Open Positions

Process Development Engineer, Drug Product

Job Code (PD-PDE2017)

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 seeking a process engineer experienced in drug product process development and manufacturing to join our Pharmaceutical Development (CMC) team.

The ideal candidate will have a B.Sc., M.Sc., or Ph.D. in chemical engineering, chemistry, biochemistry, or related field, with significant experience developing sterile parenteral drug product manufacturing processes spanning multiple platform technologies and unit operations including sterile filtration, UF/DF, disposable and stainless-steel technologies, tangential flow filtration (TFF), high shear homogenization (liposome production), spray drying, syringe and vial filling etc. In addition, experience with high viscosity sterile filling operations and/or oral dosage form production is highly desireable. Candidates should have hands-on experience with the development and execution of fill/finish technical operations and reporting as well as batch record authorship and review, equipment procurement and qualification, and cGMP’s to allow for effective oversight of third party CMO activities supporting Ra Pharma needs. The successful candidate should be an excellent communicator and extremely well organized. Experience with design control of medical device combination product is highly desirable.

Responsibilities:

  • Design, lead and execute bench scale process development activities, as well as provide oversight to 3rd party scale up of drug product manufacturing including sterile filtration, fill/finish, and compounding across a diverse range of sterile product unit operations.
  • Provide technical review of 3rd party batch records and related GMP documentation (e.g., raw material specifications, equipment specifications, validation, supportive development protocols / reports).
  • Effectively communicate with vendors and internal team members and key stakeholders across the CMC team on the status, objectives, risks, and mitigation plans associated with ongoing plans and activities for ensuring a robust and high quality clinical / commercial drug supply.
  • Work directly with various 3rd parties to support development, qualification, supply, and cGMP manufacture / packaging / labeling.
  • Maintain drug product database containing pedigree of all GMP manufacturing and development activities (i.e., raw material lot #’s, assay, yield, deviations, and other performance attributes).
  • Maintain critical quality attribute, in-process and release data tracking and trending analysis as well as in-process equipment parameter tracking and trending analyses.
  • Assist in providing ‘man in plant’ oversight to GMP related activities by 3rd party suppliers.
  • Lead and assist with all drug product clinical technical transfer efforts to 3rd party CMOs.
  • Ensure complete and effective investigations (i.e., root cause and CAPA) are conducted and documented to support the quality of drug supply.
  • Conduct formal Risk Assessments to support Phase 3 registration and submission.
  • Help oversee 3rd party development and qualification activities including Extractable / Leachables, CCI, Autoinjector, and sterile filtration.
  • Assist Quality Assurance in conducting supplier audits.
  • Author and support writing the drug product sections of CMC regulatory filings.

Knowledge / Skills:

  • Strong understanding of development of sterile DP processes from development batches through scale up and commercialization.
  • Experience with clean room personnel / material flows, and aseptic processing functional and regulatory requirements
  • Experience with drug product compounding, biodisposable and stainless steel strategies, sterile filtration, mixing strategies, fluid transfer to and from various compounding vessels/biobags, QC sampling requirements
  • Current in cGMPs and how to implement process designs and systems that promote cGMP compliance
  • Computer literate in Excel, Word, Visio

Salary and Title commensurate with experience. Please submit cover letter and resume to hr@rapharma.com.

Manager, Regulatory Affairs

Job Code: RAF 2017

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.

Description: Ra Pharma is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Sr. Specialist/Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive.

Responsibilities:

  • With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
  • 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.
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents.
  • Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.
  • Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.

Qualifications: The ideal candidate should have a minimum of 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 NDAs (desirable), and supportive amendments and supplements (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.

Salary and title commensurate with experience. Please submit cover letter and resume to hr@rapharma.com.

Process Development Chemist or Engineer

Job Code: CMCPC2017

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.

Description:

We are seeking an experienced chemist or engineer to join our pharmaceuticals development team and contribute to the pre-clinical and early phase development of peptide, peptidomimetic, and small molecule drugs.

The ideal candidate will have a B.Sc., M.Sc., or Ph.D. in chemistry or chemical engineering, or related field, with significant solid-phase peptide synthesis and synthetic process development experience. Candidates should have hands-on experience with manual and automated solid-phase peptide synthesis and standard techniques in small molecule synthesis. Additionally, candidates should have experience with preparative and analytical HPLC as well as deep knowledge of key characterization techniques for peptide and small molecule drugs. Experience with cGMP processes and with CMC regulatory filings is preferred. The successful candidate should be a natural leader with excellent communication skills and the ability to work in teams and across disciplines.

Responsibilities:

  • In house scale up of discovery lead compounds for support of pre-clinical and pre-formulation investigations
  • Establishing initial scalable synthetic and purification processes for peptide, peptidomimetic, and small molecule drug candidate manufacture either internally or with CMO partners in support of pre-clinical and early phase studies
  • Solid-phase peptide synthetic and purification process development to make scalable, reproducible, and transferable processes for use in CMO manufacture of clinical phase materials.
  • Communication with CMOs and preparation of technical transfer documents in consultation with other internal Pharma Development team members.
  • Prepare technical development protocols and reports. Writing and support of drug substance sections of CMC regulatory filings.
  • Maintain instrumentation and laboratory process instrumentation and equipment.
  • Serve as a representative of CMC/pharmaceutical development group on project teams and help drive pre-clinical and early phase CMC activities

Salary and Title commensurate with experience. Please submit cover letter and resume to hr@rapharma.com.

Sr Dir/Dir/Associate Dir, CMC Program Management

Job Code CMCPM 2017

Ra Pharmaceuticals is looking to strengthen its Pharmaceutical Development team with the addition of a CMC Program Manager. Ra is a growing biotech company headquartered in Cambridge Boston. Focused on novel therapeutics for rare diseases, Ra employs both macrocyclic peptides and traditional small molecules to address dysfunction of the Complement cascade.

The pipeline at Ra Pharmaceuticals encompasses; RA101495, a macrocyclic peptide inhibitor of C5 currently entering phase II; an extended release version of RA101495; Factor D inhibitors for rare systemic renal disorders and dry AMD; as well as two projects in lead identification / lead optimization (C1 inhibitor and C5 oral small molecule)

As the pipeline matures we are looking to strengthen our Pharmaceutical Development group by recruiting key leadership and providing project management. We are currently recruiting for a motivated individual to join the team and lead CMC Project Management. The ideal candidate is expected to have a strong project management expertise, be able to lead through influence and motivate teams and external vendors to keep on task.

The CMC Program Manager will work closely with CMC teams, a diverse network of vendors and Program Teams to ensure achievement of deliverables, communication of project goals and expectations as well as help drive decision making, identify resource limitations, help minimize impact on timelines and maintain the development budget.

Responsibilities:

  • Serve as an integral CMC team member across multiple development projects to achieve development, manufacturing and project goals
  • Work collaboratively with CMC functions (Early Development, Analytical Development, Drug Substance Development, Drug Product Development, Supply Chain, Quality Control, Quality Assurance, and Regulatory) to ensure strong, clear communication to identify, avoid or address issues in Pharmaceutical Development and Manufacturing
  • Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various CMC projects, as well as ensure CMC teams are aware of current integrated program timelines
  • Work with vendor network to maintain relations, to address conflicts in thoughtful and productive manner, negotiate work plans and timelines. Ensure deliverables are met.
  • Develop and maintain detailed and integrated CMC project plans to identify/communicate project interdependencies as well as critical path activities across multiple development programs
  • Provides expertise and strategic guidance to multi-functional project teams as a Pharmaceutical Development representative
  • Track project tasks and efforts associated with Pharmaceutical Development, CMC, manufacturing, quality and supply chain.
  • Interact with clinical teams to project drug needs, presentation and timing
  • Work with DS and DP department heads as well as an outsourced Clinical Supply Management to manage manufacturing scheduling and logistics
  • Facilitate CMC team meetings to drive cross-functional communication, timely and effective decision making, and successful execution of CMC objectives
  • Help foster a team culture of scientific curiosity, high productivity, ownership, and accountability

Requirements and Job Qualifications:

The successful candidate will be a confident leader with significant experience and success in project management; have a strong desire to apply Project Management skills to deliver novel medicines to improve patients’ lives; and an understanding of CMC, drug development, strategies, practices and regulatory agency expectations

  • S./ M.S./Ph.D. in pharmacology, chemistry, biochemistry or a related discipline.
  • Minimum of 8 years of pharmaceutical/biotechnology project management experience.
  • Minimum of 4 year’s hands-on expertise in drug development as well as managing research performed at external CROs.
  • Experience with late stage development highly desirable
  • Experience with IND, NDA, IMPD and MAA filings is desirable
  • Excellent writing and language skills along with strong communication and team management skills
  • The ability to adapt to a fast-paced environment and meet aggressive timelines
  • Exceptional organizational and interpersonal skills as well as an ability to drive results through influencing others are a must
  • Strong detail orientation and driven to achieve
  • A strong knowledge of program budget processes

To apply, please send your résumé/CV and cover letter to hr@rapharma.com.

Head of Preclinical Development

Job Code HPD2017

Ra Pharmaceuticals is a growing biotech company headquartered in Cambridge, Massachusetts. Ra is focused on novel therapeutics for dysfunction of the Complement cascade in rare diseases. The company was founded on a macrocyclic peptide platform although the pipeline has matured to include both macrocycles and traditional small molecule approaches to inhibition of the Complement cascade.

Ra Pharmaceuticals has successfully delivered its most mature project, RA101495, a macrocyclic peptide inhibitor of C5, into phase II and completed a successful IPO in October 2016. The emerging pipeline consists of several projects reaching candidate selection in 2017 (Factor D for rare systemic renal disorders and/or dry AMD, an extended release version of RA101495), as well as two projects in lead identification / lead optimization (C1 inhibitor and oral small molecule C5 inhibitor projects)

As our pipeline matures, we are looking to strengthen our Preclinical Development group by recruiting key leadership and consolidating the functions of safety/toxicology and DMPK. Therefore, we are currently recruiting for a Head of Preclinical Development, with salary and title commensurate with experience. The ideal candidate is expected to have a strong core understanding of toxicology, immunotoxicity, ADME and pharmacokinetics derived from either direct line leadership of one or several of these functions or significant experience in leading projects into clinical development.

As a senior member of the R&D Leadership Team, this position will be expected to be a key contributor to developing Ra’s pipeline. As such, this individual, will work seamlessly from research into clinical development working closely with clinical functions and regulatory.

Responsibilities:

  • Build and lead a preclinical development team to head count target of 6-8 FTEs in 2017. Thereafter, assess portfolio needs and requirement for further additional FTE 2018+.
  • Lead toxicology and DMPK to oversee all non-clinical studies required for regulatory filings, clinical stage testing and product approval.
  • Oversight of IND-enabling PK/PD, Modeling and Simulation.
  • Leadership of the stage-appropriate development and implementation of bioassays for preclinical and clinical studies.
  • As a member of the R&D Leadership team, provide oversight and guidance to all R&D activities in the company and ongoing input to the Executive Leadership team
  • Provide strategic and hands-on management ensuring that toxicology studies are conducted in line with the appropriate regulatory guidelines and standards (FDA, WHO, GLP, and ISO).
  • Oversight of Preclinical Development budget. Initiate and manage contracts in conjunction with finance group, coordinates activities with select Contract Research Organizations (CROs) and academic collaborators for preclinical development in the areas of toxicology, pharmacology, pharmacokinetics.
  • Prepare reports, regulatory documents and INDs.
  • Work closely with other functional areas and colleagues to ensure all studies are performed in a quality, timely and scientific manner.
  • Provide preclinical expertise, and strategy, to multi-functional project teams as the preclinical representative.
  • Ensure compliance with GCP, GMP, and regulatory guidelines as appropriate.

Requirements and Qualifications:

The successful candidate will be a confident leader with rigorous scientific intellect and standards. The successful candidate will have significant prior success in building and leading Preclinical Research organizations and developing novel medicines that progress through development, ideally to approval and commercialization, and possessing the following qualifications:

  • D. in pharmacology, physiology or related discipline.
  • Minimum of 12 years of pharmaceutical/biotechnology industry experience.
  • Minimum of 7 year’s hands-on expertise developing and managing preclinical studies including those performed at external CROs.
  • Mastery of preclinical drug development, strategies, practices and FDA regulations.
  • Experience with biologics and related immunological studies required.
  • Demonstrated proficiency in nonclinical study design and management.
  • Demonstrated results in preclinical development and a track record of successful IND, NDA and BLA filings.
  • Previous experience and success with choosing and managing relations with external contractors, including CROs.
  • Experience interacting with U.S. and European regulatory authorities.
  • Experience with all phases of clinical development, including pre-IND through Phase IV programs and associated regulatory filings.
  • Excellent writing and language skills along with strong communication and team management skills.
  • The ability to adapt to a fast-paced environment and meet aggressive timelines
  • Strong leadership and interpersonal skills; The individual should have a track record of developing teams and participating in developing culture and people across an organization.

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

Head of Formulation

Job Code FD 2017

Company Description

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.

Position Description

Ra is currently looking for a Head of Formulation to lead the formulation development efforts for our preclinical and clinical drug development programs. This role will be responsible for parenteral formulation development as well as oral small molecule and peptide formulation development. Responsibilities also include dosage form preparation for preclinical studies. The Formulation Development Leader will draw upon sound scientific principles to direct formulation development activities while also demonstrating the organizational skills necessary for documenting activities and clearly presenting data, study findings, and rationale for the development path forward. This function works closely with Ra cross functional groups as well as external service providers including Process Development and drug product GMP Manufacturing. Working collaboratively with other scientists and disciplines (pharmacology, chemistry, pharmaceutical development, toxicology and clinical) this role will develop formulations and establish a robust Drug Product stability profile.   This individual will work across multiple project teams and be a central formulation resource in the company.

Experience with the following is highly desirable:

  • Parenteral dosage form development (subcutaneous)
  • Formulating highly lipophilic and/or lipid molecules
  • Authoring formulation relevant regulatory filing sections
  • Process development and process/technology transfer
  • Working with Contract Research/Manufacturing Organizations
  • Forced degradation and stability studies

Requirements

  • A MS or PhD degree in Chemistry or a closely related subject
  • At least 6 years of pharmaceutical development experience with focus on drug product development
  • Demonstrated ability and direct hands-on experience with developing parenteral formulations. Experience with developing subcutaneous sustained release formulations is highly desirable.
  • Successful development of formulations for clinical evaluation. Late stage formulation development highly desirable
  • Demonstrated ability and direct hands-on experience with developing highly lipophilic small molecule formulations. Experience with liquid fill capsules (such as soft gelatin capsules) is highly desirable.
  • Experience with GLP/GMP requirements during clinical development and registration
  • Excellent organizational, writing, communication and negotiation skills with a proven track record of being self-directed while managing multiple projects
  • Proven ability to work in a cross-functional, matrixed, and collaborative environment
  • Proven ability to effectively manage external manufacturing organizations / collaborators
  • Ability to thrive and develop in a biotechnology culture
  • Execute studies and research with a sense of urgency with ability to adhere to strategic program objectives while also operating/directing hands-on R&D activities.

Please resume and cover letter to HR@rapharma.com

Formulation Development Research Associate

Job Code FDRA 2017

Company Description

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.

Position Description

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.

Job Responsibilities:

  • 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 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 hr@rapharma.com