Research Associate to Scientist Analytical Development
Job Code: AD2017
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 a resourceful and motivated individual to join our team as an Associate Scientist, Scientist or Senior Scientist. This candidate will have a supportive role in Analytical Development and will apply his/her knowledge to develop analytical methods, design experiments, and manage reference standard/stability analysis. 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 3-8+ years of industry experience in analytical development or quality control with a proven track record of strong analytical technique developing and troubleshooting analytical methods. Previous experience characterizing and quantifying peptides, analytical method validation, and managing stability studies and reference standards 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.
- BS/MS in Analytical or Organic chemistry or a related field
- 3 to 8 years of industry experience
- Experience with peptides, small molecule and/or protein analytical method development and characterization and purification techniques 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
Please send resume and cover letter to email@example.com
Director/Senior Director, Quality Assurance
Job Code: DQ2017
The Director/Senior Director of Quality Assurance is responsible for leading and strategically directing the Quality organization and is accountable for the design, development, execution and administration of a GxP Quality System meeting all compliance requirements globally from Ra Pharmaceuticals and Regulatory Agencies with respect to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
The Director/Senior Director of Quality Assurance will develop, maintain, and continually improve the Global Quality Management System, including corporate GxP standard documents as needed, maintain the Quality Assurance audit database, oversee CAPA/deviation documentation and tracking, audit documents, and 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.
- Represent Quality Assurance in company project meetings to ensure regulatory and ethical compliance requirements.
- Promote communication among the team(s) by leading regular meetings with pertinent updates and other developmental activities.
- Mentor and develop the assigned team(s) by establishing and implementing performance measures.
- Recommend solutions to complex quality issues and work closely with senior management to resolve significant compliance trends and issues.
- Extensive interface with and influence of company’s global functional leadership
- All other duties as assigned by the SVP, RAQA
- Assist business functional areas in developing and implementing global/regional processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Develop 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
- Conduct and/or manage internal audits to ensure compliance to all relevant policies and procedures. This includes the issuance of audit reports and facilitation of timely closure of corrective actions by the respective departments.
- Perform audits against GxP standards (e.g., GMP/GCP/GLP/GVP/computer validation), FDA/EMA/PMDA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues.
- Implement GCP Quality Assurance programs for clinical trials execution and reporting.
- Perform external audits of suppliers/vendors.
- Ensure continuous inspection readiness.
- Lead the participation, coordination and responses to audits and inspections.
- 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. Work independently with internal GMP systems and personnel, work within technical teams with external material and service providers. Supports the production schedule to meet clinical and nonclinical study needs, and develops product quality compliance strategy and plans for future product supply.
- 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. Lead in resolution of quality non-compliance issues in production and testing at vendors. Identify areas of improvement.
- Manage Quality Assurance relationships with GMP service providers; work with CMO QA and technical teams to resolve discrepancies, noncompliance events. Review and edit Quality Agreements, provide quality input to project plans, master service agreements and statements of work. Perform GMP audits.
- Review technical and study reports, CMC sections of regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested, for compliance with Ra documentation, established standards, and regulations.
- Approve/supervise approval of clinical investigation medicinal product labels for release to production, ensuring proper quality and compliance standards are met, as required
- Ensure robust planning and execution of documentation for product release.
- Review product complaints and quality event documentation for accuracy.
Quality Metrics, CAPAs, and Deviations:
- Lead Quarterly Management Reviews
- Review and update quality manuals, SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGMP/GDP standards, FDA/EMA/PMDA/ICH and all competent authority regulations and requirements.
- Generate metrics and trending reports. Identify and mitigate gaps.
- Responsible for oversight, on behalf of Ra, of vendors’ CAPA’s, deviations, and investigation reviews and final dispositions.
- Oversee/develop the employee training program including assessments and its effectiveness, in collaboration with business functions.
- Coordinate, develop, and prepare training materials (e.g. PowerPoint presentations) and training sessions (e.g. audio-conferences)
- Train others on and advance Ra GMP Quality System and Quality System documentation.
- Identify, communicate, and schedule training opportunities and/or training notices.
- Maintenance and audits of corporate training records and training curricula.
- Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field
- Minimum 10 years of experience in Quality Assurance with at least 5 years of experience in 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 all aspects of GMPs and CMC for Phase 2 to 3 phase products, including product development, analytical sciences, validation, regulatory processes and quality control.
- 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.
- Experience with regulatory compliance inspections. Proficiency with interpreting and implementing GXPs, FDA, EMA, PMDA 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 and leadership skills to mentor and develop team to achieve Company goals. Demonstrated ability to effectively lead professional staff
- 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, Access, Outlook, PowerPoint, and Project.
Please send resume and cover letter to firstname.lastname@example.org.
Formulation Development Research Associate
Job Code: FDRA 2017
Ra Pharmaceuticals (NASDAQ RARX), a clinical-stage biopharmaceutical company based in Cambridge MA, is focused on the discovery, development and commercialization of novel therapeutics based on its proprietary peptide chemistry platform. Ra is developing therapeutics to treat serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system. Ra Pharmaceuticals is assembling a team of highly motivated and experienced professionals who are committed to improving the lives of patients and building a world class biotechnology company.
We are currently looking for a Formulation Development Research Associate to assist 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 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 in drug product process development studies, process optimization, scale up and tech transfer to 3rd party CMO’s.
- 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.
- BS/MS in pharmaceutics, biochemistry, chemistry or a related discipline and up to 4-6 years of experience in a research, development or manufacturing environment working with formulation or analytical development. Experience with general laboratory procedures such as buffer preparation, reagent preparation as well as good documentation skills.
- Aseptic technique desirable
- Motivated and able to work with minimal supervision
- Able to solve technical problems with enthusiasm in a team environment
- Able to function with general instructions on routine work, detailed instructions on new assignments.
- 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
Please send resume and cover letter to email@example.com
Clinical Supply Manager
Job Code: 2017PDCSM
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.
Ra Pharma is looking to appoint a motivated Clinical Supply Manager (CSM) to contribute to the development of pharmaceuticals in the Ra pipeline. The primary purpose is to ensure the continuous supply of investigational medicinal product to the clinic. You will manage all IMP packaging, labelling and device assembly as well as distribution, supply chain and supply depots. The CSM will monitor and maintain inventory levels at supply depots and clinical sites as well as update and maintain IMP expiry. Further, this role will be responsible for pre-commercialization drug supply activities such as defining and validating supply chain operations. This role is highly collaborative and cross functional, interfacing with the Drug Product Development, Clinical Operations, Quality Assurance and Regulatory Affairs.
- Demonstrated strategic thinking and planning ability
- Assist in forecasting IMP supply to ensure timely IMP production
- Review clinical trial synopses and understand impact on supply
- Collaborate with Clinical Operations to identify demand assumptions: enrollment rate, number of sites, number of countries, etc.
- Review clinical trial protocols and understand impact on clinical supply
- Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Pharmaceutical Development and Clinical Operations for studies and/or programs
- Ensure changes in supply configuration, trial design, enrolment timelines, manufacturing availability and regulatory requirements are considered and incorporated into manufacturing and supply plan
- Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
- Manage label development process, expiration dating and updating as well as packaging timelines
- Coordinate US and international distribution and logistics with CMOs
- Develop IRT and participate in User Acceptance Testing
- Participate in cross-functional Project Team Meetings
- Develop and maintain applicable metrics
- Review and update SOPs and identify the need for a assist in establishing new departmental procedures
- Bachelor’s degree in life sciences or business major
- 5+years of pharmaceutical industry experience in supply chain management (rare disease and/or parenteral dose form (cold chain) preferred).
- Experience in CMO management, including labeling, packaging, and distribution in North America and Europe
- Experience with IRT/IWRS system and implementation
- Knowledge of cGMPs and relevant FDA and EU Regulations
- Familiarity with US and EU regulatory agencies and their guidance
- Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
- Ability to multi-task and work in a fast paced and dynamic environment
- Strong organizational skills
- Must be able to infrequently travel domestically/internationally
Desirable characteristics include:
- Demonstrated strategic thinking and planning ability
- Demonstrated problem-detection and problem-resolution skills
- Organizational skills with a proven track record of being self-directed while managing multiple projects
- Excellent verbal and written communication skills; good interpersonal skills.
- Ability to drive external vendors to deliver quality results on time
Title and Salary commensurate with experience. Please send resume to HR@rapharma.com.