Open Positions

Research Associate/Associate Scientist – Discovery Biology

We are currently seeking a highly-motivated and collaborative Research Associate/Associate Scientist to join the Discovery Biology team. The selected candidate will assist integrated cross-disciplinary efforts to develop the next generation of innovative small molecule and peptide therapeutics for diseases driven by complement dysregulation. The candidate will be expected to develop biochemical and biophysical assays aimed at the discovery, characterization, and optimization of novel therapeutics.

Primary responsibilities:

  • Design, develop, execute, and troubleshoot diverse biochemical and biophysical assays including SDS/Native-PAGE, Western blot, Pull-down, ELISA, and enzyme activity and protein-ligand binding assays using a broad range of fluorescence, luminescence, and SPR-based formats.
  • Perform data analysis such as IC50 determination, interpret and document research data and present the results to project teams to enable data-driven decisions.
  • Act as team member in project teams in a fast-paced, highly integrated, collaborative research environment. Engage with external CRO as needed.
  • Actively assess, adopt and implement emerging technologies and experimental techniques to enhance our research capabilities in support of target identification and hit/lead molecule characterization
  • Execute with attention to detail, demonstrate critical thinking of data and concepts, provide consistently high-quality data, and maintain a safe working environment

Requirements:

  • M.Sc. in biochemistry, biophysics or related discipline with 2+ years of industry research experience in biotech or pharmaceutical settings
  • Strong interest in contributing to medicinal chemistry drug discovery efforts to evaluate compound SAR and mode of action characterization
  • Hands-on experience in developing biochemical and biophysical assays for proteins and protein-ligand interactions
  • Track record of troubleshooting technical and assay-related challenges
  • Strong skills in data analysis and reporting, interpretation, organization, and presentation
  • Team player with excellent communication and inter-personal skills
  • Preferred qualifications include
    • Hands-on experiences in label-free technologies (e.g., SPR, LC-MS) and fluorescence-based assay techniques (e.g. HTRF, FP, quench assays)
    • Experience in automated liquid handling instrumentation and assay miniaturization
    • Knowledge and research experience in autoimmune and inflammation disease drug discovery

To apply, please send resume and cover letter to hr@rapharma.com.

Regulatory Affairs Specialist II

Description:  Ra Pharma is seeking an experienced and energetic person to manage, evaluate, and complete regulatory submissions consistent with company goals.  The successful candidate will be responsible for overseeing operational aspects of all regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget. The position will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners.

RESPONSIBILITIES:

Under direction from, and in collaboration with the Director, Regulatory Affairs, the candidate will:

  • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
  • Manage document publishing for regulatory submissions from all areas of the company, in support of active INDs in eCTD format (formatting, publishing, submitting, life-cycling, and archiving sequences) such as clinical trial applications, IND/ODD annual reports, amendments; may include both paper and e-filings.
  • Manage outsourced publishing and records management vendors, as applicable.
  • Create and manage submission plans, in conjunction with Regulatory colleagues.
  • Represent Regulatory Affairs in project teams to support submission planning and ensure coordination of system development activities.
  • Reviews submission documents in accordance with the company’s high standards as well as global regulatory standards.

QUALIFICATIONS:

The ideal candidate should have a minimum of 3-5 years overall regulatory experience in the pharmaceutical industry. The candidate must have a BA/BS degree or equivalent in a health science field. Experience and knowledge in preparation of INDs, and supportive amendments (manufacturing, nonclinical, clinical). Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communication skills are a must, as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

To apply, please send resume and cover letter to hr@rapharma.com.

Director, Quality Assurance

The Director/Senior Director of Quality Assurance is responsible for the design, development, execution, and administration/maintenance of a GxP Quality Management System meeting applicable compliance requirements from Ra Pharmaceuticals and Regulatory Agencies with respect to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP).

The successful candidate will be responsible for maintaining the Quality Assurance audit database, managing the CAPA/deviation documentation and tracking system, auditing/reviewing internal and external documents, maintain the company’s training records, as well as provide overall Quality oversight to the manufacturing and supply chain process.

This individual will also identify procedures and opportunities which may be needed as the organization evolves, industry practices change, or regulations change.

Responsibilities

  • Represent Quality Assurance in internal and external meetings to ensure quality compliance requirements are met.
  • Assist business functional areas in developing and implementing processes, procedures, and systems to perform critical activities in an efficient and effective manner to ensure compliance with applicable regulations and company standards.
  • Develop and implement and/or revise corporate standard documents relating to GxPs such as quality manuals, policies, SOPs, work instructions, forms, reference documents, in collaboration with relevant business functions.
  • Develop, execute, and maintain the Ra Pharma document control system to ensure appropriate level of Quality oversight to GxP documentation.
  • Review and update quality manuals, SOPs, policies and processes regularly to ensure all quality standards are in compliance with GxP standards, FDA/EMA/PMDA/ICH and other applicable competent authority regulations and requirements.
  • Conduct and/or manage internal and external audits to ensure compliance to all relevant policies and procedures as required. This includes the issuance of audit reports and facilitation of timely closure of corrective actions by the respective departments.
  • Perform, manage and finalize external audits of suppliers/vendors and maintain vendor approval status.  This includes generation of an audit final report for vendor submission.
  • Ensure continuous inspection readiness.
  • Lead the participation, coordination, and responses to audits and inspections.
  • Administer, develop, and maintain the employee training program including assessments of its’ effectiveness, in collaboration with business functions.  Specifically: coordinate, develop, and prepare training materials (e.g., presentations) and training sessions, identify and schedule training opportunities for applicable personnel, and periodically audit site personnel training files.
  • Ensure compliance of manufacture and testing of product for clinical studies. Quality management of CMOs, contract test laboratories, and other vendor services in support of CMC of product. Lead in resolution of quality non-compliance issues in production and testing at vendors. Identify areas of improvement.
  • Establish and maintain appropriate development phase GMP compliance for product manufacture, testing, and stability; review and assess production and testing methods, specifications, validations, reference materials and test results.
  • Review applicable documentation from internal and external sources as well as applicable sections of regulatory submissions for compliance with Ra Pharma documentation, established standards, and regulations.
  • Approve clinical investigation medicinal product label text and proofs for release to production, ensuring proper quality and compliance standards are met, as required.
  • Review and track product complaints and quality event documentation.
  • Review and approve internal, and as necessary, external Drug Substance and Drug Product Certificates of Analysis for GMP use.

Quality Metrics, CAPAs, and Deviations:

  • Lead Quarterly Management Reviews.
  • Generate metrics and trending reports. Identify and mitigate gaps.
  • Responsible for oversight, on behalf of Ra Pharma, of vendors’ CAPAs, deviations, and investigation reviews and final disposition of drug substance and drug product.

Qualifications

  • Minimum Bachelor’s degree in science, pharmaceutical sciences, or related field
  • Minimum 10 years of experience in Quality Assurance with at least 5 years of experience working with GMP pharmaceutical development, manufacturing, and testing.
  • Preferred experience with peptide products, Phase 2 to 3 stage product development. Technical knowledge of analytical method qualification, process validation, and establishing product specifications.
  • Experience in working in compliance with US, EU, and ICH GMP requirements, experience with writing or reviewing submission documentation, responses to regulatory inquiries and inspections.
  • Preferred experience with Combination Device submissions and ISO Medical Device requirements for pre-filled syringes.
  • Preferred experience with GCP requirements and maintenance of required documentation and data.
  • Experience with regulatory compliance inspections. Proficiency with interpreting and implementing GXPs, FDA, EMA, PMDA, ISO and ICH Regulations and guidelines
  • Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
  • Excellent oral and written communication.
  • Strong interpersonal skills to effectively communicate with teams, peers, management, and external contacts.
  • Proven organizational skills and ability to lead cross-functional teams in order to implement an effective QMS.
  • Prior experience operating in and managing change control programs in the biotech /pharmaceutical industry. Broad knowledge of quality systems utilized in biotech /pharmaceutical industries.
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

To apply, please send resume and cover letter to hr@rapharma.com.

Analytical Development

JOB CODE: PD52018

Ra Pharmaceuticals, Inc. (NASDAQ: RARX), is a clinical stage biotechnology company focused on development of novel therapeutics for the treatment of serious diseases that are caused by dysregulation of the complement system, a critical component of the immune system. Ra Pharma combines its expertise in the area of complement biology with leadership in macrocycle peptide technology to discover and develop therapeutics that transform the lives of patients with life threatening disorders.

Description:  We are currently seeking resourceful and motivated individuals to join our team.  There are openings at the Associate and Scientist level available.  This candidate will have a supportive role in Analytical Development and will apply his/her knowledge to manage/review reference standard/stability analysis, develop analytical methods, and design experiments.  This person will also be responsible for supporting in-house analytical requirements including, but not limited to, solubility screening, forced degradation studies, small molecule and peptide purification, non-GMP stability studies and formulation development studies, and materials release.   Based upon experience, the candidate may oversee outsourced analytical method development, technical transfers, reference standard certification, GMP stability studies and material release.

Qualifications: The ideal candidate will have a BS/MS in Analytical or Organic chemistry or a closely related field and 3-5+ years of industry experience in analytical development or quality control/stability program with a proven track record of strong knowledge in stability program and developing and troubleshooting analytical methods.  Previous experience in managing/reviewing stability studies and reference standards data, characterizing and quantifying peptides, analytical method validation is preferred.  The successful candidate must be able to thrive and develop in a dynamic biotechnology start-up environment, to complete tasks with a sense of urgency, and to have a passion for scientific excellence.

Requirements:

  • BS/MS in Analytical or Organic chemistry or a related field
  • 3 to 5+ years of industry experience
  • Experience with GMP stability data review, peptides, small molecule and/or protein analytical method development including:
    • HPLC and UPLC methodology (reverse phase, size exclusion, ion exchange)
    • GC Methodology
    • Mass Spectroscopy (Quad, Q-tof and Q-Exactive).
    • Preparative Chromatography
    • QC wet chemistry
  • General familiarity with USP and EP compendial methods
  • Drive to solve problems and ability to work independently
  • Strong multi-tasking skills.
  • Excellent communication and writing skills

To apply, please send resume and cover letter to hr@rapharma.com.

Formulation Development Scientist

Job Code FDRA 2018

Position Description

We are currently looking for a Formulation Development Research Associate / Scientist to assist in the formulation development efforts for our clinical and preclinical drug development programs.  Working closely with the Formulation Development Group Leader, the successful candidate will assist in the development of pharmaceutical drug products by performing preformulation and formulation screening experiments, as well as preparing materials for preclinical studies.  Under general supervision, the candidate will work collaboratively with other scientists and disciplines (pharmacology, chemistry, pharmaceutical development, toxicology and clinical operations) to develop and prepare drug product test formulations for preclinical evaluation.  You will be expected to have excellent documentation skills and be able to summarize all activities and data to allow for experimental reproducibility and communicating the supporting rationale.   Most importantly the successful candidate will be self-motivated, capable of working independently and creatively under general supervision; able to follow instructions, generate data that can be traceable and substantiated, and assist with writing reports and data summaries.  As needed, the candidate may assist other departments/disciplines such as Analytical Development with method development, sample prep, analysis, etc.  Additionally, the candidate may support drug product process development studies, process optimization, scale up and tech transfer to 3rd party CMO’s.

Job Responsibilities:

  • Design and develop fit for purpose preclinical formulations (traditional and enabling)
  • Coordinate and contribute to drug substance and drug product characterization and stability studies to ensure optimal formulation development and selection.
  • Under minimal supervision, follows methods for the production and testing of new sub-cutaneous and oral formulations, technologies and products.
  • Assists with new product scale-up, process optimization, technology transfer and process validation activities.
  • Generates data to support the development of manufacturing procedures and product specifications. Write, review, and edit technical documents.
  • Maintains an accurate, timely, and GLP compliant laboratory notebook.
  • Participate in and contribute at team meetings.

Requirements:

  • BS/MS degree with >10 years or PhD degree with >5 years of relevant pharmaceutical industry experience working with formulation development. Solid understanding on pharmaceutical sciences and its interplay with other relevant scientific disciplines. Experience with peptide immediate and sustained release formulation development and/or small molecule solid dosage form development. .
  • Able to solve technical problems with enthusiasm in a team environment
  • Good written and oral communication skills.
  • Ability to thrive and develop in a biotechnology culture
  • Execute studies and research with a sense of urgency and attention to detail
  • Aseptic technique desirable

Please send resume and cover letter to hr@rapharma.com

Synthetic Medicinal Chemist

JOB CODE: MC2018

Our Medicinal Chemistry team is currently seeking an experienced, innovative chemist with the ability to generate and implement original ideas and contribute to the success of the team.  We are seeking a creative, energetic, and results-oriented individual, who possesses a track record of success. This individual will join a medicinal chemistry team and be required to perform synthetic organic chemistry in the laboratory at a high level as well as design and data analysis of targets and routes. The candidate will be expected to work independently as part of a collaborative research team.

Responsibilities and Expectations:

  • Multi-step organic syntheses of challenging medicinal chemistry targets within a project and documentation of experimental procedures
  • Proficiency in designing, executing and troubleshooting multi-step syntheses
  • Analysis of complex data sets and creation of design hypotheses
  • Outstanding leadership, interpersonal, communication, and time-management skills are essential
  • Active participation in discussions in medicinal chemistry team meetings to build and understand structure-activity relationships

Minimum Education & Experience Requirements: 

  • D. in synthetic organic chemistry, 3 years of industrial experience
  • Demonstrated capabilities in modern methods of synthesis and analysis
  • Knowledge of operation of standard laboratory instrumentation (NMR, LC-MS purification and analysis, chromatography)
  • Application of structure based drug design leading to advanced leads/ development candidates
  • Strong working knowledge of protein-small molecule interactions, conformational and structural analysis, experienced working closely with computational chemists and the use of computational and visualization tools
  • Good understanding of key ADME, biochemical and pharmacological principles and capable of effectively integrating these concepts into the optimization of lead compounds

Title and Salary commensurate with experience. Please send resume to hr@rapharma.com.

Scientist – Biology

Job Code: TB-1-2018

We are currently seeking a highly skilled, creative and motivated individual with a strong background in immunology to join the Biology team as a Scientist. Expertise in innate and adaptive (T cell) immunity, immune cell-endothelial cell interactions, and knowledge of autoimmune and inflammatory diseases is preferred. The candidate will be responsible for validating therapeutic targets and demonstrating efficacy of lead compounds using complex human in vitro cell models and in vivo models of disease. The candidate will also provide translational biology support to programs as they progress through clinical development.

Job responsibilities:

  • Impact biology strategy aimed at validating therapeutic targets and generating foundational data to support therapeutic indications for key compounds.
  • Independently design experimental approaches to model human disease in vitro and execute on plan and leverage team members to achieve goals as needed
  • Contribute to translational biology efforts by generating key data supporting identification of biomarkers of response predictive of disease progression and of responders to therapy
  • Design and oversee the execution of in vivo models that are conducted at CROs
  • Operate in a team-based setting and mentor lab members a needed
  • Contribute to achieving a high level of operational execution in Biology by enhancing our capabilities/technologies
  • Contribute to collaborations with academic investigators
  • Communicate data and strategy in various settings including senior leadership team and externally at conferences and/or to academic collaborators

 Qualifications: The ideal candidate will have a PhD in Immunology or closely-related field.  Postdoctoral work experience in immunology is preferred. A successful track record of conceptualizing experiments, leadership at the bench towards achieving goals and impactful communication is required. Hands-on experience in immunological cellular techniques including isolation and characterization of primary immune cells from human and animal tissues is required. An experience in thriving and delivering on goals through collaborations and team work is highly desired. The successful candidate must be able to lead, thrive and develop in a fast-paced and dynamic team environment, to complete tasks with a sense of urgency, and to have a passion for scientific excellence.

Requirements:

  • PhD in Immunology or a related field, with minimum of 2 years postdoctoral work preferred with proven track record of success that includes executing in team-based settings
  • Research experience in autoimmune and inflammatory diseases
  • Hands-on experience in immune cell isolation and characterization, multi-color flow cytometry, immune cell activation assays, and tissue culture
  • Ability to independently design, execute, and analyze experiments
  • Strong multi-tasking skills
  • Excellent communication, presentation, collaboration and organizational skills

To apply, please send resume and cover letter to hr@rapharma.com.

Purchasing Manager

Job Code: PM 5-2018

Company Description

Ra Pharmaceuticals, Inc. (NASDAQ: RARX), is a clinical stage biotechnology company focused on development of novel therapeutics for the treatment of serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system.  Ra Pharma combines its expertise in area of complement with leadership in macrocycle peptide technology to discover and develop therapeutics that transform the lives of patients with life threatening disorders.

Position Description

We are currently seeking a Purchasing Manager to be responsible for the enhancement of our procurement process, purchasing policies, procedures and requirements necessary to support a growing clinical stage company. The Purchasing manager will be responsible for the the company’s purchasing activities in accordance with Ra’s Procurement policies and guidelines. This is a hands-on position and the ability to multitask and work with others is essential. This individual will report to the Vice President, Operations.

Job Responsibilities

  • Develop and implement the overall purchasing process to support the Ra day to day operations
  • Manage system (NetSuite) implementations and upgrades and testing thereof
  • Partner with stakeholders to define and implement required guidelines and policies. Formalize procedures to ensure compliance with stated policies and controls, including audit
  • Manage purchasing process including approval and maintenance of vendor information coordination and follow up on open Purchase requisitions and orders
  • Identify and implement process improvements to enhance operational efficiency and effectiveness
  • Develop reporting tools and strategies to extend analytical capabilities into the organization.
  • Manage the order processing cycle times to ensure they meet internal business performance requirements
  • Assist the business securing competitive bids or quotes for existing goods/services as needed
  • Manage the Travel program and related resources/partners (e.g. AMEX, preferred suppliers)
  • Resolve day-to-day issues that arise relating to purchasing and contracts
  • Assist with SOX, financial and tax audits & reviews
  • As necessary train users on Ra’s procurement tools

Requirements

  • BS in Business Administration or a related discipline and a minimum of 5 years of experience in purchasing, preferably in a biotechnology environment
  • Experience with NetSuite is a must
  • Solid understanding of purchasing concepts
  • Proven experience in negotiating contracts
  • Ability to operate both strategically and tactically
  • Excellent written and oral communication skills
  • Strong interpersonal skills with the ability to work well with cross functional team member
  • Superior attention to detail and strong analytical skills
  • The ability to multitask and thrive in a fast-paced environment, be proactive and resourceful

Please send resume and cover letter to hr@rapharma.com