, breadth of scope, and impact to the organization.
  • Collects data on actual financial performance, compares to forecasted performance, analyzes variances and prepares periodic and ad-hoc reports.
  • Constructs and maintains financial models in support of the development of forecasts and reporting processes.
  • Performs financial analysis associated with special projects.
  • Manage calendar of events with all internal constituents
  • Develop and implement appropriate documentation and review standards prior to filing – train others to assist in quality control reviews
  • Stay current on new GAAP or newly relevant GAAP. Insure timely documentation of key issues and relevance to company for review and decision making by management / other relevant parties
  • Assist in developing/maintaining adequate Sarbanes Oxley compliance process as it relates to required financial controls/disclosures

Qualifications:

  • A Bachelor’s degree in Finance, Accounting, Business Administration, or closely related field and 4-6 years of progressively responsible professional-level financial analysis experience, to include experience managing medium to large-scale projects strongly preferred.
  • An Expert working ability in Excel, a thorough knowledge of Generally Accepted Accounting Principles.
  • Telecommunications, experience preparing and submitting SEC filings, and CPA designation is preferred.

Please apply using the linked application form:
Application Form
NewLink has a diverse workforce with competitive salary and benefit packages.

EOE/AA

Scientific Director of Development and Validation

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 Director will be responsible to provide expedited method validation and process validation support during the preparation of Biologics License Applications for a family of oncology therapies with products now in late Phase clinical testing. The Director will report directly to the Clinical and Regulatory Compliance Officerand directly communicate with executive management.

Responsibilities:

  • Supervise and allocate staff as needed to address projects in method development and qualification/validation and process development/validation
  • Designs method development, qualification, and validation protocols for characterization of mammalian cells including viability, growth kinetics, FACS, and ELISA assays.
  • Provides scientific, technical, and cGMP oversight of biologic processes and methods
  • Writes and reviews documents for regulatory submissions
  • Drafts, edits, reviews and approves applicable SOPs and protocols.

Qualifications:

  • Must have scientific and technical expertise in characterization of mammalian cells
  • Must have pharmaceutical or biotech industry experience in method development, qualification and validation
  • Excellent communication and organizational skills
  • Highly self motivated
  • Flexible

Education and Experience:

  • PhD  in cell biology or other related science field
  • At least 5 years of experience within regulated industry
  • Prior experience in supporting successful BLA submissions is a major advantage

Please apply using the linked application form:
Application Form
NewLink has a diverse workforce with competitive salary and benefit packages.

EOE/AA

Quality Assurance Manager in GMP for Biologics

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 Manager will be responsible for performing and maintaining a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements. The QA Manager will be supervising very few employees and will be expected to spend most of his/her time hands-on in all areas of responsibilities. This position is reporting to the QA Director.

Responsibilities:

  • Internal Auditing
  • Deviations and Investigations Program
  • CAPA Program
  • Change Control Program
  • Complaint Program
  • Reviews and approves GMP records, raw data, and supporting documentation and records for internal accuracy, consistency, and conformance with cGMP
  • Drafts, edits, reviews and approves applicable SOPs
  • Performs other Quality Assurance duties as required

Requirements:

  • Excellent communication and organizational skills
  • Strong attention to details
  • Highly motivated
  • Fluent in Microsoft Word and Excel
  • Flexible

Education and Experience:

  • A minimum of a Bachelor's degree (B.S.) in a scientific area strongly preferred
  • At least 3 years of experience within regulated industry is a plus

Please apply using the linked application form:
Application Form
NewLink employs a diverse workforce and offers competitive salary and benefit packages.

EOE/AA

Research Associate 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 a Research Associate in Vaccine Production to join our current good manufacturing practice, cGMP, organization.  The Research Associate 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 preferred
  • Experience in aseptic techniques associated with culturing cells a plus

Please apply using the linked application form:
Application Form
NewLink employs a diverse workforce and offers competitive salary and benefit packages.

EOE/AA

Research Associate Organic Chemistry


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 a Research Associate in Organic Chemistry to join our current medicinal chemistry group. The candidate will be working under supervision of a PhD chemist. 
Responsibilities:

  • Will work under direct supervision of a PhD chemist
  • To synthesize and purify molecules to support our small molecule discovery program.
  • Set up organic synthesis reactions and conduct multi-step synthesis,
  • Use chromatographic techniques to purify compounds
  • Characterize novel compounds using analytical techniques such as NMR, IR and mass spectrometry
  • Order materials and keep chemical inventory
  • Organize and interpret data.  

Qualifications:

  • Knowledge in organic chemistry, chromatography, HPLC
  • Capable of following instructions and applying them in an independent way
  • Organized and detail-oriented
  • Ability to work as a member of a team
  • Experience in Microsoft Word and Excel

Education and Experience:

  • Bachelors or Masters Degree in Chemistry/Life Sciences/Biology
  • 1-5 years of experience in organic chemistry laboratory.

Please apply using the linked application form:
Application Form
NewLink employs a diverse workforce and offers competitive salary and benefit packages.

EOE/AA

Research Associate in Analytical Chemistry


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 a person responsible for providing analytical compound characterization by HPLC and LC/MS and compound purification by preparative HPLC to support the organic synthesis efforts of our drug discovery program. In addition, this person will provide support to our bio-analytical group by performing analysis of biological samples from our PK/ADME. Position will commensurate with experience and qualifications.

Responsibilities:

  • Will work under supervision of a PhD chemist, but will have a significant degree of independent responsibilities.
  • To analyze the purity, yields and identity of molecules coming from organic synthesis using chiral and non-chiral HPLC and LCMS
  • To purify organic molecules using preparative HPLC
  • To perform analysis of biological samples by LCMS
  • To carry out metabolite identification in biological samples

Qualifications:

  • Knowledge in organic chemistry, chromatography,
  • Experience in analytical and preparative HPLC and LCMS
  • Experience in LCMS and HPLC method development and validation
  • Experience in metabolite identification is desired but not required
  • Organized and detail-oriented
  • Ability to work as a member of a team
  • Experience in Microsoft Word and Excel

Education and Experience:

  • Bachelors or Masters Degree in Organic Chemistry or Analytical Chemistry
  • More than 4 years of experience in analytical/bio-analytical chemistry.

Please apply using the linked application form:
Application Form
NewLink employs a diverse workforce and offers competitive salary and benefit packages.

EOE/AA

Scientist in Pharmcokinetics, Pharmacodynamics and Toxicology (PK/PD/Tox )


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 a person responsible for planning, coordinating and executing animal experiments to determine the pharmacokinetic and toxicology profile of novel drug candidates as well as testing their immune and antitumor effects.

Responsibilities:

  • Plan, coordinate and execute animal experiments related to pharmacokinetics, toxicology and pharmacodynamics
  • Write animal experimentation protocols to be submitted to IACUC.
  • Develop reliable animal tumor models and antitumor in vivo assays to compare the activity of compounds of interest

Qualifications:

  • Experience in pharmacology, particularly in the areas of in vivo testing (PK/PD/Tox)
  • Knowledge and experience in tumor biology, tumor immunology and immunology
  • Highly motivated, organized and detail-oriented
  • Ability to work as a member of a team

Education and Experience:

  • PhD in Immunology, Pharmacology, Biology
  • More than 3 years of experience in pharmacology and tumor immunology involving working with different animal models.

Please apply using the linked application form:
Application Form
NewLink employs a diverse workforce and offers competitive salary and benefit packages.

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

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